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
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 40 Years to 84 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 60 weeks
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "The study will last for about 60 weeks."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests different doses of CDR132L, a possible new medicine, against a placebo with no active medicine. It looks at heart structure and how well the heart works in people with heart failure and a thickened main pumping chamber. Treatment is chosen by chance, and the study lasts about 60 weeks.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are 40–84 years old when you agree to join.
- You have had heart failure for at least 90 days, with symptoms that limit daily activity. You need water pills at least weekly and/or take an SGLT2 inhibitor, a type of medicine used for heart failure.
- Your heart failure is stable. Your treatment doses have been adjusted for your needs, and your medicine types have not changed for at least 45 days before treatment is assigned.
- A heart ultrasound shows that your main pumping chamber pushes out at least 40% of its blood with each beat.
- A heart ultrasound shows a thickened main pumping chamber that meets the study’s measurement rules.
- Your body mass index (BMI), a measure based on height and weight, is 18.5–45. You weigh no more than 140 kilograms.
- Your NT-proBNP, a blood marker of heart strain, is at least 300 pg/mL, or at least 600 pg/mL if you have an irregular heartbeat called atrial fibrillation or flutter.
Who can't join
- You have very low kidney function (eGFR below 30), or had sudden kidney failure or injury within 90 days before treatment is assigned.
- You had a heart attack, unstable chest pain, or a hospital stay for heart failure within 30 days before screening, or received heart failure medicine through a vein within 45 days before treatment is assigned.
- You have a pacemaker, an implanted shock device, or a device that helps your heart’s chambers beat together.
- When treatment is assigned, you have plans for a procedure to improve heart blood flow, place a heart device, treat an abnormal heartbeat, or repair or replace a heart valve.
- You had a stroke or mini-stroke within 12 months before treatment is assigned, or the study doctor thinks you have a condition that may damage the brain’s protective blood barrier, such as multiple sclerosis.
- You have a history of severe liver disease, or liver blood tests called ALT or AST are more than 2.5 times the upper normal limit.
- You have a known or strongly suspected inherited cause of an enlarged or thickened heart.
- You have suspected or diagnosed cardiac amyloidosis or sarcoidosis, conditions that cause protein buildup or inflammation in the heart.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * 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/or a sodium-glucose cotransporter-2 inhibitor (SGLT2i), 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 ≥40% as assessed by echocardiography at screening, measured by central laboratory * Left ventricular hypertrophy assessed by echocardiography at screening measured by central laboratory with any of the following: 1. LVMi (greater than) \>88 gram per square meter (g/m\^2) for female participants and \>102 g/m\^2 for male participants, using the truncated ellipsoid method measured by central laboratory 2. LVMi \>95 g/m2 for female participants and \>115 g/m2 for male participants using the linear method (cube formula). 3. Interventricular septum diameter measured in diastole (IVSd) in the parasternal long axis view ≥1.1 cm for female participants and ≥1.2 cm for male participants. * Body mass index 18.5-45 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 Exclusion Criteria: * Estimated glomerular filtration rate lesser than (\<) 30 milliliter per minute (mL/min)/1.73 square meter (m\^2) at time of screening, measured by central laboratory * 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 hospitalisation within 30 days prior to screening * Participants receiving intravenous HF medications within 45 days prior to randomisation * Participants with CRT, pacemaker or implantable cardioverter-defibrillator * Planned coronary revascularisation, pacemaker/cardioverter-defibrillator/CRT implantation, ablation of cardiac arrythmias and 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 \>2.5 x 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.
Study sites (29)
AL
- Univ of Alabama Birmingham · Birmingham, AL 35233More trials in Birmingham
AZ
- TMC Hlthcr Clin Res Office · Tucson, AZ 85712More trials in Tucson
- Pima Heart and Vascular · Tucson, AZ 85741More trials in Tucson
CA
- Valley Clinical Trials · Covina, CA 91723More trials in Covina
- UCSD NAFLD Research Center · La Jolla, CA 92037More trials in La Jolla
- Valley Clinical Trials · Northridge, CA 91325More trials in Northridge
- University of California, San Francisco · San Francisco, CA 94110More trials in San Francisco
- University of California San Francisco UCSF · San Francisco, CA 94143More trials in San Francisco
- Harbor-UCLA Medical Center · Torrance, CA 90502More trials in Torrance
CO
- Univ of Colorado at Denver · Aurora, CO 80045More trials in Aurora
FL
- Inpatient Research Clinic LLC · Miami Lakes, FL 33014More trials in Miami Lakes
- AdventHealth Orlando · Orlando, FL 32803More trials in Orlando
- Guardian Research Org LLC · Winter Park, FL 32792More trials in Winter Park
KY
- UofL Health Care Outpatient · Louisville, KY 40202More trials in Louisville
MI
- Henry Ford Hospital_Detroit · Detroit, MI 48202More trials in Detroit
MN
- University of Minnesota_Minneapolis_1 · Minneapolis, MN 55455More trials in Minneapolis
MO
- Washington University School of Medicine · St Louis, MO 63110More trials in St Louis
NC
- Duke University · Durham, NC 27710More trials in Durham
NY
- Icahn Sch of Med-Mt Sinai Hosp · New York, NY 10029More trials in New York
OR
- Providence St. Vincent Heart · Portland, OR 97225More trials in Portland
PA
- Abington Memorial Hospital · Abington, PA 19001More trials in Abington
- Capital Area Research LLC · Camp Hill, PA 17011More trials in Camp Hill
TN
- Vanderbilt University Medical Center · Nashville, TN 37232More trials in Nashville
TX
- Amarillo Medical Specialists · Amarillo, TX 79124More trials in Amarillo
- University of Texas Southwestern Medical Center · Dallas, TX 75390-8830More trials in Dallas
- Texama Medical Center · Denison, TX 75020More trials in Denison
- East Texas Cardiology PA · Houston, TX 77002More trials in Houston
VA
- Inova Heart and Vascular Institute · Falls Church, VA 22042More trials in Falls Church
- Sentara Bayside Hospital · Norfolk, VA 23507-1904More trials in Norfolk