CDR132L versus placebo to improve heart structure and function in people with heart failure and left ventricular hypertrophy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2, randomized, placebo-controlled interventional trial testing CDR132L over about 60 weeks in people with symptomatic chronic heart failure, LVEF <50%, and echocardiographic left ventricular hypertrophy. Participants who meet entry criteria and are stable on guideline-directed heart failure therapy are randomly assigned to receive CDR132L or a matching placebo. Cardiac structure and function will be measured centrally by echocardiography and other standardized assessments during scheduled study visits. The trial is being run at several tertiary hospitals in Australia and is sponsored by Novo Nordisk.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 40-84 years (both inclusive) at the time of signing the informed consent.
* Documented symptomatic heart failure (HF) diagnosed greater than or equal to (≥) 180 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 optimized doses and unchanged drug classes of guideline-directed HF therapy ≥ 45 days prior to randomisation.
* Left ventricular ejection fraction (LVEF) less than (\<) 50 percent (%) as assessed by echocardiography at screening, measured by central laboratory.
* Left ventricular hypertrophy or left ventricular dilatation assessed by echocardiography at screening measured by central laboratory with any of the following:

  1. LVMi greater than (\>)88 g/m\^2 for female participants and \>102 g/m\^2 for male participants using the truncated ellipsoid method.
  2. LVMi \>95 g/m\^2 for female participants and \>115 g/m\^2 for male participants, using the linear method (cube formula).
  3. Left ventricular end-diastolic diameter indexed to body surface area (LVEDDi) \>3.1 cm/m\^2 for female participants and \>3.0 cm/m\^2 for male participants.
* Body mass index 18.5-40 kilogram per meter square (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).
* N-terminal pro B-type natriuretic peptide (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 (eGFR) less than (\<) 30 milliliter/minute/ 1.73-meter square (mL/min/1.73 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 hospitalization within 30 days prior to screening.
* Participants receiving intravenous HF medications within 45 days prior to randomisation.
* Planned coronary revascularization, pacemaker/cardioverter-defibrillator/cardiac resynchronization therapy (CRT) implantation, ablation of cardiac arrythmias or 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 greater than (\>) 2.5x 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.

Where it's running

• Concord Repatriation General Hospital - Cardiology Department
  Concord, New South Wales, Australia Recruiting
• Royal Adelaide Hospital - Cardiology Department
  Adelaide, South Australia, Australia Recruiting
• Flinders Medical Centre
  Bedford Park, South Australia, Australia Recruiting
• Royal Hobart Hospital
  Hobart, Tasmania, Australia Recruiting
• Victorian Heart Hospital
  Clayton, Victoria, Australia Recruiting
• Fiona Stanley Hospital - Cardiology
  Murdoch, Western Australia, Australia Recruiting

+42 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Novo Nordisk
• Email: clinicaltrials@novonordisk.com
• Phone: (+1) 866-867-7178

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using Apple Watch data to predict heart failure outcomes

  This study is testing if data from Apple Watches can help predict heart failure problems and the chances of needing to go back to the hospital for patients with heart failure.

  Recruiting University Medical Center Goettingen · Goettigen, Lower Saxony · NCT06819618

• Comparing Aortix Device to Diuretics for Acute Heart Failure

  This study is testing whether the Aortix device can help people with acute heart failure who aren't responding to diuretics feel better compared to standard treatment.

  Recruiting at 33 sites Procyrion · Phoenix, Arizona and 49 other locations · NCT05677100

• Myocardial Energetics Across Cardiovascular Disease Spectrum Using 31P-MRS

  Researchers are testing whether phosphorus-31 magnetic resonance spectroscopy (31P-MRS) can map heart energy metabolism across healthy people and patients with various heart conditions.

  Recruiting Chinese Academy of Medical Sciences, Fuwai Hospital · Beijing · NCT07912086

• Tailored digital support to cut sedentary time in long-term cardiac rehab

  In adults in a long-term cardiac rehabilitation program, this study tests whether a personalized behavioural program with digital tools can reduce daily sitting time.

  Recruiting University of Lisbon · Lisbon, Lisbon District · NCT07910812

• NT-proBNP–guided heart failure screening for people 65+ in rural China

  This study tests whether using NT-proBNP blood tests to guide heart failure screening in adults 65 and older in rural China can find unrecognized heart problems more effectively than symptom-based screening.

  Recruiting Jiangsu Taizhou People's Hospital · Nanjing · NCT07885488

• Voice-based detection of heart failure deterioration using Noah Labs Vox

  This study tests whether a voice-analysis app can flag worsening heart failure in adults by comparing its alerts to standard weight-based monitoring.

  Recruiting Noah Labs · Boston, Massachusetts · NCT07870395

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.