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HEART OF AFRICA projects

The ‘Heart of Soweto Study’ (8000 patients), reporting on the prevalence, presentation and management of cardiac disease in an urban African population was published in the Lancet in 2008 (IF 59, CI 367). This seminal paper led to more than 25 publications describing the impact of HIV/AIDS on CVD (Sliwa. European Heart Journal, 2012), the prevalence of rheumatic heart disease diagnosed in adulthood (Sliwa. European Heart Journal, 2010) and the spectrum of conditions leading to heart failure (Stewart/Sliwa; Circulation 2008). The Heart of Soweto studies included cohort studies in tertiary, secondary and primary care facilities.

Those population studies were expanded (under the umbrella of the ‘Heart of Africa studies’) to other African countries, through the design of several innovative research programs and leveraging of funding. One such study was the THESUS study, which documented the factors contributing to acute heart failure management and outcome in a multi-centre cohort study. A large African team of researchers linked to the Hatter Institute for Cardiovascular Research in Africa continue to perform several other African clinical studies. A few examples are listed below:

RESEARCH COLLABORATORS:  Prof. Karen Sliwa (HICRA), Prof. Mpiko Nsekhe ( Cardiology, UCT), Prof. Albertino Damasceno  and Prof. Ana Mocumbi ( Eduardo Modlane University, Mozambique); Prof. Elija Ogola ( Nairobi, Kenya), Prof. Mahmoud Sani ( Kano, Nigeria), Prof. Dike Ojjii ( Abuja, Nigeria), Dr. Anastase Dzudie ( Douala, Cameroon), Prof. S. Ba ( Dakar, Senegal), Prof. Gad Cotter ( Momentum Research, USA, visiting professor UCT); Prof. Simon Stewart ( Melbourne, Australia, visiting professor, UCT), Prof. Friedrich Thieneman ( UCT & ETH Zurich, Switzerland), Prof Ntobeko Ntusi (UCT Head of Medicine), Prof Gary Maartens (UCT Head of Clinical Pharmacology), Dr Hadiza Saidu Bala (Murtala Muhammad Specialist Hospital, Kano, Nigeria), Prof Pindile Mntla (Sefako Makgatho Health Sciences University), Prof. Rampule Ratsela (University of Limpopo), Dr K Thomas & Dr MB Thomas (Nelson Mandela Academic Hospital, Mthatha), Prof. Makoali Makotoko (University of the Free State - Universitas Hospital)

‘STRONG-HF’ Study in AFRICA

Protocol Identifying Number:  CHF201701              Registry and Number:ClinicalTrials.gov NCT03412201                                                                                                                                                                                           
EudraCT Number: 2018-000486-37 UCT HREC Ref: 479/2018

STRONG-HF is a global, multicentre, randomized, parallel group study designed to evaluate the efficacy and safety of up-titration of standard of care medical therapy including beta-blockers; ACEi, ARB or ARNi; and MRAs, on morbidity and mortality when initiated and up-titrated early during hospitalization for acute heart failure (AHF).                                                                                                   

Primary Objective:  to assess the effects of optimization of medical therapy with beta-blocker; ACEi, ARB or ARNi; and MRAs on 90-day all-cause mortality or heart failure readmission in patients admitted with acute heart failure and clinical and biological signs of congestion. 

Secondary Objectives: is to assess the effect of such intervention on 90-day all-cause mortality, 180-day all-cause mortality, change in quality of life (QoL) as measured by the EQ-5D questionnaire, and 90-day change in NT-proBNP.

STRONG-HF Started enrolling in Africa in November 2018. To date we have enrolled Screened 106 and enrolled 54 patients. The Global target is 900 enrolled participants.

The ADHERENCE Study (Sub-study of the above STRONG-HF study)

Drug concentrations of heart failure medication in plasma, dried blood spots, and/or hair as predictors of clinical outcomes. (ADHERENCE) UCT HREC Ref: 480/2018

In the adherence sub-study, patients enrolled in STRONG-HF and the patients screened for STRONG-HF but have not met the biomarker criteria for persistent congestion will be included (NT-proBNP > 2,500 pg/mL at screening, and NT-proBNP > 1,500 pg/mL at randomization).     

Primary objective: 

To determine if low or undetectable concentrations of carvedilol and enalaprilat/perindoprilat in plasma and DBS predict poor outcomes (combined endpoint of re-admission to hospital and death) in study participants.                                                                  

                                                                                                                                                                

Secondary objectives:  

To determine the proportion of study participants with undetectable or low concentrations of carvedilol and enalaprilat/perindoprilat in plasma and DBS.  

To determine if lower hair concentrations of carvedilol and enalapril/perindopril predict poor outcomes (combined endpoint of re-admission to hospital and death) in study participants. 

