Amusa Proposal I

 

Burden and Outcomes of co-morbid Airflow limitation disorders in Heart failure

 

PRINCIPAL INVESTIGATOR: DR. AMUSA G ADENIYI

Cardiology Unit, Department of Internal Medicine, Jos University Teaching

Hospital.

drganiamusa@gmail.com, 08137713270                                                    

CO-INVESTIGATORS:               DR. ONUH A JAMES

                                                           DR UGURU SAMUEL

 

MENTOR:                                 PROF B.N OKEAHIALAM

                                                    DR AKANBI O MAXWELL

 

 

DATE OF COMMENCEMENT: JANUARY 2017

ABSTRACT

Background:

Heart failure (HF) and chronic obstructive pulmonary disease (COPD) are global epidemics, each affecting in excess of 1-3% of adult population.1,2 The prevalence of HF and COPD is on a steady increase in most parts of the world particularly in Nigeria due to a myriad of reasons e.g. epidemiologic transition, increasing rates of smoking, air pollution and use of biomass fuel e.t.c. 1,2 Both conditions incur significant morbidity and mortality, and present major management challenges to healthcare providers particularly when they co-exist.1 The reported prevalence of Airflow limitation particularly COPD in HF ranges from 11-52% 3-7, recent studies have reported a rising prevalence with increased morbidity and mortality in affected patients. In addition the Cardiovascular Health study reported a statistically significantly higher prevalence of COPD in HF patients compared to the normal population (20% vs. 13%, P = 0.001).8 Similarly, a significant percentage of patients with COPD and other airflow limitation disorders eventually develop HF.9-10

In patients with HF and concomitant COPD, COPD was consistently an independent predictor of death and HF hospitalization when reported in multivariable models.11-13 In many models the prognostic significance exceeded that of traditional factors including male gender, diabetes, hypertension, NYHA class, and anaemia.14 In the Val-HeFT trial, analysis of outcomes of participants with concomitant COPD identified that COPD strongly predicted mortality (HR 2.50 [1.58–3.96], P=0.0001) and hospitalizations (HR 1.71 [1.43–2.06], P=0.0001). Concomitant COPD also prolonged inpatient stay, increases risk of readmission and independently predicts greater financial costs.15-18  

The relationship between HF and COPD is complex. Apart from exposure to cigarette smoke which is a risk factor for both, reduced FEV1 and FEV1/FVC ratio and chronic inflammation as found in COPD are known risk factors for cardiovascular disease (CVD) that is independent of smoking habit. In addition, HF leads to the elaboration of multiple cytokines has adverse effects on the respiratory system in addition to the pooling of blood in the lungs from the congestion of HF leading to inefficient gas exchange. Regardless of the potential mechanisms underlying the combination, current estimates of COPD in HF is worrisome and underscores the need for greater physician awareness to prevent avoidable mortality. Most of the studies available are from USA and Europe. In Nigeria, local studies on co-morbid COPD and outcomes in HF are not available hence the need to carry out this research. Heart failure is a common cause of death among adults in Nigeria, an unknown amount of these patients has a coexisting undiagnosed airflow limitation disorder leading to increased mortality. At JUTH, we have a large pool of patients in HF. About 200-300 patients attend the Cardiology clinic every week about a quarter of who are in HF. Similarly, there are 15-30 patients in HF in the medical wards at most points in time. HF is also one of the commonest indications for admissions from the emergency in our setting.

Patients and Methods:

This study will be in 2 stages. An initial cross- sectional study will recruit 100 adults with Heart failure confirmed by Echocardiography over a 6 months period (recruited from medical wards and clinics) and a later follow-up cohort study of endpoints (hospitalization or mortality) over a 12 months period.

