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

Last updated: October 14, 2024
Sponsor: October 6 University
Overall Status: Completed

Phase

3

Condition

Congestive Heart Failure

Heart Disease

Cardiovascular Disease

Treatment

Dapagliflozin Farxiga®

Ramipril Tritace®, Carvedilol Carvid®,and Spironolactone Aldactone®

Clinical Study ID

NCT05849766
IHC00044
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Current use or prior use of Dapagliflozin

  • Current acute heart failure or prior admission with acute decompensated heartfailure 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

Study Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: Dapagliflozin Farxiga®
Phase: 3
Study Start date:
April 27, 2023
Estimated Completion Date:
September 01, 2024

Study 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.

Connect with a study center

  • Beni-suef University

    Banī Suwayf,
    Egypt

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.