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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2025-06-27

Study Completion:2028-01-23

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06979362

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.

Ages Eligible for Study:40 Years to 84 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Novo Nordisk

CONTACT

(+1) 866-867-7178

clinicaltrials@novonordisk.com

Principal Investigator

Clinical Transparency (dept. 2834)

STUDY_DIRECTOR

Novo Nordisk A/S

Study Locations (Sites)

Univ of Alabama Birmingham

Birmingham, Alabama, 35233

United States

Pima Heart and Vascular

Tucson, Arizona, 85741

United States

Valley Clinical Trials

Covina, California, 91723

United States

UCSD NAFLD Research Center

La Jolla, California, 92037

United States

Valley Clinical Trials

Northridge, California, 91325

United States

University of California, San Francisco

San Francisco, California, 94110

United States

University of California San Francisco UCSF

San Francisco, California, 94143

United States

Harbor-UCLA Medical Center

Torrance, California, 90502

United States

CPC Clinical Research & Community Health

Aurora, Colorado, 80045

United States

Inpatient Research Clinic LLC

Miami Lakes, Florida, 33014

United States

AdventHealth Orlando

Orlando, Florida, 32803

United States

UofL Health Care Outpatient

Louisville, Kentucky, 40202

United States

Henry Ford Hospital

Detroit, Michigan, 48202-2689

United States

University of Minnesota_Minneapolis_1

Minneapolis, Minnesota, 55455

United States

Washington University School of Medicine

Saint Louis, Missouri, 63110

United States

Icahn Sch of Med-Mt Sinai Hosp

New York, New York, 10029

United States

Duke University_Durham

Durham, North Carolina, 27705

United States

Providence St. Vincent Heart

Portland, Oregon, 97225

United States

Abington Memorial Hospital

Abington, Pennsylvania, 19001

United States

Capital Area Research LLC

Camp Hill, Pennsylvania, 17011

United States

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

United States

Amarillo Medical Specialists

Amarillo, Texas, 79124

United States

University of Texas Southwestern Medical Center

Dallas, Texas, 75390-9302

United States

Texama Medical Center

Denison, Texas, 75020

United States

East Texas Cardiology PA

Houston, Texas, 77002

United States

Inova Heart and Vascular Institute

Falls Church, Virginia, 22042

United States

Sentara Bayside Hospital

Norfolk, Virginia, 23507-1904

United States

Collaborators and Investigators

Sponsor: Novo Nordisk A/S

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-27

Study Completion Date2028-01-23

Study Record Updates

Study Start Date2025-06-27

Study Completion Date2028-01-23

Terms related to this study

Additional Relevant MeSH Terms

Heart Failure