CDR132L for Heart Failure
(8212-Preserved Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how a new medicine, CDR132L, can help people with heart failure by examining its effects on the heart's structure and function. Participants will receive either CDR132L in one of three doses or a placebo, alongside their regular heart failure treatment, over about 60 weeks. It is ideal for those who have been managing chronic heart failure for at least 90 days and require frequent oral diuretics (medicines that help remove excess fluid). As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications for the trial?
The trial requires participants to be on stable doses of their current heart failure medications for at least 45 days before joining. It doesn't specify stopping other medications, so you may not need to stop them, but it's best to discuss with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that CDR132L, a new treatment being tested for heart failure, has promising safety results from earlier studies. These studies found that CDR132L can improve heart function and structure without causing major safety issues. The treatment works by blocking a small molecule called microRNA-132, which is linked to heart failure.
In earlier research, patients did not experience serious side effects, suggesting that CDR132L is generally well-tolerated. However, since this is still a trial, not all potential side effects may be known yet. Participants will receive doses of CDR132L every four weeks, and researchers will closely monitor their safety throughout the study.12345Why are researchers excited about this trial's treatments?
Researchers are excited about CDR132L for heart failure because it targets microRNA-132, a molecule involved in heart disease progression. Unlike standard heart failure treatments like beta-blockers, ACE inhibitors, or diuretics, which mainly manage symptoms and reduce workload on the heart, CDR132L aims to address the underlying molecular causes of heart failure. This unique mechanism could potentially improve heart function and slow disease progression, offering a new hope for patients. Additionally, CDR132L is administered via intravenous infusion, allowing for controlled dosing and potentially enhancing its effectiveness.
What evidence suggests that this trial's treatments could be effective for heart failure?
Research has shown that CDR132L might improve heart function in people with heart failure. Studies have found that this treatment can stop and even reverse changes in the heart that lead to heart failure. CDR132L achieves this by blocking a molecule called microRNA-132, which contributes to harmful changes in the heart. In animal studies, CDR132L improved the heart's pumping and relaxation. Early human results are promising, suggesting that CDR132L could enhance heart performance and structure. Participants in this trial will receive one of three different doses of CDR132L or a placebo, alongside their standard care for heart failure.14678
Who Is on the Research Team?
Clinical Transparency (dept. 2834)
Principal Investigator
Novo Nordisk A/S
Are You a Good Fit for This Trial?
This trial is for individuals with heart failure who have preserved ejection fraction and left ventricular hypertrophy. Specific eligibility criteria are not provided, but typically participants must meet certain health standards to be included.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intravenous infusion of CDR132L or placebo once every 4 weeks for 48 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Extension
Participants continue to be monitored for adverse events up to week 60
What Are the Treatments Tested in This Trial?
Interventions
- CDR132L
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novo Nordisk A/S
Lead Sponsor
Lars Fruergaard Jørgensen
Novo Nordisk A/S
Chief Executive Officer since 2017
MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark
Martin Holst Lange
Novo Nordisk A/S
Chief Medical Officer since 2021
MD from University of Copenhagen