- 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 — Recruiting • Phase II • Cardiology / Cardiovascular • NCT06979362.
- What is being tested: CDR132L, a novel therapeutic agent, is being evaluated at different doses versus placebo to assess its effects on cardiac structure and function in heart failure with preserved ejection fraction (HFpEF) combined with left ventricular hypertrophy.
- Patient eligibility overview: The study recruits patients with HFpEF—a condition characterised by normal ejection fraction but impaired diastolic function—who also have evidence of left ventricular hypertrophy, representing a significant proportion of the heart failure population.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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.
- : * 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 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 ≥50% 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. * Body mass index 18.5-40 kilogram per square meter (kg/m^2) (both inclusive) and body weight less than or equal to (≤)…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.