Dilated CardiomyopathyPhase 3NCT05849766
Effect of Dapagliflozin on Cardiac Structure, Function and Secondary Mitral Regurgitation in Patients with Left Ventricle Dysfunction
A Phase 3 study testing Dapagliflozin Farxiga® and Ramipril Tritace®, Carvedilol Carvid®,and Spironolactone Aldactone® in people with Dilated Cardiomyopathy, run by October 6 University at 1 site in Egypt.
Trial summary
A significant reduction in the incidence of CV death or hospitalization for HF has been observed in randomized trials investigating the CV benefit of Dapagliflozin. Mechanistic investigations are required to interpret the positive clinical effects of Dapagliflozin on heart structure and valvular regurgitation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dilated Cardiomyopathy
- What is being tested?
- Dapagliflozin Farxiga® and Ramipril Tritace®, Carvedilol Carvid®,and Spironolactone Aldactone®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Apr 2023to 1 Sep 2024
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients ≥ 18 years of age
- Dilated LV with a reduced ejection fraction and secondary functional MR
- NYHA functional class II or III
- Moderate to Severe MR which lasted > 6 months under medical treatment with a β-blocker and an ACE inhibitor (or ARB)
Who cannot join
- Current use or prior use of Dapagliflozin
- Current acute heart failure or prior admission with acute decompensated heart failure in 6 months before entry to study
- NYHA functional class IV
- Chronic renal impairment with GFR < 30 mL/min/1.73m2
- Pregnant or lactating women
- History of allergy to Dapagliflozin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Dapagliflozin on Cardiac Structure in Patients with Left Ventricular Dysfunction
A significant reduction in the incidence of CV death or hospitalization for HF has been observed in randomized trials investigating the CV benefit of Dapagliflozin. Mechanistic investigations are required to interpret the positive clinical effects of Dapagliflozin on heart structure and valvular regurgitation.
Read the detailed description
A functional mitral regurgitation (MR) occurs when the mitral valve (MV) becomes tethered due to abnormal LV remodelling in individuals with heart failure (HF) and left ventricular (LV) dilatation.
The primary treatment for HF is medical, and it is based on established guidelines, as LV failure is the most common cause of secondary functional MR. Standard medical therapy for patients with functional MR, including beta blockers, ACE inhibitors, and angiotensin receptor blockers (ARB), does not reduce the morbidity or mortality associated with these conditions.
Similar to the neprilysin inhibitor, which promotes sodium excretion and has vasodilatory effects via relaxing blood vessels, Dapagliflozin reduce cardiac preload and afterload by inducing natriuresis and reducing arterial stiffness. Effects on blood pressure reduction and weight loss may also positively affect left ventricular (LV) remodelling.
Using echocardiography, researchers hope to test the hypothesis that dapagliflozin improves MR in patients with functional MR due to LV dysfunction. This hypothesis is based on studies showing the beneficial effects of Dapagliflozin on LV modelling.
- Conditions
- Dilated Cardiomyopathy
- Being tested
- Dapagliflozin Farxiga®, Ramipril Tritace®, Carvedilol Carvid®,and Spironolactone Aldactone®
- Medical subject headings
- Cardiomyopathy, Dilated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin Farxiga®Drug
Also called Forxiga
Dapagliflozin 10 mg once daily
Ramipril Tritace®, Carvedilol Carvid®,and Spironolactone Aldactone®Drug
Also called Tritace, Carvid, Aldactone
Ramipril 10 mg once daily, carvedilol 6.25 mg twice daily and spironolactone 25 once daily
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Group 1 received only standard therapy ACE/ ARB, BB, and diuretics Receives: Drug: Ramipril Tritace®, Carvedilol Carvid®,and Spironolactone Aldactone® |
| Interventional | Experimental | Group 2 received dapagliflozin 10 mg once daily in addition to standard therapy ACE/ ARB, BB, and diuretics Receives: Drug: Dapagliflozin Farxiga® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median / Mean of effective regurgitant orifice area (EROA) of functional mitral regurgitation in patient echocardiographic measures
Change in median / mean of EROA before and after drug administration
Measured: 6 months
Secondary outcomes (2)
Median / Mean of Left ventricle Ejection Fraction (LVEF) of patients in patient echocardiographic measures
Change in median / mean of LVEF before and after drug administration
Measured: 6 months
Median / Mean of Natriuretic peptide concentration (ProBNP) in serum of patients
Change in median / mean of ProBNP before and after drug administration
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 posted9 May 2023
- Study start27 Apr 2023
- Primary completion1 May 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dilated CardiomyopathyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart Institute, Egypt, University of Florida
- Responsible party
- Principal investigator, Ahmed Essam, October 6 University
- Investigators
- Ahmed Essam Abou Warda, Principal investigator, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05849766
- Sponsor's protocol ID
- IHC00044
- Status last verified
- Oct 2024
- First submitted
- 27 Apr 2023
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dapagliflozin on Cardiac Structure in Patients with Left Ventricular Dysfunction
- ClinicalTrials.gov ID
- NCT05849766
- Acronym / sponsor ID
- IHC00044
- Conditions
- Dilated Cardiomyopathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Collaborators
- National Heart Institute, Egypt, University of Florida
- Study start
- 27 Apr 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 9 May 2023 (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.