Relevant history, physical examination (body mass index and detailed cardiovascular examination to identify cardiovascular co-morbidities) and blood specimen (for fasting plasma glucose, lipids, E/U/Cr,UA NTBNP) will be obtained from the subjects. Also each will have spirometry (for COPD staging), electrocardiography and echocardiography (to confirm HF) done and data filled into an interviewer administered questionnaire. Berlin’s questionnaire will also be administered to determine presence of OSA. The prevalence of co-morbid Airflow limitation (defined in this study as COPD according to GOLD staging, Restrictive Lung disease and Obstructive sleep apnea as defined by Berlin’s system) and associated risk factors (defined in this study as smoking, obesity, diabetes mellitus, hypertension, hyperuriceamia, chronic kidney disease and hyperlipideamia) will be determined in the first stage. HF in this study will be defined as any patient who meets the Framingham’s criteria for the diagnosis of HF and is confirmed by echocardiography (preserved and reduced ejection fraction) . Participants who are Adults and above in NYHA class 1, 2 or 3 with HF with normal or reduced ejection fraction.

The cohort stage will involve following up each participant (monthly phone calls and during clinic visits) for 12 months and documenting health related outcomes (in this study hospitalizations and death) during this period.

Statistical analysis: Data will be entered into and analyzed using the computer program Epi-Info, version 7.2. Continuous variables will be summarized using mean and standard deviation. Categorical variables will be summarized with percentages in each category. Prevalence will be expressed as a proportion with 95% CI.

Student’s t test will be used to determine the relationship between means of two groups while Fisher’s exact test will be used for categorical variables.

The relationship between HF, COPD, associated factors and hospitalizations and mortality will be determined using cox proportional hazard models. 

Multivariate logistic regression analysis will be done to determine the associations between heart failure, categories of respiratory impairment and associated factors/predictors of hospitalization and mortality. These will be adjusted for age, sex, smoking status and BMI. Significance will be defined as p value less than 0.05.

 

NIH FORM BIOGRAPHICAL SKETCH

 

 

NAME

Amusa Ganiyu Adeniyi

POSITION TITLE

Consultant Physician/ Cardiologist

eRA COMMONS USER NAME (credential, e.g., agency login)

drganiamusa

EDUCATION/TRAINING 

INSTITUTION AND LOCATION

DEGREE

(if applicable)

MM/YY

FIELD OF STUDY

Olabisi Onabanjo University, Ogun State Nigeria. Nigeria

MBChB

05/2004

Medicine & Surgery

 

 

 

 

National Postgraduate Medical College of Nigeria. Nigeria

FMCP

11/2013

Internal Medicine (Cardiology)

 

 

 

 

West African College of Physicians. Ibadan Nigeria.

FWACP

04/2014

Internal Medicine (Cardiology)
         

 

A.        Personal Statement

 

I am a Physician, who has worked in different levels of the Nigeria health care system over the last 12 years and is currently a consultant Physician/Cardiologist at the Jos University Teaching Hospital, Jos; Nigeria. My research interests include the estimation of the burden of cardiovascular disease in sub-Saharan Africa, cardiovascular co-morbidities in chronic diseases as HIV/AIDS, Diabetes, COPD e.t.c. emergency medicine, critical care and translational medicine.

I have completed and passed two dissertations (Cardiovascular Abnormalities in HIV-infected Adults in JUTH and Left Ventricular dysfunction in type2 diabetics in JUTH).

I have a strong passion for research and have participated in several international studies with my mentors as a Research Physician in the Jos University Teaching Hospital site for the REMEDY and  RhGEN studies (on Rheumatic Heart Diseases) and co-PI for the INVICTUS study. I am also a co-PI for the SIREN study JUTH site and is currently the PI for the Burden and Outcomes of co-morbid Cardiovascular diseases in COPD (a MEPIN funded study which i just rounded up).

It is on the basis of learning from senior researchers and my last study ‘Burden and Outcomes of co-mobid Cardiovascular diseases in COPD that have prepared me to lead this present proposed study.    

