Heart FailureGBDAL-HFNCT06233695
Gender-based Differences in the Outcome of Treatment With Aldosterone Antagonists in Patients With Heart Failure
An observational study of Heart Failure and Heart Failure With Reduced Ejection Fraction, run by Alexandria University at 1 site in Egypt.
Trial summary
Heart failure (HF) is a major healthcare problem. In patients with Heart Failure with Reduced Ejection Fraction (HFrEF), aldosterone antagonists reduce mortality and hospitalization rate. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Failure, Heart Failure With Reduced Ejection Fraction, Heart Failure NYHA Class II
- What is being tested?
- Potassium sparing diuretic
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2022to 1 Dec 2023
- Phase
- Observational
- 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 to 75 years
- All sexes
- Adult, Older adult
Study population: New York Heart Association (NYHA) class II-IV heart failure with reduced ejection fraction HFrEF patients (LVEF≤ 40%).
Who may be able to join
- The diagnosis of heart failure with reduced ejection fraction HFrEF (LVEF≤ 40%) and New York Heart Association (NYHA) class II-IV under optimized medical therapy who are presented to the outpatient clinic and started an aldosterone antagonist at the time of enrollment.
Who cannot join
- Pregnancy or breast-feeding.
- Serum creatinine > 2.5 mg/dL (221 μmol/L) in males and > 2 mg/dL (177 μmol/L) in women (or estimated glomerular filtration rate eGFR ≤ 30 mL/minute/1.73 m2).
- Hyperkalemia (serum potassium level > 5 mEq/L).
- Renal transplant.
- Concomitant administration of strong CYP3A inhibitors.
- Concomitant administration of potassium supplements or potassium-sparing diuretics.
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- Disorders of adrenal glands (Addison disease).
- Patients who used mineralocorticoid receptor antagonists in the last 2 weeks before enrollment.
- Patients with a history of mineralocorticoid receptor antagonists allergy or intolerance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Gender-Based Differences in the Outcome of Treatment by Aldosterone Antagonists in Patients With Heart Failure
Heart failure (HF) is a major healthcare problem. In patients with Heart Failure with Reduced Ejection Fraction (HFrEF), aldosterone antagonists reduce mortality and hospitalization rate. Gender-related differences have been described in the regulation of renin angiotensin aldosterone system (RAAS), which is at the core of the pathophysiology of HF. Regarding gender-related differences in the use of MRAs, less is known about the effects of androgens on RAAS.
In this single-center prospective cohort, a total of 100 adult (≥ 18 years) ambulatory patients of both sexes with the diagnosis of HF with HFrEF (LVEF≤ 40%) and NYHA class II-IV under optimized medical therapy started an aldosterone antagonist are enrolled and followed-up for 6 months. Patients are categorized according to their apparent sexual gender into two groups: the male group and the female group.
- Conditions
- Heart Failure, Heart Failure With Reduced Ejection Fraction, Heart Failure NYHA Class II, Heart Failure NYHA Class III, Heart Failure NYHA Class IV
- Being tested
- Potassium sparing diuretic
- Keywords
- Heart Failure, Heart Failure with Reduced Ejection Fraction, Gender, Eplerenone, Spironolactone, Hospitalization
- Medical subject headings
- Heart Failure, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Potassium sparing diureticDrug
Starting Spironolactone or Eplerenone at the time of enrollment.
| Study group | Role | What they receive |
|---|---|---|
| The Female Group | Patients with an apparent gender of female. Receives: Drug: Potassium sparing diuretic | |
| The Male Group | Patients with an apparent gender of male. Receives: Drug: Potassium sparing diuretic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart failure hospitalization
The incidence of Hospitalization due to heart failure
Measured: 6 months after enrollment
Acute myocardial infarction
The incidence of acute myocardial infarction
Measured: 6 months after enrollment
Percentage of patients who discontinued mineralocorticoid receptor antagonist
Discontinuation of mineralocorticoid receptor antagonist
Measured: 6 months after enrollment
Switching from one mineralocorticoid receptor antagonist to another
Changing the mineralocorticoid receptor antagonist used
Measured: 6 months after enrollment
Acute Kidney Injury
The incidence of acute kidney injury
Measured: 6 months after enrollment
Adverse effects
The occurrence of Hyperkalemia, hypochloremic alkalosis, dehydration, or MRA adverse effects
Measured: 6 months after enrollment
Secondary outcomes (2)
All-cause hospitalization rate
Hospitalization due to any cause including heart failure
Measured: 6 months after enrollment
All-cause mortality rate
Death due to any cause
Measured: 6 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start15 Oct 2022
- Primary completion15 Jul 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Salah Abdelkader, MSc, Principal investigator, Cardiology Department, Faculty of Medicine, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06233695
- Sponsor's protocol ID
- GBDAL-HF Trial
- Acronym
- GBDAL-HF
- Status last verified
- Jan 2024
- First submitted
- 13 Jan 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Gender-Based Differences in the Outcome of Treatment by Aldosterone Antagonists in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT06233695
- Acronym / sponsor ID
- GBDAL-HF / GBDAL-HF Trial
- Conditions
- Heart Failure, Heart Failure With Reduced Ejection Fraction, Heart Failure NYHA Class II, Heart Failure NYHA Class III, Heart Failure NYHA Class IV
- Keywords
- Heart Failure, Heart Failure with Reduced Ejection Fraction, Gender, Eplerenone, Spironolactone, Hospitalization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 31 Jan 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.
