A Feasibility Study on Hypertensive Heart Failure TreatmentPhase 4NCT06400784
Hypertensive Heart Failure Treatment in SSA
A Phase 4 study testing Isosorbide Dinitrate in people with A Feasibility Study on Hypertensive Heart Failure Treatment, run by University of Abuja at 1 site in Nigeria.
Trial summary
Even though, the African-American Heart Failure Trial (A- HeFT) demonstrated that a combination ISDN and HYD (BiDil) improved survival among African-American patients with HF, when compared to placebo, there is no trial on chronic heart failure patients secondary to hypertensive heart disease which is the commonest… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- A Feasibility Study on Hypertensive Heart Failure Treatment
- What is being tested?
- Isosorbide Dinitrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteNigeria
- Study dates
- 25 Mar 2022to 26 Mar 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Black male or female aged 18 years
- Evidence of hypertensive heart failure
- LVEF <40% as assessed by 2D echocardiography (modified Simpson method)
- Ability to provide written informed consent for participation in the study
- Available for regular follow-up as outlined in the schedule of assessments
Who cannot join
- Evidence of heart failure from a cause other than hypertension
- A cardiovascular/cerebrovascular event/intervention in the last three months (e.g., acute
- coronary syndrome, unstable angina, MI, PCI, CABG, stroke, carotid endarterectomy, etc.,)
- Office SBP <100 mmHg or DBP <70 mmHg
- Marked renal impairment (e.g., eGFR <45 mls/min at screening, dialysis)
- Marked hepatic impairment (e.g., history of chronic liver disease, γGT/bilirubin/ALP/ALT
- twice the upper limit of normal)
Trial locations and contacts
1 site in 1 country.
Nigeria1 site
University of Abuja Teaching Hospital
Abuja, Federal Capital Territory, 90001
About this study
Official title: The Evidence-based Treatment of Hypertensive Heart Failure in Sub-Saharan Africa: A Feasibility Study
Even though, the African-American Heart Failure Trial (A- HeFT) demonstrated that a combination ISDN and HYD (BiDil) improved survival among African-American patients with HF, when compared to placebo, there is no trial on chronic heart failure patients secondary to hypertensive heart disease which is the commonest etiological factor for heart failure in sub-Saharan Africa.
A previous study (The Bi treatment with hydralazine/nitrate versus placebo in Africans admitted with acute Heart Failure (BAHEF) which was on acute heart failure patients with varying aetiology, was under powered as the study could not achieve the estimated sample size because of logistic issues.
We therefore are trying to determine the feasibility of a randomised, open-label, parallel group, two-arm, superiority trial of ISDN and hydralazine in patients with chronic hypertensive heart failure in sSA.
Read the detailed description
Even though, the African-American Heart Failure Trial (A- HeFT) demonstrated that a combination ISDN and HYD (BiDil) improved survival among African-American patients with HF, when compared to placebo, there is no trial on chronic heart failure patients secondary to hypertensive heart disease which is the commonest etiological factor for heart failure in sub-Saharan Africa.
A previous study (The Bi treatment with hydralazine/nitrate versus placebo in Africans admitted with acute Heart Failure (BAHEF) which was on acute heart failure patients with varying aetiology, was under powered as the study could not achieve the estimated sample size because of logistic issues.
We therefore are trying to determine the feasibility of a randomised, open-label, parallel group, two-arm, superiority trial of ISDN and hydralazine in patients with chronic hypertensive heart failure in sSA. To determine the tolerability of ISDN and hydralazine in sSA.
The secondary objectives on the other hand are:
- To determine fidelity to the trial protocol and CRF by investigators when completing a trial utilising ISDN and hydralazine in patients with chronic hypertensive heart failure in sSA.