Research Activities (Ongoing)

  1. Global Registry on Rheumatic Heart Disease (REMEDY Study), JUTH centre. (Research Physician).
  2. Rheumatic Heart Disease Genetic Study (RhGEN Study), JUTH centre. (Research Physician).
  3. Burden and Outcomes of co-morbid Cardiovascular diseases in COPD in North-Central Nigeria. (Primary Investigator, MEPIN Year 05 Mentored Research Grant Award).
  4. Stroke Investigative Research and Education Network (SIREN) Study. (Member, Cardiology Working Group)
  5. Profile of Stroke Patients in JUTH. (STAMINA Research Grant Award, Research Team Member).
  6. Neuropsychiatric manifestations of SLE: A 5 year prospective study. (Research Team Member).

B.        Positions and Honors

Positions & Employment

July 04 - July 05

House Officer, Olabibisi Onabanjo University Teaching Hospital, Sagamu, Nigeria

 

Oct 05 - Aug 06

Medical Officer- National Youth Service Corp. Langtang South LGA Health Department, Plateau State,  Nigeria

Sept 06 - Feb 14

Medical Residency, Internal Medicine, Jos University Teaching Hospital Plateau State Nigeria

Feb 14 - April 14

Consultant Physician/Cardiologist, Federal Medical Center, Keffi, Nasarawa State

 

April 14 - Present

Consultant Physician/ cardiologist, Jos University Teaching Hospital, Plateau State Nigeria

 

Community services

        1. Vice President, Association of Resident Doctors, JUTH.               2010 – 2011.

        2. Editor-In-Chief, Jos Journal of Medicine.                                      2011 – 2013.

        3. Assistant Secretary General, MDCAN, JUTH.                              2014 –

        4. Visiting Consultant Cardiologist, Faith Alive Foundation.              2014 –

        5. Visiting Consultant Cardiologist, Heart Aid Foundation.                2014 –

        6. Chairman, Audit Committee, NMA Plateau.                                  2015-

Honors

  1. NYSC Plateau State Certificate of Merit Award (Governor’s Award), August 2006.
  2. PATS-MECOR Travel Grant Awards to attend PATS-MECOR Conferences in Kenya (2012, 2013, and 2014).
  3. ATS-MECOR Travel Grant Award to attend ATS International Scientific Conference in Denver, Colorado (May, 2014).
  4. University of Jos, MEPIN Research Grant Award (May, 2015)
  5. ATS Travel Grant Award to attend ATS Global MECOR Conference in Istanbul, Turkey (November, 2015). 
  6. ISH Travel Grant Award to attend ISH International Scientific Conference in Seoul, South Korea (September 2016).                                              

C.        Publications

            (a) Selected Articles in Journals

  1. Odili A.N., Amusa G.A. Aortic aneurysm with valvular insufficiency: Is it due to marfan’s syndrome or hypertension? A case report and review of literature. (2011) J Vasc Nurs. 29(1):16-22.
  2. Ukoli C.O., Akanbi M.O., Adiukwu C.V., Amusa G.A., Akanbi F.O. (2012). Diagnosing Tuberculosis in Resource Limited Settings: Experience from a Referral TB Clinic in North-Central Nigeria. Jos Journal of Medicine. 6(1):27-28.
  3. Amusa G.A. Cardiovascular disease: A Global Epidemic extending into Africa. (2012). Jos Journal of Medicine. 6(2):6-12.
  4. Alison Lee, Amusa G.A., et al. (2015). Household air pollution: A call to action. The Lancet Respiratory Medicine. 3:e1-e2.
  5. C.M., Chundusu. G.A., Amusa. Danbauchi S.S., Okeahialam B.N. et al. (2015)  Descriptive evaluation of holter recordings at a teaching hospital in central Nigeria. (2015). Highland Med Res J. 15(2):59-62.
  6. Uguru S.U., Amusa G.A., Okeahialam B.N. et al. (2015) Idiopathic Calcific Constrictive Pericarditis: An Unsettling Reality. Jos Journal of Medicine. 2015;9(3):37-40.

