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Clinical trial

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

ID
Name
IHC00044
Description
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.
Trial arms
Trial start
2023-04-27
Estimated PCD
2024-02-01
Trial end
2024-05-01
Status
Recruiting
Phase
Early phase I
Treatment
Dapagliflozin Farxiga®
Dapagliflozin 10 mg once daily
Arms:
Interventional
Other names:
Forxiga
Ramipril Tritace®, Carvedilol Carvid®,and Spironolactone Aldactone®
Ramipril 10 mg once daily, carvedilol 6.25 mg twice daily and spironolactone 25 once daily
Arms:
Control
Other names:
Tritace, Carvid, Aldactone
Size
150
Primary endpoint
Median / Mean of effective regurgitant orifice area (EROA) of functional mitral regurgitation in patient echocardiographic measures
6 months
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}
Updated at
2023-05-09

1 organization

2 products

1 indication

Organization
October 6 University
Product
Dapagliflozin
Indication
Dilated Cardiomyopathy
Product
Ramipril Tritace