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 · NCT06979362 · Interventional (participants receive a specific treatment) · Lead sponsor: Novo Nordisk A/S
View the official record on ClinicalTrials.gov →Interventions studied
CDR132LPlacebo
What this trial is about
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.
Who can take part
Age range
40 Years to 84 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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:
- 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
- LVMi \>95 g/m2 for female participants and \>115 g/m2 for male participants using the linear method (cube formula).
- 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.
Where it is running
60 locations listed across 16 US states.
- Univ of Alabama Birmingham - Birmingham, Alabama, United States
- TMC Hlthcr Clin Res Office - Tucson, Arizona, United States
- Pima Heart and Vascular - Tucson, Arizona, United States
- Valley Clinical Trials - Covina, California, United States
- UCSD NAFLD Research Center - La Jolla, California, United States
- Valley Clinical Trials - Northridge, California, United States
- University of California, San Francisco - San Francisco, California, United States
- University of California San Francisco UCSF - San Francisco, California, United States
- Harbor-UCLA Medical Center - Torrance, California, United States
- Univ of Colorado at Denver - Aurora, Colorado, United States
- Inpatient Research Clinic LLC - Miami Lakes, Florida, United States
- AdventHealth Orlando - Orlando, Florida, United States
- Guardian Research Org LLC - Winter Park, Florida, United States
- UofL Health Care Outpatient - Louisville, Kentucky, United States
- Henry Ford Hospital_Detroit - Detroit, Michigan, United States
- University of Minnesota_Minneapolis_1 - Minneapolis, Minnesota, United States
- Washington University School of Medicine - St Louis, Missouri, United States
- Icahn Sch of Med-Mt Sinai Hosp - New York, New York, United States
- Duke University - Durham, North Carolina, United States
- Providence St. Vincent Heart - Portland, Oregon, United States
- Abington Memorial Hospital - Abington, Pennsylvania, United States
- Capital Area Research LLC - Camp Hill, Pennsylvania, United States
- Vanderbilt University Medical Center - Nashville, Tennessee, United States
- Amarillo Medical Specialists - Amarillo, Texas, United States
- University of Texas Southwestern Medical Center - Dallas, Texas, United States
- Texama Medical Center - Denison, Texas, United States
- East Texas Cardiology PA - Houston, Texas, United States
- Inova Heart and Vascular Institute - Falls Church, Virginia, United States
- Sentara Bayside Hospital - Norfolk, Virginia, United States
- Hospital del Mar - Barcelona, Spain
- Sana Kliniken Berlin-Brandenburg GmbH - Lichtenberg - Berlin, Germany
- Charité - Campus Benjamin Franklin - Klinik für Kardiologie - Berlin, Germany
- Charité - Campus Virchow-Klinikum - Kardiologie, Angiologie und Intensivmedizin (CRU) - Berlin, Germany
- American Heart of Poland S.A. - Bielsko-Biala, Poland
- Trialmed - Midlands - Birmingham, United Kingdom
- NIPPON MEDICAL SCHOOL HOSPITAL_Cardiovascular medicine - Bunkyo-ku, Tokyo, Japan
- Chungbuk National University Hospital - Cheongju-si, South Korea
- Keimyung University Dongsan Hospital - Daegu, South Korea
- Uniklinik TU Dresden - Herzzentrum Dresden GmbH - Dresden, Germany
- Universitaetsklinikum Essen - Klinik für Kardiologie und Angiologie - Essen, Germany
- Universitätsklinikum Frankfurt aM - Kardiologie - Frankfurt am Main, Germany
- Wonju Severance Christian Hospital - Gangwon-do, South Korea
- Universitätsklinikum Halle - Innere Medizin III - Halle, Germany
- Medizinische Hochschule Hannover - Kardiologie und Angiologie - Hanover, Germany
- UniklinikHeidelberg - Innere Med. III - Kardiologie, Angiologie, Pneumologie - Heidelberg, Germany
- Wycombe General Hospital - High Wycombe, United Kingdom
- Hyogo Prefectural HarimaHimeji General Medical Center_Cardiology - Himeji-shi, Hyogo, Japan
- National Hospital Organization Mito Medical Center_Cardiovascular medicine - Ibaraki, Japan
- Mitoyo General Hospital_Cardiovascular medicine - Kagawa, Japan
- Yokohama City University Medical Center_Cardiovascular Center - Kanagawa, Japan
- Yokohama City University Medical Center_Cardiovascular Center - Kanagawa, Japan
- Uniklinik Schleswig-Holstein - Med. Klinik III Kardiologie und Internist. Intensivmedizin - Kiel, Germany
- Kagawa University Hospital_Cardiology - Kita-gun, Kagawa, Japan
- Kobe City Medical Center General Hospital_Cardiology - Kobe-shi, Hyogo, Japan
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie - Krakow, Poland
- Krakowski Szpital Specjalistyczny im. Jana Pawla II - Krakow, Poland
- Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o. - Krakow, Poland
- Hosp. U Gran Canaria Dr. Negrín_Cardiologia - Las Palmas de Gran Canaria, Spain
- Instytut Centrum Zdrowia Matki Polki - Lodz, Poland
- St Bartholomew's Hospital - Cardiac Research Office - London, United Kingdom
Showing 60 of 117 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →