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
NCT ID: NCT06979362
Last Updated: 2025-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
200 participants
INTERVENTIONAL
2025-06-27
2028-01-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CDR132L: Dose 1
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
CDR132L will be administered intravenously once every 4 weeks.
CDR132L: Dose 2
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
CDR132L will be administered intravenously once every 4 weeks.
CDR132L: Dose 3
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.
CDR132L
CDR132L will be administered intravenously once every 4 weeks.
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.
Placebo
Placebo will be administered intravenously once every 4 weeks.
Interventions
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CDR132L
CDR132L will be administered intravenously once every 4 weeks.
Placebo
Placebo will be administered intravenously once every 4 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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.
40 Years
84 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency (dept. 2834)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Univ of Alabama Birmingham
Birmingham, Alabama, 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
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
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
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
St Pauls Hospital
Vancouver, British Columbia, Canada
Hamilton Hlth Sc. - General Site
Hamilton, Ontario, Canada
Hamilton General Hospital
Hamilton, Ontario, Canada
Cardio Health Clinical Trials
Mississauga, Ontario, Canada
University of Ottawa Heart Ins
Ottawa, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Women's College Hospital
Toronto, Ontario, Canada
Winchester Dist Memorial Hosp
Winchester, Ontario, Canada
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
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
Universitätsklinikum Halle - Innere Medizin III
Halle, , Germany
Medizinische Hochschule Hannover - Kardiologie und Angiologie
Hanover, , Germany
UniklinikHeidelberg - Innere Med. III - Kardiologie, Angiologie, Pneumologie
Heidelberg, , Germany
Uniklinik Schleswig-Holstein - Med. Klinik III Kardiologie und Internist. Intensivmedizin
Kiel, , Germany
Rhythm Heart Institute - A unit of Synergy Lifecare Pvt
Vadodara, Gujarat, India
Sengupta Hospital and Research Institute
Nagpur, Maharashtra, India
All India Institute of Medical Sciences (AIIMS), Nagpur
Nagpur, Maharashtra, India
All India Institute of Medical Sciences (AIIMS), Nagpur
Nagpur, Maharashtra, India
G B Pant Institute of Postgraduate Medical Education and Research
New Delhi, National Capital Territory of Delhi, India
VMMC & Safdarjung Hospital
New Dehli, New Delhi, India
Apollo Hospital Chennai
Chennai, Tamil Nadu, India
Apollo Hospital Chennai
Chennai, Tamil Nadu, India
Osmania General Hospital
Hyderabad, Telangana, India
Osmania General Hospital
Hyderabad, Telangana, India
Shri Mahant Indiresh Hospital
Dehradun, Uttarakhand, 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
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
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
4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
Wroclaw, Lower Silesian Voivodeship, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, Podlaskie Voivodeship, Poland
American Heart of Poland S.A.
Bielsko-Biala, , Poland
Krakowski Szpital Specjalistyczny im. Jana Pawla II
Krakow, , Poland
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o.
Krakow, , Poland
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Lublin, , Poland
Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu
Przemyśl, , Poland
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
Warsaw, , Poland
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Wroclaw, , Poland
Chungbuk National University Hospital
Cheongju-si, , South Korea
Keimyung University Dongsan Hospital
Daegu, , South Korea
Wonju Severance Christian Hospital
Gangwon-do, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Hospital Universitario San Cecilio
Granada, Andalusia, Spain
Hospital Univ. Virgen de la Arrixaca
El Palmar, Murcia, Spain
Hospital del Mar
Barcelona, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Trialmed - Midlands
Birmingham, , United Kingdom
Wycombe General Hospital
High Wycombe, , United Kingdom
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
The James Cook University Hospital
Middlesbrough, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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U1111-1313-3984
Identifier Type: OTHER
Identifier Source: secondary_id
2024-515796-35
Identifier Type: OTHER
Identifier Source: secondary_id
jRCT2031250304
Identifier Type: REGISTRY
Identifier Source: secondary_id
NN6706-8212
Identifier Type: -
Identifier Source: org_study_id
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