RecruitingHeart Failure

A Research Study Comparing Different Doses of CDR132L With Placebo on the Structure and Function of the Heart in People With Heart Failure With Preserved Ejection Fraction and Left Ventricular Hypertrophy

Eligible age

40–84 yrs

Accepts

All genders

Locations

16 states

Healthy volunteers

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About this study

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.

Sponsor: Novo Nordisk A/S

You may qualify if…

✓ Age 40-84 years (both inclusive) at the time of signing the informed consent
✓ Documented symptomatic chronic heart failure (HF) diagnosed greater than or equal to (≥) 90 days prior to screening with at least weekly need for oral diuretic treatment, and/or a sodium-glucose cotransporter-2 inhibitor (SGLT2i), and New York Heart Association class II-III at screening
✓ Clinically stable and on optimised doses and unchanged drug classes of guideline-directed HF therapy ≥45 days prior to randomisation
✓ Left ventricular ejection fraction ≥40% as assessed by echocardiography at screening, measured by central laboratory
✓ Left ventricular hypertrophy assessed by echocardiography at screening measured by central laboratory with any of the following:
✓ 1. LVMi (greater than) \>88 gram per square meter (g/m\^2) for female participants and \>102 g/m\^2 for male participants, using the truncated ellipsoid method measured by central laboratory
✓ 2. LVMi \>95 g/m2 for female participants and \>115 g/m2 for male participants using the linear method (cube formula).
✓ 3. Interventricular septum diameter measured in diastole (IVSd) in the parasternal long axis view ≥1.1 cm for female participants and ≥1.2 cm for male participants.

You may not qualify if…

✕ Estimated glomerular filtration rate lesser than (\<) 30 milliliter per minute (mL/min)/1.73 square meter (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 hospitalisation within 30 days prior to screening
✕ Participants receiving intravenous HF medications within 45 days prior to randomisation
✕ Participants with CRT, pacemaker or implantable cardioverter-defibrillator
✕ Planned coronary revascularisation, pacemaker/cardioverter-defibrillator/CRT implantation, ablation of cardiac arrythmias and 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