NCT05849766

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: October 6 University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dilated Cardiomyopathy

Interventions

Type	Name	Description
DRUG	Dapagliflozin Farxiga®	Dapagliflozin 10 mg once daily
DRUG	Ramipril Tritace®, Carvedilol Carvid®,and Spironolactone Aldactone®	Ramipril 10 mg once daily, carvedilol 6.25 mg twice daily and spironolactone 25 once daily

Timeline

• Start date: 2023-04-27
• Primary completion: 2024-05-01
• Completion: 2024-09-01
• First posted: 2023-05-09
• Last updated: 2024-10-16

Locations

1 site across 1 country: Egypt