This study will look into how CDR132L (a potential new medicine) works on the structure and function of the heart in people living with heart failure. Participants will either get CDR132L or placebo (a medicine which has no effect on the body), which treatment the participants get is decided by chance. The study will last for about 60 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
200
CDR132L will be administered intravenously once every 4 weeks.
Placebo will be administered intravenously once every 4 weeks.
Univ of Alabama Birmingham
Birmingham, Alabama, United States
RECRUITINGTMC Hlthcr Clin Res Office
Tucson, Arizona, United States
NOT_YET_RECRUITINGPima Heart and Vascular
Tucson, Arizona, United States
NOT_YET_RECRUITINGValley Clinical Trials
Covina, California, United States
Main phase: Change in normalised microRNA-132-3p (miR-132)
Measured as ratio to baseline.
Time frame: From baseline to week 24
Main phase: Change in composite Z-score based on the 3 outcome measures LVMi (CMR), LAVi (CMR) and NT-proBNP
The composite Z-score is calculated as the mean of the participant's 3 Z-scores for the change in the 3 outcome measures: left ventricular mass indexed to body surface area \[LVMi (Cardiovascular Magnetic Resonance \[CMR\])\], left atrial volume indexed to body surface area \[LAVi (CMR)\] and N-terminal pro B-type natriuretic peptide (NT-proBNP).
Time frame: From baseline to week 24
Main phase: Change in normalised miR-132
Measured as ratio to baseline.
Time frame: From baseline to week 24
Main phase: Number of adverse events
Measured as count of events.
Time frame: From baseline to week 24
Extension phase: Number of adverse events
Measured as count of events.
Time frame: From baseline to week 60
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UCSD NAFLD Research Center
La Jolla, California, United States
NOT_YET_RECRUITINGValley Clinical Trials
Northridge, California, United States
RECRUITINGUniversity of California, San Francisco
San Francisco, California, United States
NOT_YET_RECRUITINGUniversity of California San Francisco UCSF
San Francisco, California, United States
RECRUITINGHarbor-UCLA Medical Center
Torrance, California, United States
NOT_YET_RECRUITINGCPC Clinical Research & Community Health
Aurora, Colorado, United States
NOT_YET_RECRUITING...and 99 more locations