Effect of Dapagliflozin on Cardiac Structure, Function and Secondary Mitral Regurgitation in Patients with Left Ventricle Dysfunction
Effect of Dapagliflozin on Cardiac Structure in Patients with Left Ventricular Dysfunction
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Banī Suwayf, Egypt
- Beni-Suef University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Control
Group 1 received only standard therapy ACE/ ARB, BB, and diuretics
|
Ramipril 10 mg once daily, carvedilol 6.25 mg twice daily and spironolactone 25 once daily
Other Names:
|
|
Experimental: Interventional
Group 2 received dapagliflozin 10 mg once daily in addition to standard therapy ACE/ ARB, BB, and diuretics
|
Dapagliflozin 10 mg once daily
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Median / Mean of Natriuretic peptide concentration (ProBNP) in serum of patients
Time Frame: 6 months
|
Change in median / mean of ProBNP before and after drug administration
|
6 months
|
|
Median / Mean of Left ventricle Ejection Fraction (LVEF) of patients in patient echocardiographic measures
Time Frame: 6 months
|
Change in median / mean of LVEF before and after drug administration
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ahmed Essam Abou Warda, October 6 University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Genetic Diseases, Inborn
- Cardiomegaly
- Laminopathies
- Cardiomyopathies
- Cardiomyopathy, Dilated
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protease Inhibitors
- Protective Agents
- Natriuretic Agents
- Membrane Transport Modulators
- Diuretics
- Hormone Antagonists
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Sodium-Glucose Transporter 2 Inhibitors
- Antioxidants
- Angiotensin-Converting Enzyme Inhibitors
- Mineralocorticoid Receptor Antagonists
- Diuretics, Potassium Sparing
- Adrenergic alpha-1 Receptor Antagonists
- Adrenergic alpha-Antagonists
- Dapagliflozin
- Spironolactone
- Carvedilol
- Ramipril
Other Study ID Numbers
- IHC00044
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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