Effect of Dapagliflozin on Cardiac Structure in Patients with Left Ventricular Dysfunction
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- October 6 University
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Median / Mean of effective regurgitant orifice area (EROA) of functional mitral regurgitation in patient echocardiographic measures
Study Overview
Brief 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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Control
Group 1 received only standard therapy ACE/ ARB, BB, and diuretics
Intervention: Ramipril Tritace®, Carvedilol Carvid®,and Spironolactone Aldactone® (Drug)
Interventional
Group 2 received dapagliflozin 10 mg once daily in addition to standard therapy ACE/ ARB, BB, and diuretics
Intervention: Dapagliflozin Farxiga® (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Median / Mean of Left ventricle Ejection Fraction (LVEF) of patients in patient echocardiographic measures(6 months)
- Median / Mean of Natriuretic peptide concentration (ProBNP) in serum of patients(6 months)
Investigators
Ahmed Essam
Assistant Lecturer of Clinical Pharmacy
October 6 University