Beni-suef University
Banī Suwayf, Egypt
NCT Number: NCT05849766
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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Notify Me18 year–80 year
All sexes
Interventional
Phase 3
Banī Suwayf, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dapagliflozin 10 mg once daily
Other names: Forxiga
Ramipril 10 mg once daily, carvedilol 6.25 mg twice daily and spironolactone 25 once daily
Other names: Tritace, Carvid, Aldactone
Time frame: 6 months
Change in median / mean of EROA before and after drug administration
Time frame: 6 months
Change in median / mean of LVEF before and after drug administration
Time frame: 6 months
Change in median / mean of ProBNP before and after drug administration
October 6 University
Other
Effect of Dapagliflozin on Cardiac Structure in Patients with Left Ventricular Dysfunction
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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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