Heart failure (HF) is a major healthcare problem. In patients with Heart Failure with Reduced Ejection Fraction (HFrEF), aldosterone antagonists reduce mortality and hospitalization rate. Gender-related differences have been described in the regulation of renin angiotensin aldosterone system (RAAS), which is at the core of the pathophysiology of HF. Regarding gender-related differences in the use of MRAs, less is known about the effects of androgens on RAAS.
In this single-center prospective cohort, a total of 100 adult (≥ 18 years) ambulatory patients of both sexes with the diagnosis of HF with HFrEF (LVEF≤ 40%) and NYHA class II-IV under optimized medical therapy started an aldosterone antagonist are enrolled and followed-up for 6 months. Patients are categorized according to their apparent sexual gender into two groups: the male group and the female group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Female Group | – | Drug: Potassium sparing diureticPatients with an apparent gender of female. |
| The Male Group | – | Drug: Potassium sparing diureticPatients with an apparent gender of male. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- New York Heart Association (NYHA) class II-IV heart failure with reduced ejection fraction HFrEF patients (LVEF≤ 40%).
Key inclusion criteria (1 listed)
- The diagnosis of heart failure with reduced ejection fraction HFrEF (LVEF≤ 40%) and New York Heart Association (NYHA) class II-IV under optimized medical therapy who are presented to the outpatient clinic and started an aldosterone antagonist at the time of enrollment.
Key exclusion criteria (9 listed)
- Pregnancy or breast-feeding.
- Serum creatinine > 2.5 mg/dL (221 μmol/L) in males and > 2 mg/dL (177 μmol/L) in women (or estimated glomerular filtration rate eGFR ≤ 30 mL/minute/1.73 m2).
- Hyperkalemia (serum potassium level > 5 mEq/L).
- Renal transplant.
- Concomitant administration of strong CYP3A inhibitors.
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 |
|---|---|---|
| Potassium sparing diureticStarting Spironolactone or Eplerenone at the time of enrollment. | Drug | The Female Group, The Male Group |
Primary outcome
Heart failure hospitalization
Time frame: 6 months after enrollment
The incidence of Hospitalization due to heart failure
Acute myocardial infarction
Time frame: 6 months after enrollment
The incidence of acute myocardial infarction
Percentage of patients who discontinued mineralocorticoid receptor antagonist
Time frame: 6 months after enrollment
Discontinuation of mineralocorticoid receptor antagonist
Switching from one mineralocorticoid receptor antagonist to another
Time frame: 6 months after enrollment
Changing the mineralocorticoid receptor antagonist used
Acute Kidney Injury
Time frame: 6 months after enrollment
The incidence of acute kidney injury
Adverse effects
Time frame: 6 months after enrollment
The occurrence of Hyperkalemia, hypochloremic alkalosis, dehydration, or MRA adverse effects
2 secondary outcomes
All-cause hospitalization rate
Time frame: 6 months after enrollment
All-cause mortality rate
Time frame: 6 months after enrollment
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 26 Feb 2024.
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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.
Salah Abdelkader, MSc principal investigator
Cardiology Department, Faculty of Medicine, Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Heart Failure With Reduced Ejection Fraction, run by Alexandria University at 1 site in Egypt.
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 1 inclusion and 9 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 26 Feb 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 Egypt. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Heart failure hospitalization (time frame: 6 months after enrollment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.