RECRUITING

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

Description

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.

Conditions

Study Overview

Study Details

Study overview

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.

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

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

Condition
Heart Failure
Intervention / Treatment

-

Contacts and Locations

Birmingham

Univ of Alabama Birmingham, Birmingham, Alabama, United States, 35233

Tucson

Pima Heart and Vascular, Tucson, Arizona, United States, 85741

Covina

Valley Clinical Trials, Covina, California, United States, 91723

La Jolla

UCSD NAFLD Research Center, La Jolla, California, United States, 92037

Northridge

Valley Clinical Trials, Northridge, California, United States, 91325

San Francisco

University of California, San Francisco, San Francisco, California, United States, 94110

San Francisco

University of California San Francisco UCSF, San Francisco, California, United States, 94143

Torrance

Harbor-UCLA Medical Center, Torrance, California, United States, 90502

Aurora

CPC Clinical Research & Community Health, Aurora, Colorado, United States, 80045

Miami Lakes

Inpatient Research Clinic LLC, Miami Lakes, Florida, United States, 33014

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * LVMi (greater than) \>88 gram per square meter (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
  • * LAVi ≥29 milliliter per square meter (mL/m\^2) as assessed by echocardiography at screening, measured by central laboratory
  • * Body mass index 18.5-40 kilogram per square meter (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)
  • * 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 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
  • * 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 (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.

Ages Eligible for Study

40 Years to 84 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Novo Nordisk A/S,

Clinical Transparency (dept. 2834), STUDY_DIRECTOR, Novo Nordisk A/S

Study Record Dates

2028-01-23