- To determine the effect of ISDN-HYD on the following:
- Death and hospitalisation rates
- Changes in office BP
- Changes in 6MWT
- Changes in echocardiographic left ventricular ejection fraction
- Being tested
- Isosorbide Dinitrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isosorbide DinitrateDrug
Isosorbide dinitrate (5mg bd) and Hydralazine (25mg bd) will be added on top of conventional heart failure medications.
| Study group | Role | What they receive |
|---|---|---|
| Conventional HF medications plus ISDN & HYD | Active comparator | Will administer Isosorbide dinitrate (5mg bd) and Hydralazine (25mg bd) on top of conventional heart failure medications. Receives: Drug: Isosorbide Dinitrate |
| Conventional HF medications plus placebo | Placebo comparator | We will administer placebo on top of conventional heart failure medications Receives: Drug: Isosorbide Dinitrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the study
Time taken to recruit the required subjects (n=50)
Measured: 18 months
Secondary outcomes (4)
Clinical Outcomes
Death and hospitalisation rates
Measured: 6 months
Clinical outcomes
Changes in office BP
Measured: 6 months
Clinical outcomes
Changes in 6minute walk test
Measured: 6 months
Clinical outcomes
Changes in echocardiographic left ventricular ejection fraction.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start25 Mar 2022
- Primary completion26 Feb 2024
- Study completion26 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for A Feasibility Study on Hypertensive Heart Failure TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel group, 2-arm, superiority trial.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Abuja
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cambridge
- Responsible party
- Principal investigator, Dr. Dike Ojji, University of Abuja
- Investigators
- REGINA ASUKU, Study director, CARDIOVASCULAR RESEARCH UNIT, UNIVERSITY OF ABUJA TEACHING HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400784
- Sponsor's protocol ID
- Uniabuja
- Other IDs
- G 102642 A18971
- Status last verified
- May 2024
- First submitted
- 31 Dec 2022
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
1. Sliwa K, et al. Readmission and death after an acute heart failure event: predictors and outcomes in sub-Saharan Africa: results from the THESUS-HF registry. Eur Heart J 2013; 34: 3151-59. 2. Cohn JN, et al. A randomized trial of the angiotensin-receptor blocker valsartan in chronic heart failure. N Engl J Med 2001; 345: 1667-75. 3. Lapu-Bula R, et al. From hypertension to heart failure: role of nitric oxide-mediated endothelial dysfunction and emerging insights from myocardial contrast echocardiography. Am J Cardiol 2007; 99: 7D-14D. 4. Taylor AL, et al. Combination of ISDN and hydralazine in blacks with heart failure. N Engl J Med 2004; 351: 2049-57. 5. Carson, P et al. Racial differences in response to therapy for heart failure: analysis of the vasodilator-heart failure trials. Vasodilator-Heart Failure Trial Study Group. J Card Fail 1999: 5; 178-87. 6. Damasceno A, et al. The causes, treatment, and outcome of acute heart failure in 1006 Africans from 9 countries. Arch Intern Med 2012; 172: 1386-94. 7. Sliwa K, et al. Bi treatment with hydralazine/nitrates vs. placebo in Africans admitted with acute HEart Failure (BA-HEF). Eur J Heart Fail 2016; 18: 1248-58.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evidence-based Treatment of Hypertensive Heart Failure in Sub-Saharan Africa: A Feasibility Study
- ClinicalTrials.gov ID
- NCT06400784
- Acronym / sponsor ID
- Uniabuja
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of AbujaUniversity, hospital or other
- Collaborators
- University of Cambridge
- Study start
- 25 Mar 2022 (actual)
- Primary completion
- 26 Feb 2024 (actual)
- Study completion
- 26 Mar 2024 (actual)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Even though, the African-American Heart Failure Trial (A- HeFT) demonstrated that a combination ISDN and HYD (BiDil) improved survival among African-American patients with HF, when compared to placebo, there is no trial on chronic heart failure patients secondary to hypertensive heart disease which is the commonest etiological factor for heart failure in sub-Saharan Africa.
A previous study (The Bi treatment with hydralazine/nitrate versus placebo in Africans admitted with acute Heart Failure (BAHEF) which was on acute heart failure patients with varying aetiology, was under powered as the study could not achieve the estimated sample size because of logistic issues.
We therefore are trying to determine the feasibility of a randomised, open-label, parallel group, two-arm, superiority trial of ISDN and hydralazine in patients with chronic hypertensive heart failure in sSA.
Detailed description
Even though, the African-American Heart Failure Trial (A- HeFT) demonstrated that a combination ISDN and HYD (BiDil) improved survival among African-American patients with HF, when compared to placebo, there is no trial on chronic heart failure patients secondary to hypertensive heart disease which is the commonest etiological factor for heart failure in sub-Saharan Africa.
