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
NCT ID: NCT06979375
Last Updated: 2025-12-31
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
2025-06-30
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 + SoC
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.
CDR132L
Administered intravenous infusion of CDR132L once every 4 weeks for 48 weeks.
Placebo + SoC
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
Administered intravenous infusion of placebo once every 4 weeks for 48 weeks.
Interventions
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CDR132L
Administered intravenous infusion of CDR132L once every 4 weeks for 48 weeks.
Placebo
Administered intravenous infusion of placebo once every 4 weeks for 48 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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 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 ventricular end-diastolic diameter indexed to body surface area (LVEDDi)≥3.0 cm/m\^2 for male participants and ≥3.1 centimeter per meter square (cm/m\^2) for female participants 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.
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 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.
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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Concord Repatriation General Hospital - Cardiology Department
Concord, New South Wales, Australia
The Prince Charles Hospital
Brisbane, Queensland, 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
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.
České Budějovice, , Czechia
Fakultní Nemocnice Ostrava
Ostrava-Poruba, , Czechia
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
IKEM
Prague, , Czechia
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
Vadodara, Gujarat, India
Lisie Hospital
Kochi, Kerala, India
Seth GS Medical College & KEM Hospital
Mumbai, Maharashtra, India
Arneja Heart & Multispeciality Hospital
Nagpur, Maharashtra, India
Arneja Heart & Multispeciality Hospital
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
Dayanand Medical College & Hospital
Ludhiana, Punjab, India
Shri Mahant Indiresh Hospital
Dehradun, Uttarakhand, India
Sir Ganga Ram Hospital-Cardiology
New Delhi, , 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
Osaka University Hospital_Cardiovascular medicine
Osaka, , 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
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, Lower Silesian Voivodeship, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, Podlaskie Voivodeship, Poland
Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej
Biała Podlaska, , 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
Severance Hospital, Yonsei University Health System
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 Universitario de Gerona Doctor Josep Trueta
Girona, Catalonia, Spain
Hospital Univ. Virgen de la Arrixaca
El Palmar, Murcia, Spain
Hospital del Mar
Barcelona, , Spain
Hospital de Dénia
Denia, , Spain
Hospital Virgen de la Arrixaca
El Palmar, , Spain
Hospital Univ. de Gran Canaria Doctor Negrín
Las Palmas de Gran Canaria, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Clinico Virgen de la Victoria
Málaga, , Spain
Hospital Virgen del Rocío
Seville, , 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 - Cardiology
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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U1111-1313-4591
Identifier Type: OTHER
Identifier Source: secondary_id
2024-515797-27
Identifier Type: OTHER
Identifier Source: secondary_id
jRCT2031250305
Identifier Type: REGISTRY
Identifier Source: secondary_id
NN6706-8282
Identifier Type: -
Identifier Source: org_study_id