A Research Study Comparing CDR132L With Placebo on the Structure and Function of the Heart in People With Heart Failure With Reduced/Mildly Reduced Ejection Fraction and Left Ventricular Hypertrophy
- Registration Number
- NCT06979375
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Age 40-84 years (both inclusive) at the time of signing the informed consent.
- Documented symptomatic heart failure (HF) diagnosed greater than or equal to (≥) 180 days prior to screening with at least weekly need for oral diuretic treatment, and New York Heart Association class II-III at screening.
- Clinically stable and on optimized doses and unchanged drug classes of guideline-directed HF therapy ≥ 45 days prior to randomisation.
- Left ventricular ejection fraction (LVEF) less than (<) 50 percent (%) as assessed by echocardiography at screening, measured by central laboratory.
- Left ventricular mass indexed to body surface area (LVMi) greater than (>) 88 gram per meter square (g/m^2) for female participants and >102 g/m^2 for male participants as assessed by echocardiography at screening, using the truncated ellipsoid method measured by central laboratory.
- Left ventricular end-diastolic diameter indexed to body surface area (LVEDDi)≥3.0 cm/m^2 for male participants and ≥3.1 centimeter per meter square (cm/m^2) for female participants as assessed by echocardiography at screening, measured by central laboratory.
- Body mass index 18.5-40 kilogram per meter square (kg/m^2) (both inclusive) and body weight less than or equal to (≤) 140 kilogram (kg). Body mass index is calculated in the electronic case report form based on height and body weight at the screening visit (visit 1).
- N-terminal pro B-type natriuretic peptide (NT-proBNP) ≥ 300 picograms per milliliter (pg/mL); NT-proBNP ≥600 pg/mL if atrial fibrillation/flutter is present at time of screening, measured by central laboratory.
- Estimated Glomerular Filtration Rate (eGFR) less than (<) 30 milliliter/minute/ 1.73-meter square (mL/min/1.73 m^2) at time of screening, measured by central laboratory.
- Participants with an episode of acute kidney failure or acute kidney injury, at the discretion of the investigator,within 90 days prior to randomisation.
- Myocardial infarction, unstable angina pectoris or HF hospitalization within 30 days prior to screening.
- Participants receiving intravenous HF medications within 45 days prior to randomisation.
- Planned coronary revascularization, pacemaker/cardioverter-defibrillator/cardiac resynchronization therapy (CRT) implantation, ablation of cardiac arrythmias or valve repair/replacement at the time of randomisation.
- Stroke or transient ischemic attack within 12 months prior to randomisation.
- Participants with potential disruption of the blood-brain barrier (e.g., multiple sclerosis), in the opinion of the investigator.
- Known history of severe liver disease and/or alanine aminotransferase or aspartate aminotransferase greater than (>) 2.5x upper limit of normal at screening, measured by central laboratory.
- Known genetic (or highly suspected due to family history) cause of increased cardiac mass (including dilated cardiomyopathy, Fabry disease and likely pathogenic or pathogenic variants within hypertrophic cardiomyopathy (HCM).
- Participants with suspected or diagnosed cardiac amyloidosis or sarcoidosis.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CDR132L + SoC CDR132L Participants will receive intravenous infusion of CDR132L once every 4 weeks for 48 weeks. Participants will also continue their individually adapted guideline-directed Standard of care (SoC) therapy for heart failure. Placebo + SoC Placebo Participants will receive intravenous infusion of placebo once every 4 weeks for 48 weeks. Participants will also continue their individually adapted guideline-directed Standard of care (SoC) therapy for heart failure.
- Primary Outcome Measures
Name Time Method Main Phase: Change in normalised microRNA-132-3p (miR-132) From baseline to week 24 Ratio to baseline
- Secondary Outcome Measures
Name Time Method Main Phase: Change in composite Z-score based on the 3 outcome measures: LVEDVi; LVESVi; NT-proBNP From baseline to week 24 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)
Main Phase: Number of adverse events From baseline to week 24 Count
Extension Phase: Number of adverse events From baseline to week 60 Count
Trial Locations
- Locations (81)
Concord Repatriation General Hospital - Cardiology Department
🇦🇺Concord, New South Wales, Australia
Sana Kliniken Berlin-Brandenburg GmbH - Lichtenberg
🇩🇪Berlin, Germany
Charité - Campus Benjamin Franklin - Klinik für Kardiologie
🇩🇪Berlin, Germany
Charité - Campus Virchow-Klinikum - Kardiologie, Angiologie und Intensivmedizin (CRU)
🇩🇪Berlin, Germany
Uniklinik TU Dresden - Herzzentrum Dresden GmbH
🇩🇪Dresden, Germany
Medizinische Hochschule Hannover - Kardiologie und Angiologie
🇩🇪Hanover, Germany
UniklinikHeidelberg - Innere Med. III - Kardiologie, Angiologie, Pneumologie
🇩🇪Heidelberg, Germany
Uniklinik Schleswig-Holstein - Med. Klinik III Kardiologie und Internist. Intensivmedizin
🇩🇪Kiel, Germany
The University of Osaka Hospital_Cardiovascular medicine
🇯🇵Osaka, Japan
Krakowski Szpital Specjalistyczny im. Jana Pawla II
🇵🇱Krakow, Poland
Scroll for more (71 remaining)Concord Repatriation General Hospital - Cardiology Department🇦🇺Concord, New South Wales, Australia