A previous study (The Bi treatment with hydralazine/nitrate versus placebo in Africans admitted with acute Heart Failure (BAHEF) which was on acute heart failure patients with varying aetiology, was under powered as the study could not achieve the estimated sample size because of logistic issues.
We therefore are trying to determine the feasibility of a randomised, open-label, parallel group, two-arm, superiority trial of ISDN and hydralazine in patients with chronic hypertensive heart failure in sSA. To determine the tolerability of ISDN and hydralazine in sSA.
The secondary objectives on the other hand are:
- To determine fidelity to the trial protocol and CRF by investigators when completing a trial utilising ISDN and hydralazine in patients with chronic hypertensive heart failure in sSA.
- To determine the effect of ISDN-HYD on the following:
- Death and hospitalisation rates
- Changes in office BP
- Changes in 6MWT
- Changes in echocardiographic left ventricular ejection fraction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel group, 2-arm, superiority trial.
| Arm | Type | Receives |
|---|---|---|
| Conventional HF medications plus ISDN & HYD | Active comparator | Drug: Isosorbide DinitrateWill administer Isosorbide dinitrate (5mg bd) and Hydralazine (25mg bd) on top of conventional heart failure medications. |
| Conventional HF medications plus placebo | Placebo comparator | Drug: Isosorbide DinitrateWe will administer placebo on top of conventional heart failure medications |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Black male or female aged 18 years
- Evidence of hypertensive heart failure
- LVEF <40% as assessed by 2D echocardiography (modified Simpson method)
- Ability to provide written informed consent for participation in the study
- Available for regular follow-up as outlined in the schedule of assessments
Key exclusion criteria (7 listed)
- Evidence of heart failure from a cause other than hypertension
- A cardiovascular/cerebrovascular event/intervention in the last three months (e.g., acute
- coronary syndrome, unstable angina, MI, PCI, CABG, stroke, carotid endarterectomy, etc.,)
- Office SBP <100 mmHg or DBP <70 mmHg
- Marked renal impairment (e.g., eGFR <45 mls/min at screening, dialysis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isosorbide DinitrateIsosorbide dinitrate (5mg bd) and Hydralazine (25mg bd) will be added on top of conventional heart failure medications. | Drug | Conventional HF medications plus ISDN & HYD, Conventional HF medications plus placebo |
Primary outcome
Feasibility of the study
Time frame: 18 months
Time taken to recruit the required subjects (n=50)
4 secondary outcomes
Clinical Outcomes
Time frame: 6 months
Clinical outcomes
Time frame: 6 months
Clinical outcomes
Time frame: 6 months
Clinical outcomes
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Background1. Sliwa K, et al. Readmission and death after an acute heart failure event: predictors and outcomes in sub-Saharan Africa: results from the THESUS-HF registry. Eur Heart J 2013; 34: 3151-59. 2. Cohn JN, et al. A randomized trial of the angiotensin-receptor blocker valsartan in chronic heart failure. N Engl J Med 2001; 345: 1667-75. 3. Lapu-Bula R, et al. From hypertension to heart failure: role of nitric oxide-mediated endothelial dysfunction and emerging insights from myocardial contrast echocardiography. Am J Cardiol 2007; 99: 7D-14D. 4. Taylor AL, et al. Combination of ISDN and hydralazine in blacks with heart failure. N Engl J Med 2004; 351: 2049-57. 5. Carson, P et al. Racial differences in response to therapy for heart failure: analysis of the vasodilator-heart failure trials. Vasodilator-Heart Failure Trial Study Group. J Card Fail 1999: 5; 178-87. 6. Damasceno A, et al. The causes, treatment, and outcome of acute heart failure in 1006 Africans from 9 countries. Arch Intern Med 2012; 172: 1386-94. 7. Sliwa K, et al. Bi treatment with hydralazine/nitrates vs. placebo in Africans admitted with acute HEart Failure (BA-HEF). Eur J Heart Fail 2016; 18: 1248-58.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
REGINA ASUKU study director
CARDIOVASCULAR RESEARCH UNIT, UNIVERSITY OF ABUJA TEACHING HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Isosorbide Dinitrate in people with A Feasibility Study on Hypertensive Heart Failure Treatment, run by University of Abuja at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the study (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06400784, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.