Effect of Dapagliflozin on Cardiac Structure, Function and Secondary Mitral Regurgitation in Patients with Left Ventricle Dysfunction
NCT ID: NCT05849766
Last Updated: 2024-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
150 participants
INTERVENTIONAL
2023-04-27
2024-09-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control
Group 1 received only standard therapy ACE/ ARB, BB, and diuretics
Ramipril Tritace®, Carvedilol Carvid®,and Spironolactone Aldactone®
Ramipril 10 mg once daily, carvedilol 6.25 mg twice daily and spironolactone 25 once daily
Interventional
Group 2 received dapagliflozin 10 mg once daily in addition to standard therapy ACE/ ARB, BB, and diuretics
Dapagliflozin Farxiga®
Dapagliflozin 10 mg once daily
Interventions
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Dapagliflozin Farxiga®
Dapagliflozin 10 mg once daily
Ramipril Tritace®, Carvedilol Carvid®,and Spironolactone Aldactone®
Ramipril 10 mg once daily, carvedilol 6.25 mg twice daily and spironolactone 25 once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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National Heart Institute, Egypt
OTHER_GOV
University of Florida
OTHER
October 6 University
OTHER
Responsible Party
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Ahmed Essam
Assistant Lecturer of Clinical Pharmacy
Principal Investigators
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Ahmed Essam Abou Warda
Role: PRINCIPAL_INVESTIGATOR
October 6 University
Locations
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Beni-suef University
Banī Suwayf, , Egypt
Countries
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Other Identifiers
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IHC00044
Identifier Type: -
Identifier Source: org_study_id
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