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

Status: Recruiting
Location: See all (79) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 84
Healthy Volunteers: f
View:

• 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 ≥ 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.

Locations
Other Locations
Australia
Royal Adelaide Hospital Cardiovascular Clinical Trials
RECRUITING
Adelaide
Flinders Medical Centre
RECRUITING
Bedford Park
Victorian Heart Hospital
RECRUITING
Clayton
Concord Repatriation General Hospital - Cardiology Department
RECRUITING
Concord
Royal Hobart Hospital
RECRUITING
Hobart
Fiona Stanley Hospital Cardiology
NOT_YET_RECRUITING
Murdoch
Germany
Charité - Campus Benjamin Franklin - Klinik für Kardiologie
NOT_YET_RECRUITING
Berlin
Charité - Campus Virchow-Klinikum - Kardiologie, Angiologie und Intensivmedizin (CRU)
NOT_YET_RECRUITING
Berlin
Sana Kliniken Berlin-Brandenburg GmbH - Lichtenberg
WITHDRAWN
Berlin
Uniklinik TU Dresden - Herzzentrum Dresden GmbH
NOT_YET_RECRUITING
Dresden
Universitaetsklinikum Essen - Klinik für Kardiologie und Angiologie
NOT_YET_RECRUITING
Essen
Universitätsklinikum Frankfurt aM - Kardiologie
NOT_YET_RECRUITING
Frankfurt Am Main
Universitätsklinikum Halle - Innere Medizin III
RECRUITING
Halle
Medizinische Hochschule Hannover - Kardiologie und Angiologie
NOT_YET_RECRUITING
Hanover
UniklinikHeidelberg - Innere Med. III - Kardiologie, Angiologie, Pneumologie
RECRUITING
Heidelberg
Uniklinik Schleswig-Holstein - Med. Klinik III Kardiologie und Internist. Intensivmedizin
RECRUITING
Kiel
India
Shri Mahant Indiresh Hospital
RECRUITING
Dehradun
Lisie Hospital
RECRUITING
Kochi
Dayanand Medical College & Hospital
RECRUITING
Ludhiana
Seth GS Medical College & KEM Hospital
NOT_YET_RECRUITING
Mumbai
Arneja Heart & Multispeciality Hospital
NOT_YET_RECRUITING
Nagpur
Arneja Heart & Multispeciality Hospital
RECRUITING
Nagpur
VMMC & Safdarjung Hospital
NOT_YET_RECRUITING
New Dehli
G B Pant Institute of Postgraduate Medical Education and Research
RECRUITING
New Delhi
Sir Ganga Ram Hospital-Cardiology
RECRUITING
New Delhi
Sir Ganga Ram Hospital-Cardiology
NOT_YET_RECRUITING
New Delhi
Rhythm Heart Institute
RECRUITING
Vadodara
Japan
NIPPON MEDICAL SCHOOL HOSPITAL_Cardiovascular medicine
NOT_YET_RECRUITING
Bunkyo-ku, Tokyo
Hyogo Prefectural HarimaHimeji General Medical Center_Cardiology
RECRUITING
Himeji-shi, Hyogo
National Hospital Organization Mito Medical Center_Cardiovascular medicine
RECRUITING
Ibaraki
Yokohama City University Medical Center_Cardiovascular Center
NOT_YET_RECRUITING
Kanagawa
Kagawa University Hospital_Cardiology
WITHDRAWN
Kita-gun, Kagawa
Kobe City Medical Center General Hospital_Cardiology
NOT_YET_RECRUITING
Kobe-shi, Hyogo
The University of Osaka Hospital_Cardiovascular medicine
RECRUITING
Osaka
Medical Research Institute KITANO HOSPITAL_Cardiovascular Medicine
RECRUITING
Osaka-shi, Osaka
Osaka Metropolitan University Hospital_Cardiovascular Medicine
RECRUITING
Osaka-shi, Osaka
Sapporo Medical University Hospital_Cardiovascular, Kidney, Metabolism Endocrinology
RECRUITING
Sapporo-shi, Hokkaido
National Hospital Organization Yokohama Medical Center_Cardiology
RECRUITING
Yokohama-shi, Kanagawa
Netherlands
Academisch Medisch Centrum
RECRUITING
Amsterdam
Zuyderland ziekenhuis
NOT_YET_RECRUITING
Heerlen
Radboudumc
NOT_YET_RECRUITING
Nijmegen
Erasmus MC
RECRUITING
Rotterdam
VieCuri
NOT_YET_RECRUITING
Venlo
Poland
Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej
NOT_YET_RECRUITING
Biała Podlaska
Uniwersytecki Szpital Kliniczny w Bialymstoku
NOT_YET_RECRUITING
Bialystok
American Heart of Poland S.A.
NOT_YET_RECRUITING
Bielsko-biala
Krakowski Szpital Specjalistyczny im. Jana Pawla II
RECRUITING
Krakow
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o.
RECRUITING
Krakow
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
RECRUITING
Lublin
Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu
RECRUITING
Przemyśl
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
NOT_YET_RECRUITING
Warsaw
4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
RECRUITING
Wroclaw
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
RECRUITING
Wroclaw
Republic of Korea
Chungbuk National University Hospital
RECRUITING
Cheongju-si
Keimyung University Dongsan Hospital
RECRUITING
Daegu
Wonju Severance Christian Hospital
RECRUITING
Gangwon-do
Seoul National University Bundang Hospital
WITHDRAWN
Seongnam-si, Gyeonggi-do
Korea University Anam Hospital
RECRUITING
Seoul
Korea University Guro Hospital
RECRUITING
Seoul
Korea University Guro Hospital
NOT_YET_RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
Spain
Hospital del Mar
RECRUITING
Barcelona
Hospital de Dénia
RECRUITING
Denia
Hospital Univ. Virgen de la Arrixaca
RECRUITING
El Palmar
Hospital Virgen de la Arrixaca
NOT_YET_RECRUITING
El Palmar
Hospital Universitario de Gerona Doctor Josep Trueta
RECRUITING
Girona
Hospital Universitario San Cecilio
RECRUITING
Granada
Hospital Univ. de Gran Canaria Doctor Negrín
NOT_YET_RECRUITING
Las Palmas De Gran Canaria
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Clinico Virgen de la Victoria
RECRUITING
Málaga
Hospital Virgen del Rocío
NOT_YET_RECRUITING
Seville
Hospital Clinico Universitario de Valencia
RECRUITING
Valencia
United Kingdom
Trialmed - Midlands
NOT_YET_RECRUITING
Birmingham
Wycombe General Hospital
RECRUITING
High Wycombe
Kings College Hospital
RECRUITING
London
St Bartholomew's Hospital - Cardiac Research Office
NOT_YET_RECRUITING
London
The Royal Brompton Hospital - Cardiovascular Research Centre/Respiratory CRF
NOT_YET_RECRUITING
London
The James Cook University Hospital
RECRUITING
Middlesbrough
Southampton General Hospital
NOT_YET_RECRUITING
Southampton
Contact Information
Primary
Novo Nordisk
clinicaltrials@novonordisk.com
(+1) 866-867-7178
Time Frame
Start Date: 2025-06-30
Estimated Completion Date: 2028-01-23
Participants
Target number of participants: 200
Treatments
Experimental: 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.
Placebo_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Novo Nordisk A/S

This content was sourced from clinicaltrials.gov

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