CompletedPhase 3
Effect of Dapagliflozin on Cardiac Structure, Function and Secondary Mitral Regurgitation in Patients with Left Ventricle Dysfunction
Key facts
- Who runs it
- October 6 University
- Where
- Egypt1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- Phase
- Phase 3
- People taking part
- 150 people enrolled
- Started
- 27 Apr 2023
- Ended
- 1 Sept 2024
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Dapagliflozin Farxiga®
- Ramipril Tritace®, Carvedilol Carvid®,and Spironolactone Aldactone®
- Record updated
- 16 October 2024
Who can take part
- Age
- 18 years to 80 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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)
Who cannot take part
- 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
- History of allergy to Dapagliflozin
- Chronic renal impairment with GFR < 30 mL/min/1.73m2
- NYHA functional class IV
- Pregnant or lactating women
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- ControlPlacebo, for comparison
Group 1 received only standard therapy ACE/ ARB, BB, and diuretics
Treatment: Ramipril Tritace®, Carvedilol Carvid®,and Spironolactone Aldactone®
- InterventionalTreatment being tested
Group 2 received dapagliflozin 10 mg once daily in addition to standard therapy ACE/ ARB, BB, and diuretics
Treatment: Dapagliflozin Farxiga®
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effect of Dapagliflozin on Cardiac Structure in Patients with Left Ventricular Dysfunction
- Record updated
- 16 October 2024