Actively Recruiting
Phase 2 Randomized, Double-blind, Placebo-controlled Study of CDR132L on Heart Structure and Function in Heart Failure Patients with Preserved Ejection Fraction and Left Ventricular Hypertrophy
Led by Novo Nordisk A/S · Updated on 2026-03-11
200
Participants Needed
109
Research Sites
36 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how CDR132L, a potential new medicine, affects the structure and function of the heart in people living with heart failure who have preserved ejection fraction and left ventricular hypertrophy. The study is a Phase 2, randomized, placebo-controlled trial lasting about 60 weeks, aiming to understand the impact of different doses of CDR132L on heart remodeling and related biomarkers. Participants will be randomly assigned to receive one of three different doses of CDR132L or a placebo. Each treatment is given as an intravenous infusion once every four weeks for 48 weeks. Alongside the study treatment, participants will continue their individually adjusted standard care therapy for heart failure. The trial includes a main phase and an extension phase to monitor effects over time. During the study, participants will undergo various assessments including measurement of microRNA-132-3p levels from baseline to week 24, heart imaging scans to evaluate changes in heart muscle and atrial volume, and monitoring of NT-proBNP levels, a marker of heart failure. Safety is closely tracked by recording adverse events during both the main and extension phases. The entire participation period spans approximately 60 weeks, with ongoing evaluation of the heart's structure and function.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 40 to 84 years at the time of signing informed consent
- Documented symptomatic chronic heart failure diagnosed at least 90 days before screening with at least weekly need for oral diuretics
- New York Heart Association class II-III at screening
- Clinically stable and on optimized doses of guideline-directed heart failure therapy for at least 45 days before randomization
- Left ventricular ejection fraction 50% or higher by echocardiography at screening
- Left ventricular hypertrophy confirmed by echocardiography with specified measurements depending on sex
- Body mass index between 18.5 and 40 kg/m2 and body weight up to 140 kg
- NT-proBNP 300 pg/mL or higher; if atrial fibrillation/flutter is present, NT-proBNP 600 pg/mL or higher
You will not qualify if you...
- Estimated glomerular filtration rate less than 30 mL/min/1.73 m2 at screening
- Episode of acute kidney failure or injury within 90 days before randomization
- Myocardial infarction, unstable angina, or heart failure hospitalization within 30 days before screening
- Receiving intravenous heart failure medications within 45 days before randomization
- Presence of CRT, pacemaker, or implantable cardioverter-defibrillator
- Planned coronary revascularization, device implantation, ablation, or valve repair at randomization
- Stroke or transient ischemic attack within 12 months before randomization
- Potential blood-brain barrier disruption conditions like multiple sclerosis
- Severe liver disease or elevated liver enzymes over 2.5 times the upper limit of normal
- Known or suspected genetic causes of increased cardiac mass such as dilated cardiomyopathy or Fabry disease
- Suspected or diagnosed cardiac amyloidosis or sarcoidosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 48 weeks
Participants receive intravenous infusions of CDR132L or placebo once every 4 weeks while continuing their usual heart failure therapy.
Approximately 12 infusion visits (in-person)
Trial Site Locations
Total: 109 locations
1
Univ of Alabama Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
TMC Hlthcr Clin Res Office
Tucson, Arizona, United States, 85712
Not Yet Recruiting
3
Pima Heart and Vascular
Tucson, Arizona, United States, 85741
Not Yet Recruiting
4
Valley Clinical Trials
Covina, California, United States, 91723
Actively Recruiting
5
UCSD NAFLD Research Center
La Jolla, California, United States, 92037
Not Yet Recruiting
6
Valley Clinical Trials
Northridge, California, United States, 91325
Actively Recruiting
7
University of California, San Francisco
San Francisco, California, United States, 94110
Not Yet Recruiting
8
University of California San Francisco UCSF
San Francisco, California, United States, 94143
Actively Recruiting
9
Harbor-UCLA Medical Center
Torrance, California, United States, 90502
Not Yet Recruiting
10
CPC Clinical Research & Community Health
Aurora, Colorado, United States, 80045
Not Yet Recruiting
11
Inpatient Research Clinic LLC
Miami Lakes, Florida, United States, 33014
Actively Recruiting
12
AdventHealth Orlando
Orlando, Florida, United States, 32803
Not Yet Recruiting
13
Guardian Research Org LLC
Winter Park, Florida, United States, 32792
Not Yet Recruiting
14
UofL Health Care Outpatient
Louisville, Kentucky, United States, 40202
Not Yet Recruiting
15
Henry Ford Hospital_Detroit
Detroit, Michigan, United States, 48202
Actively Recruiting
16
University of Minnesota_Minneapolis_1
Minneapolis, Minnesota, United States, 55455
Completed
17
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Not Yet Recruiting
18
Icahn Sch of Med-Mt Sinai Hosp
New York, New York, United States, 10029
Not Yet Recruiting
19
Duke University
Durham, North Carolina, United States, 27710
Not Yet Recruiting
20
Providence St. Vincent Heart
Portland, Oregon, United States, 97225
Completed
21
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Completed
22
Capital Area Research LLC
Camp Hill, Pennsylvania, United States, 17011
Actively Recruiting
23
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Not Yet Recruiting
24
Amarillo Medical Specialists
Amarillo, Texas, United States, 79124
Not Yet Recruiting
25
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390-9302
Actively Recruiting
26
Texama Medical Center
Denison, Texas, United States, 75020
Not Yet Recruiting
27
East Texas Cardiology PA
Houston, Texas, United States, 77002
Actively Recruiting
28
Inova Heart and Vascular Institute
Falls Church, Virginia, United States, 22042
Not Yet Recruiting
29
Sentara Bayside Hospital
Norfolk, Virginia, United States, 23507-1904
Completed
30
St Pauls Hospital
Vancouver, British Columbia, Canada, V6Z1Y6
Completed
31
William Osler Hel Bra Civic Hs
Brampton, Ontario, Canada, L6R 3J7
Not Yet Recruiting
32
Hamilton Hlth Sc. - General Site
Hamilton, Ontario, Canada, L8L 2X2
Not Yet Recruiting
33
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 5G4
Completed
34
Cardio Health Clinical Trials
Hamilton, Ontario, Canada, L8W 3K5
Not Yet Recruiting
35
Cardio Health Clinical Trials
Mississauga, Ontario, Canada, L5M 2S6
Actively Recruiting
36
University of Ottawa Heart Ins
Ottawa, Ontario, Canada, K1Y 4W7
Actively Recruiting
37
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Not Yet Recruiting
38
Women's College Hospital
Toronto, Ontario, Canada, M5S 1B1
Not Yet Recruiting
39
Winchester Dist Memorial Hosp
Winchester, Ontario, Canada, K0C 2K0
Actively Recruiting
40
Unv de Cardiologie et dePneum
Québec, Canada, G1V 4G5
Not Yet Recruiting
41
Sana Kliniken Berlin-Brandenburg GmbH - Lichtenberg
Berlin, Germany, 10365
Completed
42
Charité - Campus Benjamin Franklin - Klinik für Kardiologie
Berlin, Germany, 12203
Not Yet Recruiting
43
Charité - Campus Virchow-Klinikum - Kardiologie, Angiologie und Intensivmedizin (CRU)
Berlin, Germany, 13353
Actively Recruiting
44
Uniklinik TU Dresden - Herzzentrum Dresden GmbH
Dresden, Germany, 01307
Actively Recruiting
45
Universitaetsklinikum Essen - Klinik für Kardiologie und Angiologie
Essen, Germany, 45147
Not Yet Recruiting
46
Universitätsklinikum Frankfurt aM - Kardiologie
Frankfurt am Main, Germany, 60596
Actively Recruiting
47
Universitätsklinikum Halle - Innere Medizin III
Halle, Germany, 06120
Actively Recruiting
48
Medizinische Hochschule Hannover - Kardiologie und Angiologie
Hanover, Germany, 30625
Actively Recruiting
49
UniklinikHeidelberg - Innere Med. III - Kardiologie, Angiologie, Pneumologie
Heidelberg, Germany, 69120
Actively Recruiting
50
Uniklinik Schleswig-Holstein - Med. Klinik III Kardiologie und Internist. Intensivmedizin
Kiel, Germany, 24105
Actively Recruiting
51
Rhythm Heart Institute - A unit of Synergy Lifecare Pvt
Vadodara, Gujarat, India, 390022
Actively Recruiting
52
Sengupta Hospital and Research Institute
Nagpur, Maharashtra, India, 440033
Actively Recruiting
53
All India Institute of Medical Sciences (AIIMS), Nagpur
Nagpur, Maharashtra, India, 441108
Actively Recruiting
54
All India Institute of Medical Sciences (AIIMS), Nagpur
Nagpur, Maharashtra, India, 441108
Not Yet Recruiting
55
G B Pant Institute of Postgraduate Medical Education and Research
New Delhi, National Capital Territory of Delhi, India, 110022
Actively Recruiting
56
VMMC & Safdarjung Hospital
New Dehli, New Delhi, India, 110029
Actively Recruiting
57
VMMC & Safdarjung Hospital
New Dehli, New Delhi, India, 110029
Not Yet Recruiting
58
Apollo Hospital Chennai
Chennai, Tamil Nadu, India, 600006
Actively Recruiting
59
Apollo Hospital Chennai
Chennai, Tamil Nadu, India, 600006
Not Yet Recruiting
60
Osmania General Hospital
Hyderabad, Telangana, India, 500012
Actively Recruiting
61
Osmania General Hospital
Hyderabad, Telangana, India, 500012
Not Yet Recruiting
62
Shri Mahant Indiresh Hospital
