Effect of Dapagliflozin on Secondary Mitral Regurgitation

Dilated Cardiomyopathy Clinical Trial

Official title:

Effect of Dapagliflozin on Secondary Mitral Regurgitation in Patients With Left Ventricular Dysfunction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05849766
• Other study ID #: IHC00044
• Status: Recruiting
• Phase: Phase 3
• Start date: April 27, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: May 2023
• Source: October 6 University
• Contact: Ahmed Essam Abou Warda, MSc
• Phone: +201007647696
• Email: ahmed.essam[@]o6u.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 ß-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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Dilated Cardiomyopathy
• Mitral Valve Insufficiency

Intervention

Drug:
• Dapagliflozin Farxiga®
Dapagliflozin 10 mg once daily
• Ramipril Tritace®, Carvedilol Carvid®,and Spironolactone Aldactone®
Ramipril 10 mg once daily, carvedilol 6.25 mg twice daily and spironolactone 25 once daily

Locations

Country	Name	City	State
Egypt	Beni-suef University	Bani Suwayf

Sponsors (3)

Lead Sponsor	Collaborator
October 6 University	Beni-Suef University, National Heart Institute, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median / Mean of effective regurgitant orifice area (EROA) of functional mitral regurgitation in patient echocardiographic measures	Change in median / mean of EROA before and after drug administration	6 months
Secondary	Median / Mean of Natriuretic peptide concentration (ProBNP) in serum of patients	Change in median / mean of ProBNP before and after drug administration	6 months