Phase 2 study to Assess Efficacy & Safety of CDR132L
Research type
Research Study
Full title
Phase 2, Multicenter, Randomized, Parallel, 3-arm, Placebo-controlled Study to Assess Efficacy and Safety of CDR132L in Patients with Reduced Left Ventricular Ejection Fraction (≤ 45%) After Myocardial Infarction (HF REVERT)
IRAS ID
1006514
Contact name
Rahul Agrawal
Contact email
Sponsor organisation
Cardior Pharmaceuticals GmbH
Eudract number
2021-006040-27
Clinicaltrials.gov Identifier
Research summary
The main purpose of this clinical research study is to look at how safe the study drug (CDR132L) is and whether it works when given to people with heart failure after having a heart attack.
The study will also look at how safe the study drug is and the effects of the study drug on heart function by looking at biomarkers. A biomarker is a biological substance found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease.
CDR132L (study drug) is a molecule that works by blocking the action of another molecule called miR-132 in heart muscle cells. In a previous study, various doses of the study drug were tested in people and all doses were found to be safe and well tolerated.
Participants will be randomly assigned to receive the study drug or placebo. A placebo looks the same as the study drug being investigated but contains no actual medication. Participants will be in this study for about 1 year and have approximately 8 visits to the study centre. The study drug (and placebo) will be given intravenously, meaning that it will be given through a vein into the arm. During the study, the participant will also complete various tests and assessments at each of the study visits. These include a check of the participant’s health, physical examinations, and blood and urine tests.
Cardior Pharmaceuticals GmbH. is sponsoring this research and site will be paid for conducting this study.REC name
North West - Haydock Research Ethics Committee
REC reference
22/NW/0392
Date of REC Opinion
20 Apr 2023
REC opinion
Further Information Favourable Opinion