Status:
UNKNOWN
Empagliflozin Versus Placebo on the Rate of Arrhythmic Events in Heart Failure Patients
Lead Sponsor:
Rambam Health Care Campus
Collaborating Sponsors:
Boehringer Ingelheim
Conditions:
Heart Failure
Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Empagliflozin treatment in high cardiovascular risk patients has been shown to have a relatively rapid powerful capability in reducing cardiovascular mortality. Among the suggested mechanisms mediatin...
Detailed Description
Background and rationale: Empagliflozin is an orally available inhibitor of the sodium-glucose co-transporter 2 (SGLT-2), that promotes enhanced glucose excretion in the urine, thereby lowering blood ...
Eligibility Criteria
Inclusion
- Heart failure patients with reduced ejection fraction (EF≤40%) as assessed by echocardiographist least 6 months prior to recruitment and NYHA Class≥2
- Patients implanted with ICD, CRTD/S or CRTP devices that are capable of recording the PVC burden and implanted ≥ 2 months prior to recruitment.
- High risk for arrhythmic events at baseline identified by either PVC burden ≥0.5% or ≥2 events of non sustained VT or ≥1 event of sustained ventricular tachycardia or need for anti-tachycardia pacing or defibrillation therapy, during a period of 2 months prior to recruitment.
- Diagnosis of type 2 diabetes mellitus prior to informed consent
- HbA1c≥7% and ≤12%.
- Signed and dated written informed consent by date of Visit 1 in accordance with GCP legislation
- \-
Exclusion
- Evidence of ICD malfunction.
- Past exposure to SGLT2 inhibitors.
- Uncontrolled diabetes with HbA1c\>12% or glucose \>240 mg/dL after an overnight fast.
- Liver abnormalities defined by serum levels of alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase above 3 x upper limit of normal.
- Planned cardiac procedure within 3 months.
- Prior MI in the last 40 days.
- Calculated eGFR\< 45ml/min/1.73m2 as determined by the MDRD formula GFR (mL/min/1.73 m2) = 175 × (Scr)-1.154 × (Age)-0.203 × (0.742 if female) × (1.212 if African American)
- BMI\>50
- Medical History of active cancer in the last 2 years. Exceptions include the following: Basal cell carcinoma of the skin, Squamous cell carcinoma of the skin, Carcinoma in situ of the cervix, Carcinoma in situ of the breast, Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b).
- History of recurrent UTIs or genital infections
- Systolic blood pressure\< 90 mmHg.
- Alcohol or drug abuse within 3 months of informed consent.
- Pre-menopausal women (last menstruation \<+ 1 year prior to informed consent) who:
- \- are nursing or pregnant or
- \- are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems, oral, implantable or injectable contraceptives, sexual abstinence, double barrier method and vasectomised partner.
- Intake of an investigational drug in another trial within 30 days prior to intake of study medication in this trial or participating in another trial involving an investigational drug and/or follow-up
- \-
Key Trial Info
Start Date :
February 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2020
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT03271879
Start Date
February 15 2018
End Date
June 1 2020
Last Update
January 25 2018
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