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
CDR132L: CDR132L will be administered intravenously once every 4 weeks.
Placebo: Placebo will be administered intravenously once every 4 weeks.
Study 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.
Eligibility
Sex
ALL
Min age
40 Years
Max age
84 Years
Healthy volunteers
No
Inclusion 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
* 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 (≤) 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
Exclusion Criteria:
* 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.
Primary outcome measure(s)
Main phase: Change in normalised microRNA-132-3p (miR-132) — From baseline to week 24 Measured as ratio to baseline.
Trial sites (117)
Facility
City
Region
Status
Univ of Alabama Birmingham
Birmingham
Alabama
Recruiting
TMC Hlthcr Clin Res Office
Tucson
Arizona
Not Yet Recruiting
Pima Heart and Vascular
Tucson
Arizona
Not Yet Recruiting
Valley Clinical Trials
Covina
California
Recruiting
UCSD NAFLD Research Center
La Jolla
California
Recruiting
Valley Clinical Trials
Northridge
California
Recruiting
University of California, San Francisco
San Francisco
California
Recruiting
University of California San Francisco UCSF
San Francisco
California
Recruiting
Harbor-UCLA Medical Center
Torrance
California
Recruiting
Univ of Colorado at Denver
Aurora
Colorado
Not Yet Recruiting
Inpatient Research Clinic LLC
Miami Lakes
Florida
Recruiting
AdventHealth Orlando
Orlando
Florida
Not Yet Recruiting
Guardian Research Org LLC
Winter Park
Florida
Not Yet Recruiting
UofL Health Care Outpatient
Louisville
Kentucky
Not Yet Recruiting
Henry Ford Hospital_Detroit
Detroit
Michigan
Recruiting
University of Minnesota_Minneapolis_1
Minneapolis
Minnesota
Completed
Washington University School of Medicine
St Louis
Missouri
Recruiting
Icahn Sch of Med-Mt Sinai Hosp
New York
New York
Not Yet Recruiting
Duke University
Durham
North Carolina
Recruiting
Providence St. Vincent Heart
Portland
Oregon
Completed
Abington Memorial Hospital
Abington
Pennsylvania
Completed
Capital Area Research LLC
Camp Hill
Pennsylvania
Recruiting
Vanderbilt University Medical Center
Nashville
Tennessee
Recruiting
Amarillo Medical Specialists
Amarillo
Texas
Not Yet Recruiting
University of Texas Southwestern Medical Center
Dallas
Texas
Recruiting
Texama Medical Center
Denison
Texas
Not Yet Recruiting
East Texas Cardiology PA
Houston
Texas
Recruiting
Inova Heart and Vascular Institute
Falls Church
Virginia
Recruiting
Sentara Bayside Hospital
Norfolk
Virginia
Completed
St Pauls Hospital
Vancouver
British Columbia
Completed
William Osler Hel Bra Civic Hs
Brampton
Ontario
Not Yet Recruiting
Hamilton Hlth Sc. - General Site
Hamilton
Ontario
Not Yet Recruiting
Hamilton General Hospital
Hamilton
Ontario
Completed
Premier Clinical Trial Research Network (PCTRN)
Hamilton
Ontario
Not Yet Recruiting
Cardio Health Clinical Trials
Hamilton
Ontario
Not Yet Recruiting
Cardio Health Clinical Trials
Mississauga
Ontario
Recruiting
University of Ottawa Heart Institute (UOHI)
Ottawa
Ontario
Recruiting
St. Michael's Hospital
Toronto
Ontario
Not Yet Recruiting
Women's College Hospital
Toronto
Ontario
Not Yet Recruiting
Winchester Dist Memorial Hosp
Winchester
Ontario
Recruiting
+ 77 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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