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

Status: Recruiting
Location: See all (91) 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 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

Locations
United States
Alabama
Univ of Alabama Birmingham
NOT_YET_RECRUITING
Birmingham
Arizona
Pima Heart and Vascular
NOT_YET_RECRUITING
Tucson
California
Valley Clinical Trials
NOT_YET_RECRUITING
Covina
UCSD NAFLD Research Center
NOT_YET_RECRUITING
La Jolla
Valley Clinical Trials
NOT_YET_RECRUITING
Northridge
University of California San Francisco UCSF
NOT_YET_RECRUITING
San Francisco
University of California, San Francisco
NOT_YET_RECRUITING
San Francisco
Harbor-UCLA Medical Center
NOT_YET_RECRUITING
Torrance
Colorado
CPC Clinical Research & Community Health
NOT_YET_RECRUITING
Aurora
Florida
Inpatient Research Clinic LLC
RECRUITING
Miami Lakes
AdventHealth Orlando
NOT_YET_RECRUITING
Orlando
Kentucky
UofL Health Care Outpatient
NOT_YET_RECRUITING
Louisville
Michigan
Henry Ford Hospital
NOT_YET_RECRUITING
Detroit
Minnesota
University of Minnesota_Minneapolis_1
WITHDRAWN
Minneapolis
Missouri
Washington University School of Medicine
NOT_YET_RECRUITING
St Louis
North Carolina
Duke University_Durham
NOT_YET_RECRUITING
Durham
New York
Icahn Sch of Med-Mt Sinai Hosp
NOT_YET_RECRUITING
New York
Oregon
Providence St. Vincent Heart
WITHDRAWN
Portland
Pennsylvania
Abington Memorial Hospital
WITHDRAWN
Abington
Capital Area Research LLC
NOT_YET_RECRUITING
Camp Hill
Tennessee
Vanderbilt University Medical Center
NOT_YET_RECRUITING
Nashville
Texas
Amarillo Medical Specialists
NOT_YET_RECRUITING
Amarillo
University of Texas Southwestern Medical Center
NOT_YET_RECRUITING
Dallas
Texama Medical Center
NOT_YET_RECRUITING
Denison
East Texas Cardiology PA
NOT_YET_RECRUITING
Houston
Virginia
Inova Heart and Vascular Institute
NOT_YET_RECRUITING
Falls Church
Sentara Bayside Hospital
WITHDRAWN
Norfolk
Other Locations
Canada
Hamilton General Hospital
WITHDRAWN
Hamilton
Hamilton Hlth Sc. - General Site
NOT_YET_RECRUITING
Hamilton
Cardio Health Clinical Trials
NOT_YET_RECRUITING
Mississauga
University of Ottawa Heart Ins
NOT_YET_RECRUITING
Ottawa
St. Michael's Hospital
NOT_YET_RECRUITING
Toronto
Women's College Hospital
NOT_YET_RECRUITING
Toronto
St Pauls Hospital
WITHDRAWN
Vancouver
Winchester Dist Memorial Hosp
NOT_YET_RECRUITING
Winchester
Germany
Charité - Campus Benjamin Franklin - Klinik für Kardiologie
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
NOT_YET_RECRUITING
Halle
Medizinische Hochschule Hannover - Kardiologie und Angiologie
NOT_YET_RECRUITING
Hanover
UniklinikHeidelberg - Innere Med. III - Kardiologie, Angiologie, Pneumologie
NOT_YET_RECRUITING
Heidelberg
Universitätsklinikum Schleswig-Holstein - Med. Klinik III Kardiologie und Internist. Intensivmedizin
NOT_YET_RECRUITING
Kiel
India
Apollo Hospital Chennai
RECRUITING
Chennai
Apollo Hospital Chennai
NOT_YET_RECRUITING
Chennai
Osmania General Hospital
NOT_YET_RECRUITING
Hyderabad
Osmania General Hospital
RECRUITING
Hyderabad
IPGME&R and SSKM Hospital
NOT_YET_RECRUITING
Kolkata
All India Institute of Medical Sciences (AIIMS), Nagpur
NOT_YET_RECRUITING
Nagpur
Sengupta Hospital and Research Institute
RECRUITING
Nagpur
VMMC & Safdarjung Hospital
NOT_YET_RECRUITING
New Dehli
G B Pant Institute of Postgraduate Medical Education and Research
NOT_YET_RECRUITING
New Delhi
Sir Ganga Ram Hospital-Cardiology
NOT_YET_RECRUITING
New Delhi
Rhythm Heart Institute - A unit of Synergy Lifecare Pvt
RECRUITING
Vadodara
Japan
NIPPON MEDICAL SCHOOL HOSPITAL_Cardiovascular medicine
NOT_YET_RECRUITING
Bunkyo-ku, Tokyo
Hyogo Prefectural HarimaHimeji General Medical Center_Cardiology
NOT_YET_RECRUITING
Himeji-shi, Hyogo
National Hospital Organization Mito Medical Center_Cardiovascular medicine
NOT_YET_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
Medical Research Institute KITANO HOSPITAL_Cardiovascular Medicine
NOT_YET_RECRUITING
Osaka-shi, Osaka
Osaka Metropolitan University Hospital_Cardiovascular Medicine
NOT_YET_RECRUITING
Osaka-shi, Osaka
Sapporo Medical University Hospital_Cardiovascular, Kidney, Metabolism Endocrinology
NOT_YET_RECRUITING
Sapporo-shi, Hokkaido
National Hospital Organization Yokohama Medical Center_Cardiology
NOT_YET_RECRUITING
Yokohama-shi, Kanagawa
Poland
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 Pawła II
NOT_YET_RECRUITING
Krakow
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o.
NOT_YET_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
NOT_YET_RECRUITING
Daegu
Wonju Severance Christian Hospital
NOT_YET_RECRUITING
Gangwon-do
Seoul National University Bundang Hospital
WITHDRAWN
Seongnam-si, Gyeonggi-do
Korea University Anam Hospital
RECRUITING
Seoul
Korea University Guro Hospital
NOT_YET_RECRUITING
Seoul
Spain
Hospital del Mar
NOT_YET_RECRUITING
Barcelona
Hospital Univ. Virgen de la Arrixaca
NOT_YET_RECRUITING
El Palmar
Hospital Universitario San Cecilio
RECRUITING
Granada
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Clinico Universitario de Valencia
NOT_YET_RECRUITING
Valencia
United Kingdom
Trialmed - Midlands
NOT_YET_RECRUITING
Birmingham
Wycombe General Hospital
NOT_YET_RECRUITING
High Wycombe
Kings College Hospital
NOT_YET_RECRUITING
London
The Royal Brompton Hospital - Cardiovascular Research Centre/Respiratory CRF
NOT_YET_RECRUITING
London
The James Cook University Hospital
NOT_YET_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: 2025-06-27
Estimated Completion Date: 2028-01-23
Participants
Target number of participants: 200
Treatments
Experimental: 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.
Experimental: 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.
Experimental: 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.
Placebo_comparator: 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.
Sponsors
Leads: Novo Nordisk A/S

This content was sourced from clinicaltrials.gov

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