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Clinical Trial Details

Trial ID: L4961
Source ID: NCT03271879
Associated Drug: Empagliflozin At A Dose Of 10 Mg/Day
Title: Empagliflozin Versus Placebo on the Rate of Arrhythmic Events in Heart Failure Patients
Acronym: ERA-HF
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Heart Failure|Diabetes Mellitus|Arrythmia
Interventions: DRUG: Empagliflozin at a dose of 10 mg/day
Outcome Measures: Primary: The primary endpoint is the burden of premature ventricular complexes, defined as the PVCs percentage of all beats in a pre-specified period captured on ICD or CRTD/P device, PVCs burden is defined as the PVCs percentage of all beats in a pre-specified period captured on ICD or CRTD/P device. The change in PVC burden between time on treatment arm versus time on placebo will be calculated and serve as the primary endpoint., Time frames include the time frame between visit 2 (on day 56) and visit 3 (on day 112) and that between visit 4 (on day 140) to visit 5 (on day 196)- each period between visits 2 and 3 and visit 4 and 5 contain a time frame of 56 days | Secondary: Non-sustained ventricular tachycardia (NSVT), This is defined as the number of sustained ventricular tachycardia, and/or ventricular fibrillation, and/or tachycardia pacing (ATP) and/or delivery of shock therapy. All the four parameters will be captured on ICD or CRTD/P device interrogation. Sustained VT and NSVT will be captured as a backup information (in case of ICD or CRTD/P malfunction) on Holter ECG., Time frames include the time frame between visit 2 (on day 56) and visit 3 (on day 112) and that between visit 4 (on day 140) to visit 5 (on day 196)- each period between visits 2 and 3 and visit 4 and 5 contain a time frame of 56 days|NT-Pro-BNP, NT-Pro-BNP Is a plasma level of B-type Natriuretic Peptide used as a blood test for diagnosing and evaluation the presence/severity of heart failure. The change in NT-Pro-BNP will be evaluated as a marker of heart failure severity., Time frames include NT-Pro-BNP measurement on the end of visit 3 (on day 112) versus NT-Pro-BNP level at the end of visit 5 (on day 196).|Left ventricular end diastolic diameter, End diastolic diameter is defined as the cross-sectional diameter of the left ventricle, including the septum and the posterior thicknesses in diastole., Time frames include left ventricular diastolic diameter measured on the end of visit 3 (on day 112) versus that measured at the end of visit 5 (on day 196).|Left ventricular ejection fraction (EF), Ejection fraction is defined as the ratio of the stroke volume to the end-diastolic volume in the left ventricle as performed by echocardiography and expressed by percentage., Time frames include EF measured on visit 3 (on day 112) versus that measured at the end of visit 5 (on day 196).
Sponsor/Collaborators: Sponsor: Rambam Health Care Campus | Collaborators: Boehringer Ingelheim
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 128
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2018-02-15
Completion Date: 2020-06-01
Results First Posted:
Last Update Posted: 2018-01-25
Locations:
URL: https://clinicaltrials.gov/show/NCT03271879