Testing CDR132L against a placebo 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
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
Interventions
CDR132L
CDR132L will be administered intravenously once every 4 weeks.
Placebo
Placebo will be administered intravenously once every 4 weeks.
Canadian Sites (12)
IUCPQ - Universite Laval
Québec, Canada
St Pauls Hospital
Vancouver, British Columbia, Canada
William Osler Hel Bra Civic Hs
Brampton, Ontario, Canada
Hamilton Hlth Sc. - General Site
Hamilton, Ontario, Canada
Hamilton General Hospital
Hamilton, Ontario, Canada
Premier Clinical Trial Research Network (PCTRN)
Hamilton, Ontario, Canada
Cardio Health Clinical Trials
Hamilton, Ontario, Canada
Cardio Health Clinical Trials
Mississauga, Ontario, Canada
University of Ottawa Heart Institute (UOHI)
Ottawa, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Women's College Hospital
Toronto, Ontario, Canada
Winchester Dist Memorial Hosp
Winchester, Ontario, Canada
Eligibility Criteria
See who this study is looking for21 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Age 40-84 years (both inclusive) at the time of signing the informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- +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 visitScreeningThe checks done before joining, to see whether a study fits.Read more → (visit 1)
- +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 randomisationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →
- +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.
- +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
- −Estimated glomerular filtration rate lesser than (\<) 30 milliliter per minute (mL/min)/1.73 square meter (m\^2) at time of screeningScreeningThe checks done before joining, to see whether a study fits.Read more →, measured by central laboratory
- −Participants with an episode of acute kidney failure or acute kidney injury, at the discretion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, within 90 days prior to randomisationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →
- −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.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
What is being given or done in this study: CDR132L, PlaceboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
There are 4 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists an age range of 40 years to 84 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 200 people.
The study is currently expected to finish around July 2028.
The main measurement is taken over: From baselineBaselineYour starting measurements, taken before treatment begins.Read more → to week 24.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Main phase: Change in normalised microRNA-132-3p (miR-132) — measured over From baselineBaselineYour starting measurements, taken before treatment begins.Read more → to week 24.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06979362 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About CDR132LDrug
CDR132L will be administered intravenously once every 4 weeks.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboDrug
Placebo will be administered intravenously once every 4 weeks.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 40 years to 84 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 40 years to 84 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: From baselineBaselineYour starting measurements, taken before treatment begins.Read more → to week 24.
The study as a whole is currently expected to finish around 2028-07-25.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 200 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 11 locations, including: Québec, Canada; Vancouver, British Columbia, Canada; Brampton, Ontario, Canada; Hamilton, Ontario, Canada; Mississauga, Ontario, Canada; Ottawa, Ontario, Canada, and 5 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (3)
Henry Ford Hospital_Detroit
Detroit, Michigan, United States
University of Minnesota_Minneapolis_1
Minneapolis, Minnesota, United States
Icahn Sch of Med-Mt Sinai Hosp
New York, New York, United States
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.