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
- Registration Number
- NCT06979375
- Lead Sponsor
- Novo Nordisk A/S
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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 ≥ 30 days prior to randomization.
- Left ventricular ejection fraction (LVEF) less than (<) 50 percent (%) as assessed by echocardiography at screening, measured by central laboratory.
- Left ventricular mass indexed to body surface area (LVMi) greater than (>) 88 gram per meter square (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.
- Left atrial volume indexed to body surface area (LAVi) ≥ 29 milliliter per meter square (mL/m^2) as assessed by echocardiography at screening, measured by central laboratory.
- 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.
- 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 randomization.
- Myocardial infarction, unstable angina pectoris or HF hospitalization within 30 days prior to screening.
- Participants receiving intravenous HF medications within 30 days prior to randomization.
- Planned coronary revascularization, pacemaker/cardioverter-defibrillator/cardiac resynchronization therapy (CRT) implantation, ablation of cardiac arrythmias or valve repair/replacement at the time of randomization.
- Stroke or transient ischemic attack within 12 months prior to randomization.
- 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 cause of increased cardiac mass (including likely pathogenic variants within dilated cardiomyopathy, hypertrophic cardiomyopathy and Fabry disease).
- Participants with suspected or diagnosed cardiac amyloidosis or sarcoidosis.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CDR132L + SoC CDR132L Participants will receive intravenous infusion of CDR132L once every 4 weeks for 48 weeks. Participants will also continue their individually adapted guideline-directed Standard of care (SoC) therapy for heart failure. Placebo + SoC Placebo Participants will receive intravenous infusion of placebo once every 4 weeks for 48 weeks. Participants will also continue their individually adapted guideline-directed Standard of care (SoC) therapy for heart failure.
- Primary Outcome Measures
Name Time Method Main Phase: Change in microRNA-132-3p (miR-132) From baseline to week 24 Ratio to baseline
- Secondary Outcome Measures
Name Time Method Main Phase: Change in composite Z-score based on the 3 outcome measures: LVEDVi; LVESVi; NT-proBNP From baseline to week 24 The composite Z-score is calculated as the mean of the participant's 3 Z-scores for the change in the 3 outcome measures: Left ventricular end-diastolic volume indexed to body surface area (LVEDVi); Left ventricular end-systolic volume indexed to body surface area (LVESVi); N-terminal pro B-type natriuretic peptide (NT-proBNP)
Main Phase: Number of adverse events From baseline to week 24 Count
Extension Phase: Number of adverse events From baseline to week 60 Count
Trial Locations
- Locations (75)
Victorian Heart Hospital
🇦🇺Clayton, Victoria, Australia
Fiona Stanley Hospital Cardiology
🇦🇺Murdoch, Western Australia, Australia
Fakultní nemocnice u sv. Anny v Brně
🇨🇿Brno, Czechia
Nemocnice České Budějovice a.s.
🇨🇿Ceske Budejovice, Czechia
Fakultní Nemocnice Ostrava
🇨🇿Ostrava-Poruba, Czechia
Concord Repatriation General Hospital - Cardiology
🇦🇺Concord, New South Wales, Australia
Royal Adelaide Hospital Cardiovascular Clinical Trials
🇦🇺Adelaide, South Australia, Australia
Flinders Medical Centre
🇦🇺Bedford Park, South Australia, Australia
Royal Hobart Hospital
🇦🇺Hobart, Tasmania, Australia
IKEM
🇨🇿Praha 4, Czechia
Vseobecna fakultni nemocnice v Praze
🇨🇿Praha, Czechia
Sana Klinikum Berlin-Brandenburg-Lichtenberg - Innere Medizin II
🇩🇪Berlin, Germany
Herzzentrum Dresden GmbH Universitätsklinik
🇩🇪Dresden, Germany
Universitaetsklinikum Essen - Klinik für Kardiologie und Angiologie
🇩🇪Essen, Germany
Universitätsklinikum Frankfurt aM - Kardiologie
