Dilated Cardiomyopathy
Conditions
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.
Interventions
DRUGDapagliflozin Farxiga®
Dapagliflozin 10 mg once daily
DRUGRamipril Tritace®, Carvedilol Carvid®,and Spironolactone Aldactone®
Ramipril 10 mg once daily, carvedilol 6.25 mg twice daily and spironolactone 25 once daily
Sponsors
National Heart Institute, Egypt
University of Florida
October 6 University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median / Mean of effective regurgitant orifice area (EROA) of functional mitral regurgitation in patient echocardiographic measures | 6 months | Change in median / mean of EROA before and after drug administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median / Mean of Left ventricle Ejection Fraction (LVEF) of patients in patient echocardiographic measures | 6 months | Change in median / mean of LVEF before and after drug administration |
| Median / Mean of Natriuretic peptide concentration (ProBNP) in serum of patients | 6 months | Change in median / mean of ProBNP before and after drug administration |
Countries
Egypt
Outcome results
None listed