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
Administered intravenous infusion of CDR132L once every 4 weeks for 48 weeks.
Administered intravenous infusion of placebo once every 4 weeks for 48 weeks.
Concord Repatriation General Hospital - Cardiology Department
Concord, New South Wales, Australia
RECRUITINGThe Prince Charles Hospital
Brisbane, Queensland, Australia
NOT_YET_RECRUITINGRoyal Adelaide Hospital Cardiovascular Clinical Trials
Adelaide, South Australia, Australia
RECRUITINGFlinders Medical Centre
Bedford Park, South Australia, Australia
Main Phase: Change in normalised microRNA-132-3p (miR-132)
Ratio to baseline
Time frame: From baseline to week 24
Main Phase: Change in composite Z-score based on the 3 outcome measures: LVEDVi; LVESVi; 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 end-diastolic volume indexed to body surface area (LVEDVi); Left ventricular end-systolic volume indexed to body surface area (LVESVi); N-terminal pro B-type natriuretic peptide (NT-proBNP)
Time frame: From baseline to week 24
Main Phase: Number of adverse events
Count
Time frame: From baseline to week 24
Extension Phase: Number of adverse events
Count
Time frame: From baseline to week 60
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Royal Hobart Hospital
Hobart, Tasmania, Australia
RECRUITINGVictorian Heart Hospital
Clayton, Victoria, Australia
RECRUITINGFiona Stanley Hospital Cardiology
Murdoch, Western Australia, Australia
RECRUITINGFakultní nemocnice u sv. Anny v Brně
Brno, Czechia
COMPLETEDNemocnice České Budějovice a.s.
České Budějovice, Czechia
RECRUITINGFakultní Nemocnice Ostrava
Ostrava-Poruba, Czechia
RECRUITING...and 76 more locations