A significant reduction in the incidence of CV death or hospitalization for HF has been observed in randomized trials investigating the CV benefit of Dapagliflozin. Mechanistic investigations are required to interpret the positive clinical effects of Dapagliflozin on heart structure and valvular regurgitation.
Detailed description
A functional mitral regurgitation (MR) occurs when the mitral valve (MV) becomes tethered due to abnormal LV remodelling in individuals with heart failure (HF) and left ventricular (LV) dilatation.
The primary treatment for HF is medical, and it is based on established guidelines, as LV failure is the most common cause of secondary functional MR. Standard medical therapy for patients with functional MR, including beta blockers, ACE inhibitors, and angiotensin receptor blockers (ARB), does not reduce the morbidity or mortality associated with these conditions.
Similar to the neprilysin inhibitor, which promotes sodium excretion and has vasodilatory effects via relaxing blood vessels, Dapagliflozin reduce cardiac preload and afterload by inducing natriuresis and reducing arterial stiffness. Effects on blood pressure reduction and weight loss may also positively affect left ventricular (LV) remodelling.
Using echocardiography, researchers hope to test the hypothesis that dapagliflozin improves MR in patients with functional MR due to LV dysfunction. This hypothesis is based on studies showing the beneficial effects of Dapagliflozin on LV modelling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: Ramipril Tritace®, Carvedilol Carvid®,and Spironolactone Aldactone®Group 1 received only standard therapy ACE/ ARB, BB, and diuretics |
| Interventional | Experimental | Drug: Dapagliflozin Farxiga®Group 2 received dapagliflozin 10 mg once daily in addition to standard therapy ACE/ ARB, BB, and diuretics |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Outpatients ≥ 18 years of age
- Dilated LV with a reduced ejection fraction and secondary functional MR
- NYHA functional class II or III
- Moderate to Severe MR which lasted > 6 months under medical treatment with a β-blocker and an ACE inhibitor (or ARB)
Key exclusion criteria (6 listed)
- Current use or prior use of Dapagliflozin
- Current acute heart failure or prior admission with acute decompensated heart failure in 6 months before entry to study
- NYHA functional class IV
- Chronic renal impairment with GFR < 30 mL/min/1.73m2
- Pregnant or lactating women
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 |
|---|---|---|
| Dapagliflozin Farxiga®Also: ForxigaDapagliflozin 10 mg once daily | Drug | Interventional |
| Ramipril Tritace®, Carvedilol Carvid®,and Spironolactone Aldactone®Also: Tritace, Carvid, AldactoneRamipril 10 mg once daily, carvedilol 6.25 mg twice daily and spironolactone 25 once daily | Drug | Control |
Primary outcome
Median / Mean of effective regurgitant orifice area (EROA) of functional mitral regurgitation in patient echocardiographic measures
Time frame: 6 months
Change in median / mean of EROA before and after drug administration
2 secondary outcomes
Median / Mean of Left ventricle Ejection Fraction (LVEF) of patients in patient echocardiographic measures
Time frame: 6 months
Median / Mean of Natriuretic peptide concentration (ProBNP) in serum of patients
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 16 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Ahmed Essam Abou Warda principal investigator
October 6 University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dapagliflozin Farxiga® and Ramipril Tritace®, Carvedilol Carvid®,and Spironolactone Aldactone® in people with Dilated Cardiomyopathy, run by October 6 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 4 inclusion and 6 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 16 Oct 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Median / Mean of effective regurgitant orifice area (EROA) of functional mitral regurgitation in patient echocardiographic measures (time frame: 6 months). 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 16 Oct 2024.