         

 

(b) Selected Papers presented at Conferences

  1. Amusa G.A. Odili A.N. (2008). Marfan’s Syndrome: A case report presented at The Nigerian Cardiac Society 37th AGM and Scientific Conference, Jos, Plateau state.
  2. Amusa G.A., Danbauchi S.S., Okeahialam B.N., et al. (2015). Cardiovascular Disease Risk Factors in HIV-infected Adult Patients in North-Central Nigeria; (Poster Presentation). ATS International Scientific Conference, Denver, Colorado, USA; May 2015.
  3. Amusa G.A., Danbauchi S.S., Okeahialam B.N., et al. (2016). Electrocardiographic Abnormalities in HIV-infected Adult Patients in North-Central Nigeria; (Accepted for Poster Presentation). ATS International Scientific Conference, San Francisco, California, USA; May 2016.
  4. Amusa G.A., Danbauchi S.S., Okeahialam B.N.,  et al. (2016). Echocardiographic Abnormalities in HIV-infected Adult Patients in North-Central Nigeria; (Accepted for Poster Presentation). ATS International Scientific Conference, San Francisco, California, USA; May 2016.
  5. Amusa G.A., Danbauchi S.S., Okeahialam B.N.,  et al. (2016). Left Ventricular Dysfunction in Asymptomatic Hypertensive Patients with and without Type 2 Diabetes: Prevalence, Patterns and Associated Factors. (Accepted for Poster Presentation). ISH International Scientific Conference, Seoul, South Korea. September 2016.
  6. Amusa G.A., Danbauchi S.S., Okeahialam B.N.,  et al. (2016). Hypertension in HIV infected Adults in North Central Nigeria: Prevalence, Associated Risk factors and Assessment of Risk using the Framingham Risk Score (Accepted for Oral Presentation). ISH International Scientific Conference, Seoul, South Korea. September 2016.

 D.       Research Support

  1. University of Jos, MEPIN Research Grant Award (May, 2015)

 

 

BUDGET

 

PROPOSED BUDGET FOR THE STUDY:

ITEM                            QUANTITY   FREQUENCY    UNIT COST(N)  TOTAL COST(N)

 Personnel:

  Research Assistant                   1             18 months             10,000               180,000

Materials and supplies:

  Sample bottles                       150           1/ Subject                100                  15,000          

  Syringes and needles            150           1/ Subject                20                     3,000           

Papers                                       4rims                                       2000                 8000

Laboratory Investigations:

  Lipid profile assay                100                                         1,500                  150,000

  Fasting blood sugar               100                                         200                    20,000

Serum E/U/Cr/Uric acid          100                                          2000                  200,000

NTBNP                                    100                                          1000                  100,000

Radiology:

  Spirometry                             100                                          5,000                 500,000

  Electrocardiography              100                                          1000                  100,000

  Echocardiography                 100                                           5600                  560,000  

Phone Calls                                                                                                       14,000

Statistician Fees                                                                                               70,000

Publication in High Impact Journal                                                              80,000

GRAND TOTAL                                                                                            2,000,000

 

GRAND TOTAL= N2,000,000 (TWO MILLION NAIRA ONLY)

 

BUDGET JUSTIFICATION

Principal Investigator: Amusa Ganiyu Adeniyi

Project title: Burden and Outcomes of co-morbid Airfow limitation disorders in Heart failure.

Personnel:

Mentors (Prof B.N Okeahialam): Will provide scientific support and supervision throughout the duration of the research. No salary requested.

Mentor (Dr Akanbi Maxwell Oluwole); Will provide scientific and statistical support throughout the duration of the research. No salary requested.

Dr Amusa G Adeniyi: Will oversees all aspects of the research - protocol design, recruitment, data collection, analysis and interpretation of results. No salary requested

Co- Investigators (Dr Onuh James, Dr Uguru Samuel): Will be involved in recruitment, data collection, analysis and interpretation of results. No salary requested

Statistician: Will be responsible for the statistical analysis of the research data.