🇩🇪Frankfurt am Main, Germany
Universitätsklinikum Halle - Innere Medizin III
🇩🇪Halle (Saale), Germany
Medizinische Hochschule Hannover, Klinik für Kardiologie und Angiologie
🇩🇪Hannover, Germany
Universitätsklinik Heidelberg Innere Medizin III Kardiologie, Angiologie, Pneumologie
🇩🇪Heidelberg, Germany
Universitätsklinikum Schleswig-Holstein - Medizinischen Klinik III Kardiologie und Internistische Intensivmedizin
🇩🇪Kiel, Germany
G B Pant Institute of Postgraduate Medical Education and Research
🇮🇳New Delhi, Delhi, India
Rhythm Heart Institute
🇮🇳Vadodara, Gujarat, India
Lisie Hospital
🇮🇳Kochi, Kerala, India
Seth GS Medical College & KEM Hospital
🇮🇳Mumbai, Maharashtra, India
Arneja Heart & Multispeciality Hospital
🇮🇳Nagpur, Maharashtra, India
VMMC & Safdarjung Hospital
🇮🇳New Dehli, New Delhi, India
Dayanand Medical College & Hospital
🇮🇳Ludhiana, Punjab, India
Shri Mahant Indiresh Hospital
🇮🇳Dehradun, Uttarakhand, India
Sir Ganga Ram Hospital-Cardiology
🇮🇳New Delhi, India
NIPPON MEDICAL SCHOOL HOSPITAL_Cardiovascular medicine
🇯🇵Bunkyo-ku, Tokyo, Japan
Yokohama City University Medical Center_Cardiovascular Center
🇯🇵Kanagawa, Japan
Kagawa University Hospital_Cardiology
🇯🇵Kita-gun, Kagawa, Japan
Kobe City Medical Center General Hospital_Cardiology
🇯🇵Kobe-shi, Hyogo, Japan
Hyogo Prefectural HarimaHimeji General Medical Center_Cardiology
🇯🇵Himeji-shi, Hyogo, Japan
National Hospital Organization Mito Medical Center_Cardiovascular medicine
🇯🇵Ibaraki, Japan
Medical Research Institute KITANO HOSPITAL_Cardiovascular Medicine
🇯🇵Osaka-shi, Osaka, Japan
Osaka Metropolitan University Hospital_Cardiovascular Medicine
🇯🇵Osaka-Shi, Osaka, Japan
Osaka University Hospital_Cardiovascular medicine
🇯🇵Osaka, Japan
Sapporo Medical University Hospital_Cardiovascular, Kidney, Metabolism Endocrinology
🇯🇵Sapporo-shi, Hokkaido, Japan
National Hospital Organization Yokohama Medical Center_Cardiology
🇯🇵Yokohama-shi, Kanagawa, Japan
Chungbuk National University Hospital
🇰🇷Cheongju, Korea, Republic of
Keimyung University Dongsan Hospital
🇰🇷Daegu, Korea, Republic of
Wonju Severance Christian Hospital
🇰🇷Gangwon-do, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Academisch Medisch Centrum
🇳🇱Amsterdam, Netherlands
Zuyderland ziekenhuis
🇳🇱Heerlen, Netherlands
Radboudumc
🇳🇱Nijmegen, Netherlands
Erasmus MC
🇳🇱Rotterdam, Netherlands
VieCuri
🇳🇱Venlo, Netherlands
4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
🇵🇱Wroclaw, Dolnoslaskie, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
🇵🇱Białystok, Podlaskie, Poland
Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej
🇵🇱Biala Podlaska, Poland
American Heart of Poland S.A.
🇵🇱Bielsko-Biała, Poland
Krakowski Szpital Specjalistyczny im. Jana Pawła II
🇵🇱Krakow, Poland
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o.
🇵🇱Kraków, Poland
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
🇵🇱Lublin, Poland
Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu
🇵🇱Przemysl, Poland
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
🇵🇱Warsaw, Poland
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
🇵🇱Wroclaw, Poland
Hospital Universitario San Cecilio
🇪🇸Granada, Andalucía, Spain
Hospital Universitario de Gerona Doctor Josep Trueta
🇪🇸Girona, Cataluña, Spain
Hospital Virgen de la Arrixaca
🇪🇸El Palmar, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital de Dénia
🇪🇸Dénia, Spain
Hospital Universitario de Gran Canaria Doctor Negrín
🇪🇸Las Palmas de Gran Canaria, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Clínico Virgen de la Victoria
🇪🇸Malaga, Spain
Hospital Virgen del Rocío
🇪🇸Sevilla, Spain
Hospital Clínico Universitario de Valencia
🇪🇸Valencia, Spain
Wycombe General Hospital
🇬🇧High Wycombe, United Kingdom
Kings College Hospital
🇬🇧London, United Kingdom
The Royal Brompton Hospital - Cardiovascular Research Centre/Respiratory CRF
🇬🇧London, United Kingdom
The James Cook University Hospital
🇬🇧Middlesbrough, United Kingdom