Heart FailureNCT06641284
Gender-Based Differences in Heart Failure Hospitalizations Among Patients With Heart Failure Treated With Spironolactone
An observational study of Heart Failure and Heart Failure With Reduced Ejection Fraction, run by Ahmad Abdullah Salawi at 1 site in Saudi Arabia.
Trial summary
Aldosterone antagonists or mineralocorticoid receptor antagonists (MRAs) are used as therapeutic agents for the management of HF with reduced ejection fraction (HFrEF). Gender-related differences have been described in the regulation of the renin-angiotensin-aldosterone system (RAAS), which is at the core of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Heart Failure With Reduced Ejection Fraction, Heart Failure NYHA Class II
- What is being tested?
- Spironolactone
- How many people
- 509 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Oct 2023to 15 Oct 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult (≥ 18 years) ambulatory patients of both sexes with a diagnosis of HFrEF (LVEF≤ 40%) and NYHA class II-IV under optimized medical therapy who are presented to the outpatient clinic and started spironolactone at the time of enrollment.
Who may be able to join
- All adult (≥ 18 years) ambulatory patients of both sexes with a diagnosis of HFrEF (LVEF≤ 40%) and NYHA class II-IV under optimized medical therapy who are presented to the outpatient clinic and started spironolactone at the time of enrollment.
Who cannot join
- Pregnancy or breastfeeding
- 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 transplantation
- Concomitant administration of potent CYP3A inhibitors
- Concomitant administration of potassium supplements or potassium-sparing diuretics
- Disorders of the adrenal glands (such as Addison disease).
- Patients who used MRA in the last 2 weeks before enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gender-Based Differences in Heart Failure Hospitalizations Among Patients With Heart Failure With Reduced Ejection Fraction Treated With Spironolactone: A Prospective Cohort Study
Aldosterone antagonists or mineralocorticoid receptor antagonists (MRAs) are used as therapeutic agents for the management of HF with reduced ejection fraction (HFrEF). Gender-related differences have been described in the regulation of the 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 the RAAS, even though studies have suggested that androgens may increase the RAAS pathway. There are conflicting results because many clinical trials were not specifically designed to investigate gender differences.
Read the detailed description
The RALES trial investigated the effect of spironolactone on symptomatic HF patients without any difference in treatment benefits between both genders. However, only 30 % of the patients enrolled were females. Another trial investigated the gender-based differences in the treatment of HFpEF patients with spironolactone. The results showed no significant sex differences in clinical endpoints, but a substantial reduction in all-cause mortality was associated with spironolactone use in females but not in males. The utilization of HF pharmacotherapy has been controversial, given recent discoveries presented by the PARAGON-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
- Being tested
- Spironolactone
- Keywords
- Heart Failure, Gender, Spironolactone
- 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.
SpironolactoneDrug
All patients will receive Spironolactone as a part of their GDMT for Heart Failure
| Study group | Role | What they receive |
|---|---|---|
| The Female Group | Patients identified themselves as females (Apparent gender) Receives: Drug: Spironolactone | |
| The Male Group | Patients identified themselves as males (Apparent gender) Receives: Drug: Spironolactone |
What is being measured
The primary outcome is the main question the study is designed to answer.
HF Hospitalization
The event of hospitalization due to heart failure.
Measured: 6 months after enrollment
Secondary outcomes (2)
Hospitalization
The event of hospitalization due to any cause.
Measured: 6 months after enrollment
All-cause mortality
The event of mortality 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 posted15 Oct 2024
- Study start1 Oct 2023
- Primary completion15 Oct 2024
- Study completion15 Oct 2024
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.
- 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
- 509 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmad Abdullah Salawi
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Ahmad Abdullah Salawi, University of Jazan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06641284
- Sponsor's protocol ID
- 2460
- Status last verified
- Mar 2025
- First submitted
- 11 Oct 2024
- Last updated
- 24 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gender-Based Differences in Heart Failure Hospitalizations Among Patients With Heart Failure With Reduced Ejection Fraction Treated With Spironolactone: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06641284
- Acronym / sponsor ID
- 2460
- 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, Gender, Spironolactone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 509 participants (actual)
- Lead sponsor
- Ahmad Abdullah SalawiOther government
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 15 Oct 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.
Aldosterone antagonists or mineralocorticoid receptor antagonists (MRAs) are used as therapeutic agents for the management of HF with reduced ejection fraction (HFrEF). Gender-related differences have been described in the regulation of the 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 the RAAS, even though studies have suggested that androgens may increase the RAAS pathway. There are conflicting results because many clinical trials were not specifically designed to investigate gender differences.
Detailed description
The RALES trial investigated the effect of spironolactone on symptomatic HF patients without any difference in treatment benefits between both genders. However, only 30 % of the patients enrolled were females. Another trial investigated the gender-based differences in the treatment of HFpEF patients with spironolactone. The results showed no significant sex differences in clinical endpoints, but a substantial reduction in all-cause mortality was associated with spironolactone use in females but not in males. The utilization of HF pharmacotherapy has been controversial, given recent discoveries presented by the PARAGON-HF trial.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Female Group | – | Drug: SpironolactonePatients identified themselves as females (Apparent gender) |
| The Male Group | – | Drug: SpironolactonePatients identified themselves as males (Apparent gender) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult (≥ 18 years) ambulatory patients of both sexes with a diagnosis of HFrEF (LVEF≤ 40%) and NYHA class II-IV under optimized medical therapy who are presented to the outpatient clinic and started spironolactone at the time of enrollment.
Key inclusion criteria (1 listed)
- All adult (≥ 18 years) ambulatory patients of both sexes with a diagnosis of HFrEF (LVEF≤ 40%) and NYHA class II-IV under optimized medical therapy who are presented to the outpatient clinic and started spironolactone at the time of enrollment.
Key exclusion criteria (8 listed)
- Pregnancy or breastfeeding
- 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 transplantation
- Concomitant administration of potent 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 |
|---|---|---|
| SpironolactoneAll patients will receive Spironolactone as a part of their GDMT for Heart Failure | Drug | The Female Group, The Male Group |
Primary outcome
HF Hospitalization
Time frame: 6 months after enrollment
The event of hospitalization due to heart failure.
2 secondary outcomes
Hospitalization
Time frame: 6 months after enrollment
All-cause mortality
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 24 Mar 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ahmad Abdullah Salawi at 1 site in Saudi Arabia.
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 8 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 24 Mar 2025. 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 Saudi Arabia. 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?
HF Hospitalization (time frame: 6 months after enrollment). 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 24 Mar 2025.