Research Assistant: Will coordinate research logistics, patient recruitment, data collection and laboratory investigations.

Others:  

Universal bottles: These will be used to collect the blood samples for fasting sugar and lipid profile.

Syringe and needles: These will be used to collect venous blood from the participants.

Lipid profile assay: This will determine the presence of abnormal cholesterol and triglyceride levels for the participants, a risk factor for cardiovascular disease

Fasting blood sugar assay: This will determine the presence of hyperglycemia, another risk factor for cardiovascular disease

E/U/Cr/UA- This will determine the presence of hyperuricaemia and CKD, another risk factor for cardiovascular disease

NTBNP- Useful in diagnosis and evaluating severity of HF.

Spirometry: This will enable diagnosis and staging of COPD (GOLD staging system).

Electrocardiography: This will enable diagnosis of atrial fibrillation, ischeamic heart diseases cardiomegally e.t.c

Echocardiography: This will enable diagnosis of heart diseases such as heart failure, cardiomyopathy, ischeamic heart diseases, cor-pulmonale e.t.c.

Publication costs: Research findings will be published in a peer- reviewed journal.

PROJECT NARRATIVE

The availability of funds to conduct this research will provide information about the prevalence of co-morbid airflow limitation (COPD, Restrictive lung disease and OSA) and outcomes in adults with HF. This would serve as a basis for future research on early detection and management of these co-morbidities which has been shown to occur and is associated with increased morbidity and mortality.

RESEARCH PLAN

Specific aims:

  1. To determine the prevalence of co-morbid airflow limitation (COPD, Restrictive lung disease and OSA) in adults with HF.
  2. To determine the prevalence of associated cardiovascular disease risk factors (smoking, obesity, diabetes mellitus, CKD, hyperuriceamia and dyslipidaemia) s in adults with HF.
  3. To determine the relationship of these airflow limitation co-morbidities to health related outcomes (hospitalizations and mortality) in adults with HF over a period of 12 months.

BACKGROUND AND SIGNIFICANCE

Heart failure is one of the few non-communicable diseases whose prevalence has steadily increased over the years. In recent times, there has been an increase in the morbidity and mortality of HF. This alarming trend has been attributed to aging and exponential increase in cardiovascular disease risk factors such as obesity, diabetes, the expanding epidemic of smoking and environmental air pollution globally and an aging world population.

HF is a disease with multiple systemic manifestations and significant co-morbidities. Large population-based studies reports that patients with HF are 2-3 more at risk for concomitant airflow limitation disorder particularly COPD. This has been reported to significantly increase the morbidity and mortality in patients with HF. Apart from exposure to cigarette smoke which is a risk factor for both, reduced FEV1 and FEV1/FVC ratio and chronic inflammation as found in COPD are known risk factors for cardiovascular disease that is independent of smoking habit. In addition, HF leads to the elaboration of multiple cytokines has adverse effects on the respiratory system in addition to the pooling of blood in the lungs from the congestion of HF leading to inefficient gas exchange.  Several observational cohort studies based on health care databases have shown that the classic factors of cardiovascular risk i.e. obesity; diabetes, hypertension, and dyslipidaemia are present more often in patients with HF and concomitant COPD. These same studies have reported that the increase in morbidity and mortality in patients with HF and concomitant COPD. Regardless of the potential mechanisms underlying the combination, current estimates of airflow limitation disorders in HF is worrisome and underscores the need for greater physicians’ awareness.

In Nigeria, local studies on co-morbid COPD and outcomes in HF are not available hence the need to carry out this research. Heart failure is a common cause of death among adults in Nigeria, an unknown amount of these patients has a coexisting undiagnosed airflow limitation disorder leading to increased mortality. At JUTH, we have a large pool of patients in HF. About 200-300 patients attend the Cardiology clinic every week about a quarter of who are in HF. Similarly, there are at least 15-30 patients in HF in the medical wards at most points in time. HF is also one of the commonest indications for admissions from the emergency in our setting.

