CompletedPhase 3

Effect of Dapagliflozin on Cardiac Structure, Function and Secondary Mitral Regurgitation in Patients with Left Ventricle Dysfunction

Egypt150 participantsStarted 2023-04-27

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Median / Mean of effective regurgitant orifice area (EROA) of functional mitral regurgitation in patient echocardiographic measures

Timeframe: 6 months

Trial details

NCT IDNCT05849766

SponsorOctober 6 University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-01

View on ClinicalTrials.gov More Dilated Cardiomyopathy trials