Summary

Eligibility
for people ages 40-84 (full criteria)
Location
at Torrance, California and other locations
Dates
study started
completion around

Description

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.

Official Title

Phase 2, Multicentre, Randomised, Double-blind, Placebo-controlled Safety and Efficacy Study of CDR132L on Reverse Cardiac Remodelling in Participants With Heart Failure With Preserved Ejection Fraction and Left Ventricular Hypertrophy

Keywords

Heart Failure, Left Ventricular Hypertrophy, Hypertrophy, CDR132L

Eligibility

You can join if…

Open to people ages 40-84

  • 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 ≥30 days prior to randomisation
  • Left ventricular ejection fraction ≥50% as assessed by echocardiography at screening, measured by central laboratory
  • LVMi (greater than) >88 gram per square meter (g/m2) for female participants and >102 g/m2 for male participants as assessed by echocardiography at screening, using the truncated ellipsoid method measured by central laboratory
  • LAVi ≥29 milliliter per square meter (mL/m2) as assessed by echocardiography at screening, measured by central laboratory
  • Body mass index 18.5-40 kilogram per square meter (kg/m2) (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)
  • 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

You CAN'T join if...

  • Estimated glomerular filtration rate lesser than (<) 30 milliliter per minute (mL/min)/1.73 square meter (m2) 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 30 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
  • Known history of severe liver disease and/or alanine aminotransferase or aspartate aminotransferase >2.5 x upper limit of normal at screening, measured by central laboratory
  • Known genetic cause of increased cardiac mass (including likely pathogenic variants within dilated cardiomyopathy, hypertrophic cardiomyopathy and Fabry disease)
  • Participants with suspected or diagnosed cardiac amyloidosis or sarcoidosis.

Locations

  • Harbor-UCLA Medical Center
    Torrance California 90502 United States
  • Valley Clinical Trials
    Covina California 91723 United States
  • Valley Clinical Trials
    Northridge California 91723 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Novo Nordisk A/S
ID
NCT06979362
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 200 study participants
Last Updated