The Ibadan Acute and Chronic Heart Failure Project

NCT05936957 | Recruiting

• 2 other identifiers: IHFP_Protocol_V1.2_2015190371
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

Contemporary studies from South Africa and Nigeria have built on historical reports to demonstrate that the etiology and indeed case profile of acute HF (i.e. more women and younger individuals affected in the prime of their life) is different from high-income countries. As such, HF is now responsible for 7-10% of medical admissions in the region. These are entirely based on studies on acute HF and few on chronic HF. The nexus between endemic infections such as tuberculosis (TB) and HIV/AIDS and other non-communicable or non-infectious risk factors and HF in Africa is scarcely documented. This study will assess the long-term outcomes, risk factors, clinical phenotypes, and genomics of HF in Ibadan, Nigeria, estimate catastrophic healthcare cost associated with CHF and how it affects evidence-based care; understand cultural and social conceptions of HF in the city and by extension in Nigeria. Data from each subject shall be obtained using a uniform and standardized case report forms (CRF). A detailed clinical documentation on cases of HF will be undertaken. All variables will be summarized using appropriate descriptive statistics. Means and proportions will be estimated with two-tailed 95% confidence intervals. Specified patients' outcomes will also be summarized using proportions. Factors associated wit patient outcomes will be investigated using multivariable logistic regression models. Crude and adjusted Odds Ratio (OR) with 95% confidence intervals (CI) will be estimated. The primary event outcome of the study will be mortality by cause. Secondary event outcomes will include non-fatal major events (both resulting in and not resulting in admission).

Conditions

Heart Failure

Keywords

Heart failure, Cardiac Failure

Outcome Measures

Primary Outcomes (1)

• Mortality

  All cause mortality

  5 years

Secondary Outcomes (1)

• Hospitalisation

  5 years

Study Arms (2)

Acute heart failure

These are acutely decompensated heart failure

Chronic heart failure

These are stable heart failure patients being followed up in the outpatient clinic

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adults aged 18-100 years presenting with heart failure

You may qualify if:

• All cases of heart failure

You may not qualify if:

• No consent to participate

Sponsors & Collaborators

• University College Hospital, Ibadan: lead

Study Sites (1)

University College Hospital Ibadan

Ibadan, Oyo State, 200212, Nigeria

RECRUITING

Related Publications (7)

• Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. No abstract available. Erratum In: Circulation. 2017 Mar 7;135(10):e646. doi: 10.1161/CIR.0000000000000491. Circulation. 2017 Sep 5;136(10):e196. doi: 10.1161/CIR.0000000000000530.

  PMID: 28122885 RESULT

• Cowie MR, Mosterd A, Wood DA, Deckers JW, Poole-Wilson PA, Sutton GC, Grobbee DE. The epidemiology of heart failure. Eur Heart J. 1997 Feb;18(2):208-25. doi: 10.1093/oxfordjournals.eurheartj.a015223. No abstract available.

  PMID: 9043837 RESULT

• Bui AL, Horwich TB, Fonarow GC. Epidemiology and risk profile of heart failure. Nat Rev Cardiol. 2011 Jan;8(1):30-41. doi: 10.1038/nrcardio.2010.165. Epub 2010 Nov 9.

  PMID: 21060326 RESULT

• Redfield MM, Jacobsen SJ, Burnett JC Jr, Mahoney DW, Bailey KR, Rodeheffer RJ. Burden of systolic and diastolic ventricular dysfunction in the community: appreciating the scope of the heart failure epidemic. JAMA. 2003 Jan 8;289(2):194-202. doi: 10.1001/jama.289.2.194.

  PMID: 12517230 RESULT

• Mosterd A, Hoes AW, de Bruyne MC, Deckers JW, Linker DT, Hofman A, Grobbee DE. Prevalence of heart failure and left ventricular dysfunction in the general population; The Rotterdam Study. Eur Heart J. 1999 Mar;20(6):447-55.

  PMID: 10213348 RESULT

• Damasceno A, Mayosi BM, Sani M, Ogah OS, Mondo C, Ojji D, Dzudie A, Kouam CK, Suliman A, Schrueder N, Yonga G, Ba SA, Maru F, Alemayehu B, Edwards C, Davison BA, Cotter G, Sliwa K. The causes, treatment, and outcome of acute heart failure in 1006 Africans from 9 countries. Arch Intern Med. 2012 Oct 8;172(18):1386-94. doi: 10.1001/archinternmed.2012.3310.

  PMID: 22945249 RESULT

• Ogah OS, Stewart S, Falase AO, Akinyemi JO, Adegbite GD, Alabi AA, Ajani AA, Adesina JO, Durodola A, Sliwa K. Contemporary profile of acute heart failure in Southern Nigeria: data from the Abeokuta Heart Failure Clinical Registry. JACC Heart Fail. 2014 Jun;2(3):250-9. doi: 10.1016/j.jchf.2013.12.005. Epub 2014 Apr 30.

  PMID: 24952692 RESULT

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Okechukwu S Ogah, PhD

  Cardiology Unit, Department of Medicine, University College Hospital Ibadan, Nigeria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Okechukwu S Ogah, PhD

CONTACT

+2348067747121; osogah56156@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: July 10, 2023
• Study Start: January 1, 2015
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2030
• Last Updated: July 10, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1)