EXPERIMENTAL DESIGN AND METHODS

This will be a multi-staged study with an initial cross-sectional descriptive stage and a latter cohort stage. Subjects will be recruited from the medical wards and clinics of  Jos University Teaching Hospital (JUTH) in Jos, Plateau state. The laboratory investigations will be carried out at the chemical pathology laboratory of JUTH. Similarly the spirometry, electrocardiography and echocardiography will be carried out at JUTH.

Study subjects:

Consecutive adult patients with HF who consented and meet the selection criteria will be recruited into the study. Informed consent will be obtained from each participant. 

Sample size determination:

The minimum sample size was determined using the formula below:

n = (Z) 2(1-P)(P)

              d 2

Where:

n = minimum sample size

Z = 95% confidence interval = 1.96

P = prevalence of airflow limitation disorders in adults with HF in Nigeria is unknown, 50% will be used

d = precision (absolute error), set at 10% = 0.1

n = (1.96 )2  (1- 0.5) (0.5)

                        (0.1)2

n = 96

This will be rounded up to 100 adults with HF.

Data collection:

Relevant history, physical examination (body mass index and detailed cardiovascular examination to identify cardiovascular co-morbidities) and blood specimen (for fasting plasma glucose, lipids, E/U/Cr and NTBNP) will be obtained from the subjects. Also each will have spirometry (for COPD staging), electrocardiography and echocardiography (to diagnose HF) done and data filled into an interviewer administered questionnaire. The prevalence of co-morbid Airflow limitation (defined in this study as COPD according to GOLD staging, Restrictive Lung disease and Obstructive sleep apnea as defined by Berlin’s system) and associated risk factors (defined in this study as smoking, obesity, diabetes mellitus, hypertension, hyperuriceamia, chronic kidney disease and hyperlipideamia) will be determined in the first stage. The cohort stage will involve following up each participant for 12 months and documenting health related outcomes (in this study hospitalizations and death) during this period.

Ethical Consideration: Ethical clearance will be obtained from the research and ethics committee of the Jos University Teaching Hospital before the study is commenced. Informed consent will be obtained from the participants.

Statistical analysis: An initial one way analysis will be conducted to assess the distribution for each variable. Continuous variables will be summarized using mean and standard deviation. Categorical variables will be summarized with percentages in each category. Prevalence will be expressed as a proportion with 95% CI.

Student’s t test will be used to determine the relationship between means of two groups while Fisher’s exact test will be used for categorical variables.

The relationship between HF, COPD, associated factors and hospitalizations and mortality will be determined using cox proportional hazard models. 

Multivariate logistic regression analysis will be done to determine the associations between heart failure, categories of respiratory impairment and associated factors/predictors of hospitalization and mortality. These will be adjusted for age, sex, smoking status and BMI. Significance will be defined as p value less than 0.05.                                                         

                                                                 

