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Compares treatment options for Heart Failure
Official 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
ClinicalTrials.gov ID: NCT06979362
What this study is testing
What is CDR132L?
CDR132L is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for heart failure.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 60 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 84
You may be able to join if
- 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...
- 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
- Left ventricular hypertrophy assessed by echocardiography at screening measured by central laboratory with any of the following:
You likely can't join if
- Estimated glomerular filtration rate lesser than (\<) 30 milliliter per minute (mL/min)/1.73 square meter (m\^2) at time of screening, measured by...
- Participants with an episode of acute kidney failure or acute kidney injury, at the discretion of the investigator, within 90 days prior to...
- 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...
See the full eligibility 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 New York Heart Association class II-III at...
- 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
- Left ventricular hypertrophy assessed by echocardiography at screening measured by central laboratory with any of the following:
- 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
- LVMi \>95 g/m2 for female participants and \>115 g/m2 for male participants using the linear method (cube formula).
- 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 18.5-40 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...
- 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
- 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...
- Participants with suspected or diagnosed cardiac amyloidosis or sarcoidosis.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Tucson, Arizona, United States
- Covina, California, United States
- La Jolla, California, United States
- Northridge, California, United States
- San Francisco, California, United States
- Torrance, California, United States
- Aurora, Colorado, United States
- Miami Lakes, Florida, United States
- Orlando, Florida, United States
- Winter Park, Florida, United States
- Louisville, Kentucky, United States
- Detroit, Michigan, United States
- Minneapolis, Minnesota, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Portland, Oregon, United States
- Abington, Pennsylvania, United States
- Camp Hill, Pennsylvania, United States
+ 72 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 60 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 84 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Tucson, Arizona, United States; Covina, California, United States; La Jolla, California, United States; Northridge, California, United States; San Francisco, California, United States and 86 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.