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OpenTrials
Completed

NCT Number: NCT05849766

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beni-suef University

Banī Suwayf, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dapagliflozin Farxiga®

Drug

Dapagliflozin 10 mg once daily

Other names: Forxiga

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

Drug

Ramipril 10 mg once daily, carvedilol 6.25 mg twice daily and spironolactone 25 once daily

Other names: Tritace, Carvid, Aldactone

Primary outcomes

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

    Time frame: 6 months

    Change in median / mean of EROA before and after drug administration

Secondary outcomes

  1. Median / Mean of Left ventricle Ejection Fraction (LVEF) of patients in patient echocardiographic measures

    Time frame: 6 months

    Change in median / mean of LVEF before and after drug administration

  2. Median / Mean of Natriuretic peptide concentration (ProBNP) in serum of patients

    Time frame: 6 months

    Change in median / mean of ProBNP before and after drug administration

Sponsors and collaborators

Lead sponsor

October 6 University

Other

Collaborators

  • National Heart Institute, Egypt
  • University of Florida

Registry information

Official study title

Effect of Dapagliflozin on Cardiac Structure in Patients with Left Ventricular Dysfunction

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 9, 2023
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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