Dehradun, Uttarakhand, India, 248001
Actively Recruiting
63
IPGME&R and SSKM Hospital
Kolkata, West Bengal, India, 700020
Actively Recruiting
64
Sir Ganga Ram Hospital-Cardiology
New Delhi, India, 110060
Actively Recruiting
65
NIPPON MEDICAL SCHOOL HOSPITAL_Cardiovascular medicine
Bunkyo-ku, Tokyo, Japan, 113-8603
Actively Recruiting
66
Hyogo Prefectural HarimaHimeji General Medical Center_Cardiology
Himeji-shi, Hyogo, Japan, 670-8560
Actively Recruiting
67
National Hospital Organization Mito Medical Center_Cardiovascular medicine
Ibaraki, Japan, 311-3193
Actively Recruiting
68
Yokohama City University Medical Center_Cardiovascular Center
Kanagawa, Japan, 232-0024
Actively Recruiting
69
Yokohama City University Medical Center_Cardiovascular Center
Kanagawa, Japan, 232-0024
Not Yet Recruiting
70
Kagawa University Hospital_Cardiology
Kita-gun, Kagawa, Japan, 761-0793
Completed
71
Kobe City Medical Center General Hospital_Cardiology
Kobe-shi, Hyogo, Japan, 650-0047
Actively Recruiting
72
Medical Research Institute KITANO HOSPITAL_Cardiovascular Medicine
Osaka-shi, Osaka, Japan, 530-8480
Actively Recruiting
73
Osaka Metropolitan University Hospital_Cardiovascular Medicine
Osaka-Shi, Osaka, Japan, 545-8586
Actively Recruiting
74
Sapporo Medical University Hospital_Cardiovascular, Kidney, Metabolism Endocrinology
Sapporo-shi, Hokkaido, Japan, 060-8543
Actively Recruiting
75
National Hospital Organization Yokohama Medical Center_Cardiology
Yokohama-shi, Kanagawa, Japan, 245-8575
Actively Recruiting
76
4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
Wroclaw, Lower Silesian Voivodeship, Poland, 50-981
Actively Recruiting
77
1 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ
Lublin, Lublin Voivodeship, Poland, 20-049
Not Yet Recruiting
78
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, Podlaskie Voivodeship, Poland, 15-276
Not Yet Recruiting
79
American Heart of Poland S.A.
Bielsko-Biala, Poland, 43-316
Not Yet Recruiting
80
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
Krakow, Poland, 30-688
Not Yet Recruiting
81
Krakowski Szpital Specjalistyczny im. Jana Pawla II
Krakow, Poland, 31-202
Actively Recruiting
82
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o.
Krakow, Poland, 31-826
Actively Recruiting
83
Instytut Centrum Zdrowia Matki Polki
Lodz, Poland, 93-338
Not Yet Recruiting
84
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Lublin, Poland, 20-090
Actively Recruiting
85
Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu
Przemyśl, Poland, 37-700
Actively Recruiting
86
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
Warsaw, Poland, 04-628
Actively Recruiting
87
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Wroclaw, Poland, 50-556
Actively Recruiting
88
Chungbuk National University Hospital
Cheongju-si, South Korea, 28644
Actively Recruiting
89
Keimyung University Dongsan Hospital
Daegu, South Korea, 42601
Actively Recruiting
90
Wonju Severance Christian Hospital
Gangwon-do, South Korea, 26426
Actively Recruiting
91
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 13620
Completed
92
Korea University Anam Hospital
Seoul, South Korea, 02841
Actively Recruiting
93
Korea University Guro Hospital
Seoul, South Korea, 08308
Completed
94
Korea University Guro Hospital
Seoul, South Korea, 08308
Withdrawn
95
Hospital Universitario San Cecilio
Granada, Andalusia, Spain, 18016
Actively Recruiting
96
Hospital Univ. Virgen de la Arrixaca
El Palmar, Murcia, Spain, 30120
Actively Recruiting
97
Hospital del Mar
Barcelona, Spain, 08003
Actively Recruiting
98
Hosp. U Gran Canaria Dr. Negrín_Cardiologia
Las Palmas de Gran Canaria, Spain, 35010
Not Yet Recruiting
99
Hospital Ramón y Cajal_Cardiología
Madrid, Spain, 28034
Not Yet Recruiting
100
Hospital Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
101
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Actively Recruiting
102
Trialmed - Midlands
Birmingham, United Kingdom, B15 2SQ
Actively Recruiting
103
Wycombe General Hospital
High Wycombe, United Kingdom, HP11 2TT
Not Yet Recruiting
104
St Bartholomew's Hospital - Cardiac Research Office
London, United Kingdom, EC1A 7BE
Not Yet Recruiting
105
St Bartholomew's Hospital - Cardiology
London, United Kingdom, EC1A 7BE
Not Yet Recruiting
106
Kings College Hospital
London, United Kingdom, SE5 9RS
Actively Recruiting
107
The Royal Brompton Hospital - Respiratory CRF
London, United Kingdom, SW3 6HP
Not Yet Recruiting
108
The James Cook University Hospital - Cardiology
Middlesbrough, United Kingdom, TS4 3BW
Actively Recruiting
109
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Not Yet Recruiting
Research Team
N
Novo Nordisk
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here