RecruitingPhase 2NCT06979375

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

Phase 2, Multicentre, Randomised, Double-blind, Placebo-controlled Safety and Efficacy Study of CDR132L on Reverse Cardiac Remodelling in Participants With Heart Failure With Reduced/Mildly Reduced Ejection Fraction and Left Ventricular Hypertrophy

Sponsor

Novo Nordisk A/S

Enrollment

200 participants

Start Date

Jun 30, 2025

Study Type

INTERVENTIONAL

Conditions

Heart Failure

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.

Eligibility

Min Age: 40 YearsMax Age: 84 Years

Plain Language Summary

Simplified for easier understanding

This study is testing CDR132L — an RNA-based drug — in people with heart failure with reduced ejection fraction (HFrEF), where the heart pumps out less than 50% of its blood with each beat. Researchers want to see whether this drug can improve the heart's structure and function over time. **You may be eligible if...** - You are between 40 and 84 years old - You have had symptomatic heart failure for at least 6 months - Your heart's ejection fraction is below 50% - You have evidence of an enlarged or thickened heart muscle on echocardiogram - You are on stable, optimized heart failure medications - Your NT-proBNP blood marker is 300 or above **You may NOT be eligible if...** - You have severe kidney disease (eGFR below 30) - You have recently had a heart attack or acute kidney injury - You have had a recent hospitalization for severe heart failure - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCDR132L

Administered intravenous infusion of CDR132L once every 4 weeks for 48 weeks.

DRUGPlacebo

Administered intravenous infusion of placebo once every 4 weeks for 48 weeks.

Locations(92)

Concord Repatriation General Hospital - Cardiology Department

Concord, New South Wales, Australia

The Prince Charles Hospital

Brisbane, Queensland, Australia

Royal Adelaide Hospital - Cardiology Department

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

Pratia Prague, s.r.o

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

JA Shizuoka Kohseiren Enshu Hospital_ Cardiology

Hamamatsu-shi, Shizuoka, 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

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

The University of Osaka 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

AmsterdamUMC AMC

Amsterdam, Netherlands

Zuyderland ziekenhuis - Cardiologie

Heerlen, Netherlands

Radboudumc

Nijmegen, Netherlands

Erasmus MC

Rotterdam, Netherlands

VieCuri - Cardiologie

Venlo, Netherlands

4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu

Wroclaw, Lower Silesian Voivodeship, Poland

1 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ

Lublin, Lublin 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 Univ. 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_Cardiología

Denia, Spain

Hospital Virgen de la Arrixaca

El Palmar, Spain

Hospital Univ. de Gran Canaria Doctor Negrín

Las Palmas de Gran Canaria, Spain

Hospital Ramón y Cajal_Cardiología

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Spain

H. Clinico Univ. Virgen de la Victoria

Málaga, Spain

Hospital Universitario 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

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NCT06979375

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