Effect of Dapagliflozin on Secondary Mitral Regurgitation

• Status: Recruiting
• Trial end date: 2024-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: October 6 University
• Collaborators: Beni-Suef University; National Heart Institute, Egypt
• Treatments: Carvedilol; Dapagliflozin; Ramipril; Spironolactone

Criteria

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