A Research Study Comparing CDR132L With Placebo on the Structure and Function of the Heart in People With Heart Failure With Reduced/Mildly Reduced Ejection Fraction and Left Ventricular Hypertrophy
Recruiting · NCT06979375 · 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 heart failure (HF) diagnosed greater than or equal to (≥) 180 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 optimized doses and unchanged drug classes of guideline-directed HF therapy ≥ 45 days prior to randomisation.
- Left ventricular ejection fraction (LVEF) less than (\<) 50 percent (%) as assessed by echocardiography at screening, measured by central laboratory.
- Left ventricular hypertrophy or left ventricular dilatation assessed by echocardiography at screening measured by central laboratory with any of the following:
- LVMi greater than (\>)88 g/m\^2 for female participants and \>102 g/m\^2 for male participants using the truncated ellipsoid method.
- LVMi \>95 g/m\^2 for female participants and \>115 g/m\^2 for male participants, using the linear method (cube formula).
- Left ventricular end-diastolic diameter indexed to body surface area (LVEDDi) \>3.1 cm/m\^2 for female participants and \>3.0 cm/m\^2 for male participants.
- Body mass index 18.5-40 kilogram per meter square (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).
- N-terminal pro B-type natriuretic peptide (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 (eGFR) less than (\<) 30 milliliter/minute/ 1.73-meter square (mL/min/1.73 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 hospitalization within 30 days prior to screening.
- Participants receiving intravenous HF medications within 45 days prior to randomisation.
- Planned coronary revascularization, pacemaker/cardioverter-defibrillator/cardiac resynchronization therapy (CRT) implantation, ablation of cardiac arrythmias or 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 greater than (\>) 2.5x 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.
- AmsterdamUMC AMC - Amsterdam, Netherlands
- 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
- Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej - Biała Podlaska, Poland
- American Heart of Poland S.A. - Bielsko-Biala, Poland
- Trialmed - Midlands - Birmingham, United Kingdom
- Fakultní nemocnice u sv. Anny v Brně - Brno, Czechia
- 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
- Hospital de Dénia_Cardiología - Denia, Spain
- Uniklinik TU Dresden - Herzzentrum Dresden GmbH - Dresden, Germany
- Hospital Virgen de la Arrixaca - El Palmar, Spain
- 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
- JA Shizuoka Kohseiren Enshu Hospital_ Cardiology - Hamamatsu-shi, Shizuoka, Japan
- Medizinische Hochschule Hannover - Kardiologie und Angiologie - Hanover, Germany
- Zuyderland ziekenhuis - Cardiologie - Heerlen, Netherlands
- 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
- 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
- Krakowski Szpital Specjalistyczny im. Jana Pawla II - Krakow, Poland
- Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o. - Krakow, Poland
- Hospital Univ. de Gran Canaria Doctor Negrín - Las Palmas de Gran Canaria, Spain
- St Bartholomew's Hospital - Cardiac Research Office - London, United Kingdom
- St Bartholomew's Hospital - Cardiology - London, United Kingdom
- Kings College Hospital - London, United Kingdom
- The Royal Brompton Hospital - Respiratory CRF - London, United Kingdom
- Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie - Lublin, Poland
- Hospital Ramón y Cajal_Cardiología - Madrid, Spain
- Hospital Universitario La Paz - Madrid, Spain
- Hospital Universitario Puerta de Hierro Majadahonda - Majadahonda, Spain
- The James Cook University Hospital - Cardiology - Middlesbrough, United Kingdom
- H. Clinico Univ. Virgen de la Victoria - Málaga, Spain
- Sir Ganga Ram Hospital-Cardiology - New Delhi, India
- Sir Ganga Ram Hospital-Cardiology - New Delhi, India
- Radboudumc - Nijmegen, Netherlands
- The University of Osaka Hospital_Cardiovascular medicine - Osaka, Japan
- Osaka Metropolitan University Hospital_Cardiovascular Medicine - Osaka-Shi, Osaka, Japan
- Medical Research Institute KITANO HOSPITAL_Cardiovascular Medicine - Osaka-shi, Osaka, Japan
- Fakultní Nemocnice Ostrava - Ostrava-Poruba, Czechia
- Vseobecna fakultni nemocnice v Praze - Prague, Czechia
- Pratia Prague, s.r.o - Prague, Czechia
- IKEM - Prague, Czechia
- Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu - Przemyśl, Poland
- Erasmus MC - Rotterdam, Netherlands
- Sapporo Medical University Hospital_Cardiovascular, Kidney, Metabolism Endocrinology - Sapporo-shi, Hokkaido, Japan
- Seoul National University Bundang Hospital - Seongnam-si, Gyeonggi-do, South Korea
- Korea University Anam Hospital - Seoul, South Korea
- Severance Hospital, Yonsei University Health System - Seoul, South Korea
Showing 60 of 92 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →