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
- Registration Number
- NCT06979362
- 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 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 ≥30 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 30 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 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: Dose 1 CDR132L Participants will receive intravenous infusion of CDR132L dose 1 once every 4 weeks for 48 weeks. Participants will also continue their individually adapted guideline-directed Standard of care (SoC) therapy for heart failure. CDR132L: Dose 2 CDR132L Participants will receive intravenous infusion of CDR132L dose 2 once every 4 weeks for 48 weeks. Participants will also continue their individually adapted guideline-directed Standard of care (SoC) therapy for heart failure. CDR132L: Dose 3 CDR132L Participants will receive intravenous infusion of CDR132L dose 3 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 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 Measured as ratio to baseline.
- Secondary Outcome Measures
Name Time Method Main phase: Change in composite Z-score based on the 3 outcome measures LVMi (CMR), LAVi (CMR) and 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 mass indexed to body surface area \[LVMi (Cardiovascular Magnetic Resonance \[CMR\])\], left atrial volume indexed to body surface area \[LAVi (CMR)\] and N-terminal pro B-type natriuretic peptide (NT-proBNP).
Main phase: Change in miR-132 From baseline to week 24 Measured as ratio to baseline.
Main phase: Number of adverse events From baseline to week 24 Measured as count of events.
Extension phase: Number of adverse events From baseline to week 60 Measured as count of events.
Trial Locations
- Locations (83)
Sengupta Hospital and Research Institute
🇮🇳Nagpur, Maharashtra, India
Duke University_Durham
🇺🇸Durham, North Carolina, United States
Univ of Alabama Birmingham
🇺🇸Birmingham, Alabama, United States
Pima Heart and Vascular
🇺🇸Tucson, Arizona, United States
Valley Clinical Trials
🇺🇸Northridge, California, United States
UCSD NAFLD Research Center
🇺🇸La Jolla, 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
CPC Clinical Research & Community Health
🇺🇸Aurora, Colorado, United States
Inpatient Research Clinic LLC
🇺🇸Miami Lakes, Florida, United States
AdventHealth Orlando
🇺🇸Orlando, Florida, United States
UofL Health Care Outpatient
🇺🇸Louisville, Kentucky, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
University of Minnesota_Minneapolis_1
🇺🇸Minneapolis, Minnesota, United States
Icahn Sch of Med-Mt Sinai Hosp
🇺🇸New York, New York, United States
Providence St. Vincent Heart
🇺🇸Portland, Oregon, United States
Amarillo Heart Clinical Research Institute
🇺🇸Amarillo, Texas, 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
University of Texas Southwestern Medical Center
🇺🇸Dallas, 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
St Pauls Hospital
🇨🇦Vancouver, British Columbia, Canada
Hamilton Hlth Sc. - General Site
🇨🇦Hamilton, Ontario, Canada
Hamilton General Hospital
🇨🇦Hamilton, Ontario, Canada
Toronto Heart Centre THC St. Michael's Heart Centre
🇨🇦Toronto, Ontario, Canada
Women's College Hospital
🇨🇦Toronto, Ontario, Canada
Winchester Dist Memorial Hosp
🇨🇦Winchester, Ontario, Canada
Sana Klinikum Berlin-Brandenburg-Lichtenberg - Innere Medizin II
🇩🇪Berlin, Germany
Herzzentrum Dresden GmbH Universitätsklinik
🇩🇪Dresden, Germany
Cardio Health Clinical Trials
🇨🇦Mississauga, Ontario, Canada
University of Ottawa Heart Ins
🇨🇦Ottawa, Ontario, Canada
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 - A unit of Synergy Lifecare Pvt
🇮🇳Vadodara, Gujarat, India
All India Institute of Medical Sciences (AIIMS), Nagpur
🇮🇳Nagpur, Maharashtra, India
VMMC & Safdarjung Hospital
🇮🇳New Dehli, New Delhi, India
Apollo Hospital Chennai
🇮🇳Chennai, Tamil Nadu, India
Osmania General Hospital
🇮🇳Hyderabad, Telangana, India
IPGME&R and SSKM Hospital
🇮🇳Kolkata, West Bengal, India
Sir Ganga Ram Hospital-Cardiology
🇮🇳New Delhi, India
NIPPON MEDICAL SCHOOL HOSPITAL_Cardiovascular medicine
🇯🇵Bunkyo-ku, Tokyo, Japan
Medical Research Institute KITANO HOSPITAL_Cardiovascular Medicine
🇯🇵Osaka-shi, Osaka, Japan
Osaka Metropolitan University Hospital_Cardiovascular Medicine
🇯🇵Osaka-Shi, 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
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
Kagawa University Hospital_Cardiology
🇯🇵Kita-gun, Kagawa, Japan
Kobe City Medical Center General Hospital_Cardiology
🇯🇵Kobe-shi, Hyogo, Japan
Chungbuk National University Hospital
🇰🇷Cheongju, Korea, Republic of
Wonju Severance Christian Hospital
🇰🇷Gangwon-do, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Keimyung University Dongsan Hospital
🇰🇷Daegu, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
🇵🇱Wroclaw, Dolnoslaskie, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
🇵🇱Białystok, Podlaskie, Poland
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
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 Virgen de la Arrixaca
🇪🇸El Palmar, Murcia, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Kings College Hospital
🇬🇧London, United Kingdom
Hospital Universitario La Paz
🇪🇸Madrid, Spain
The Royal Brompton Hospital - Cardiovascular Research Centre/Respiratory CRF
🇬🇧London, United Kingdom
The James Cook University Hospital
🇬🇧Middlesbrough, United Kingdom
Hospital Clínico Universitario de Valencia
🇪🇸Valencia, Spain
Wycombe General Hospital
🇬🇧High Wycombe, United Kingdom