The ADHERENCE Sub-study is only conducted in Africa and to date has enrolled 45 participants

Both the STRONG-HF and the ADHERENCE Sub-study are being conducted in the following countries in Africa with Prof Karen Sliwa as the national Leader for South Africa (STRONG-HF) and the Principal Investigator and Study leader for the ADHERENCE Study. Olivia Briton is the Lead Study Coordinator for both studies in Africa. The STRONG-HF study is sponsored by ‘The Heart Initiative’ based in Durham, NC, USA 

 

Nigeria:

Prof Mahmoud Sani             Amino Kano Teaching Hospital, Kano, Kano, Nigeria

Dr Hadiza Saidu                  Murtala Muhammad Specialist Hospital, Kano, Kano, Nigeria

Mozambique:

Prof Albertino Damasceno                 Mavalane General Hospital, Maputo, Mozambique  

Prof Ana Olga Mocumbi                     Maputo Central Hospital, Maputo, Mozambique

South Africa:        

Dr MB Thomas                                      Nelson Mandela Academic Hospital, Mthatha, Eastern Cape

Dr K Thomas                                         Nelson Mandela Academic Hospital, Mthatha, Eastern Cape     

Prof Mpiko Ntsekhe                               University of Cape Town - Groote Schuur Hospital   

Dr Jens Hitzeroth                                  University of Cape Town - Groote Schuur Hospital   

Dr Charle Viljoen                                   University of Cape Town - Groote Schuur Hospital

Global Congestive Heart Failure (G-CHF): A global registry to study the demographics, socioeconomic and clinical factors, aetiologies, pathophysiology, management, barriers to care and outcomes of heart failure patients.

The G-CHF study is a prospective, global, registry study of 20 000 – 25 000 Heart Failure (HF) patients enrolled over 5 years. The Baseline data was obtained on demographic and socioeconomic data, clinical and laboratory variables, echocardiography, HF aetiology, medication use, management patterns, quality of life, barriers to care and health systems. Six-month, 12-month, 18-month and 24-month follow-up data will be obtained to determine changes in management and patient outcomes.

The study in South Africa is presently busy with follow-up and they managed to enrol 111 patients into the main study, which is led by Prof Karen Sliwa as the National Leader together with her Study Coordinator, Olivia Briton.

The Contributing Investigators in South Africa are: Prof Mpiko Ntsekhe (Groote Schuur Hospital, Cape Town), Dr MB Thomas (Nelson Mandela Academic Hospital, Mthatha), Prof EM Makotoko (Universitas Hospital, Bloemfontein) Prof Pindile Mntla (Dr George Mukhari Hospital, Ga-Rankuwa, Gauteng) and Prof Rampule Ratsela (Polokwane Pietersburg Hospital, Pietersburg)

To date there have been 22,135 patients enrolled globally since20 December 2016. The initial target for recruitment completion was 2021; however, PHRI stopped main study (only) recruitment prematurely at the end of 2018 because they were hugely successful in recruiting so many patients in such a small amount time. A wonderful accomplishment.

The Pan African Pulmonary Hypertension Cohort (PAPUCO) Study

The main objective of this research is to describe the epidemiology of pulmonary hypertension (PHT) in patients from a number of African countries. The study has recently be published: Prevalence and predictive value of electrocardiographic abnormalities in pulmonary hypertension: evidence from the Pan-African Pulmonary Hypertension Cohort (PAPUCO) study (Cardiovasc J Afr. 2017 Nov/Dec 23;28(6):370-376 and The causes, treatment, and outcome of pulmonary hypertension in Africa: Insights from the Pan African Pulmonary Hypertension Cohort (PAPUCO) Registry (Int J Cardiol. 2016 Oct 15;221:205-11)

Pulmonary hypertension (PH) is a condition of varying aetiologies that is primary characterised by narrowing of the pulmonary vasculature and consequential right heart failure (RHF). It is a devastating, progressive disease associated with increasingly debilitating symptoms and a poor prognosis. However, the majority of reports emanate from high-income countries. Based on the hypothesis that the underlying pathways to this deadly condition in Africa would be many and varied and produce a high burden of disease (relative to high-income countries), we initiated the Pan African Pulmonary Hypertension Cohort (PAPUCO) Registry Study; a unique study in the African context. The study provides prospective, standardised profiling and outcome data (including 6-month survival profiles) in a series of consecutive African patients newly diagnosed with PH from participating centres across the African continent. Our data provide new insights into PH from a developing world perspective; with clear opportunities to improve its prevention, treatment and outcomes taking into account the relative lack of health resources and the particular need to provide practical guidelines for its rapid detection and optimal management in the African context.

 

B-A-HEF STUDY

Recent research in cardiovascular disease in African populations (Heart of Soweto Study), specifically of heart failure (THESUS Study – Damasceno et al. The causes, treatment and outcome of acute heart failure  in 1006 Africans from 9 countries. Arch Intern Med, 2012), has shown that heart failure is not treated optimally in Africa.  Prof Sliwa has been the principal investigator of a prospective, placebo-controlled, double-blind, randomized study to compare treatment with Hydralazine-Isosorbide–Dinitrate (HYIS) versus placebo on top of standard care in African patients admitted with Acute Heart Failure (AHF) and left ventricular dysfunction - the BA-HEF study. This study commenced in January 2013 and the results were reported at the European Cardiac Society meeting in Florence, Italy in May 2016, and simultaneously published in the European Journal of Heart Failure. The use of different medications such as ACEi and hydralazine/nitrates, has never been examined in patients admitted with acute heart failure. The BA-HEF trial demonstrated challenges in recruiting the expected number of patients with acute heart failure in several African countries, thus highlighting the need for strategic logistic support.

 

 

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