REFERENCES

  1. Murray CJ, Lopez AD. Global mortality, disability, and the contribution of risk factors: Global Burden of Disease Study. Lancet 1997;349:1436–1442.
  2. Murray CJ, Lopez AD. Regional patterns of disability-free life expectancy and disability-adjusted life expectancy: Global Burden of Disease Study. Lancet 1997;349:1347–1352.
  3. Rutten FH, Cramer MJ, Lammers JW, Grobbee DE, Hoes AW. Heart failure and chronic obstructive pulmonary disease: an ignored combination? Eur J Heart Fail 2006;8:706–711.
  4. Barker WH, Mullooly JP, Getchell W. Changing incidence and survival for heart failure in a well-defined older population, 1970–1974 and 1990–1994. Circulation 2006;113:799–805.
  5. Kosiborod M, Lichtman JH, Heidenreich PA, Normand SL, Wang Y, Brass LM, Krumholz HM. National trends in outcomes among elderly patients with heart failure. Am J Med 2006;119:616–617.
  6.  Baker DW, Einstadter D, Thomas C, Cebul RD. Mortality trends for 23,505 Medicare patients hospitalized with heart failure in Northeast Ohio, 1991 to 1997. Am Heart J 2003;146:258–264.
  7. Polanczyk CA, Rohde LE, Dec GW, DiSalvo T. Ten-year trends in hospital care for congestive heart failure: improved outcomes and increased use of resources. Arch Intern Med 2000;160:325–332.
  8. Kitzman DW, Gardin JM, Gottdiener JS, Arnold A, Boineau R, Aurigemma G, Marino EK, Lyles M, Cushman M, Enright PL. Importance of heart failure with preserved systolic function in patients _65 years of age. CHS Research Group. Cardiovascular Health Study. Am J Cardiol 2001;87:413–419.
  9. Ian S Stone, Neil C Barnes, Steffen E Petterson. Chronic obstructive pulmonary disease: a modifiable risk factor for cardiovascular disease? Heart 2012;98:1055-1062.
  10. Hansell AL, Walk JA, Soriano JB. What do chronic obstructive pulmonary disease patients die from? A multiple cause coding analysis. Eur Respir J 2003;22:809–814.
  11. Macchia A, Monte S, Romero M, D’Ettorre A, Tognoni G. The prognostic influence of chronic obstructive pulmonary disease in patients hospitalised for chronic heart failure. Eur J Heart Fail 2007
  12.  Ansari M, Alexander M, Tutar A, Bello D, Massie BM. Cardiology participation improves outcomes in patients with new-onset heart failure in the outpatient setting. J Am Coll Cardiol 2003;41:62–68.
  13. Nathaniel Mark Hawkins, Mark C. Petrie, Pardeep S. Jhund, George W. Chalmers, Francis G. Dunn, and John J.V. McMurray. Heart failure and chronic obstructive pulmonary disease: diagnostic pitfalls and epidemiology. European Journal of Heart Failure (2009) 11, 130–139
  14. Staszewsky L, Wong M, Masson S, Barlera S, Carretta E, Maggioni AP, Anand IS, Cohn JN, Tognoni G, Latini R. Clinical, neurohormonal, and inflammatory markers and overall prognostic role of chronic obstructive pulmonary disease in patients with heart failure: data from the Val-HeFT heart failure trial. J Card Fail 2007;13:797–804.
  15. Harjai KJ, Thompson HW, Turgut T, Shah M. Simple clinical variables are markers of the propensity for readmission in patients hospitalized with heart failure. Am J Cardiol 2001;87:234–237.
  16. Philbin EF, DiSalvo TG. Prediction of hospital readmission for heart failure: development of a simple risk score based on administrative data. J Am Coll Cardiol 1999;33:1560–1566.
  17. Braunstein JB, Anderson GF, Gerstenblith G, Weller W, Niefeld M, Herbert R, Wu AW. Noncardiac comorbidity increases preventable hospitalizations and mortality among Medicare beneficiaries with chronic heart failure. J Am Coll Cardiol 2003;42:1226–1233.
  18. Liao L, Anstrom KJ, Gottdiener JS, Pappas PA, Whellan DJ, Kitzman DW, Aurigemma GP, Mark DB, Schulman KA, Jollis JG. Long-term costs and resource use in elderly participants with congestive heart failure in the Cardiovascular Health Study. Am Heart J 2007;153:245–252.

PLAN FOR PROTECTION OF HUMAN SUBJECTS

The study will involve minimal risk to the participants. Participants found to have co-morbid Airflow limitation disorders with HF will be managed appropriately. The study will also be beneficial to adults with HF that will be managed in the future. Written and informed consent will be obtained from the participants. Information obtained will be safeguarded by entering data without identifiers while the questionnaires will be kept locked up until two years after completion of the study.

IRB APPROVAL

Ethical clearance will be obtained from the JUTH Human Research Ethics Committee for the study.