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RecruitingPHASE2INTERVENTIONAL

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

This research study is looking into a potential new medicine called CDR132L for individuals living with a specific type of heart failure. This condition, called Heart Failure with Preserved Ejection Fraction, means your heart struggles to relax properly between beats. The study will test how different doses of CDR132L affect the heart's structure and how well it works, comparing it to a placebo (a treatment with no active medicine). Participants will be randomly assigned to receive either CDR132L or the placebo, meaning it's decided by chance. The total study commitment for volunteers will be approximately 60 weeks. The aim is to understand if CDR132L could be a helpful treatment option.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
Novo Nordisk A/S
Enrolment target
200
Start
27 Jun 2025
Estimated completion
23 Jan 2028

What is this study about?

This research study is focused on a health condition called heart failure. Specifically, it's looking at a type where the heart muscle has become thicker than normal, making it stiff and less able to fill with enough blood. This is known as Heart Failure with Preserved Ejection Fraction (HFpEF) and left ventricular hypertrophy.

The study aims to investigate a new potential medicine, called CDR132L. Researchers want to understand if CDR132L can improve the size and shape of the heart and help it pump blood more effectively. People taking part will either receive CDR132L or a placebo, which is a dummy treatment containing no active medicine. The purpose of using a placebo is to accurately see if any changes are due to the new medicine itself.

By comparing the effects of CDR132L to those of a placebo, doctors can learn whether this new medicine could be a safe and effective way to manage the heart problems experienced by people with this specific type of heart failure. The information gathered will be crucial in deciding if CDR132L should be developed further as a potential treatment.

Key takeaways

  • This study explores a new medicine, CDR132L, for a specific type of heart failure.
  • It aims to improve heart structure and function in people with heart failure and a thickened heart muscle.
  • Participants will receive either the new medicine or a placebo (dummy treatment).
  • The study lasts about 60 weeks and involves regular check-ups and heart scans.
  • Your health will be closely monitored throughout your participation.
  • You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

To join this study, you would need to be between 40 and 84 years old. You should have been diagnosed with ongoing heart failure that causes symptoms for at least three months, and you need to be taking daily water tablets (diuretics). Your heart failure should be stable, and you should be on your usual heart failure medicines without recent changes.

An important part of this study is that your heart's main pumping chamber (left ventricle) needs to be able to pump blood effectively, which doctors will check with a scan. However, this pumping chamber also needs to show signs of being thicker than normal, which will also be measured. Your Body Mass Index (BMI), a measure of weight in relation to height, needs to be between 18.5 and 40, and your total weight should be no more than 140 kg.

There are also some reasons you might not be able to participate. For example, if you have severe kidney problems, or if you've recently had a heart attack or an episode of acute kidney failure. The study doctors will carefully review all your medical information to see if you are a good fit.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you between 40 and 84 years old?
  2. Have you been diagnosed with symptomatic heart failure for at least 3 months?
  3. Do you take water tablets (diuretics) weekly for your heart failure?
  4. Is your heart failure stable and on your usual medicines?
  5. Are you able to attend regular clinic visits for about 15 months?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be involved for approximately 60 weeks, which is about a year and three months. During this time, you would have regular visits to the clinic for check-ups and assessments. The study involves taking either the new medicine, CDR132L, or a placebo, which means a dummy pill with no active ingredients. You won't know which one you're receiving, and it will be decided randomly, like flipping a coin.

At these visits, doctors and nurses will monitor your health closely. This will involve physical examinations, providing blood and urine samples, and having heart scans (like an echocardiogram) to see how your heart's structure and function are changing. These tests help the researchers understand how the potential new medicine is working. You will receive clear instructions on how to take the study medication and what to expect at each appointment.

Potential risks and benefits

Participating in a study like this might offer a potential benefit of receiving a new medicine that could help your heart condition, even if you receive the active drug. However, there's also a chance you could receive the placebo, which means you wouldn't benefit directly from the active medicine. As with any medicine, there's always a possibility of experiencing side effects from CDR132L, or even from the placebo as part of the study process. These will be carefully monitored, and your safety is the top priority. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (109)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Univ of Alabama Birmingham
    Verified postcode
    Birmingham, United States· Recruiting
  • TMC Hlthcr Clin Res Office
    Verified postcode
    Tucson, United States· Not yet recruiting
  • Pima Heart and Vascular
    Verified postcode
    Tucson, United States· Not yet recruiting
  • Valley Clinical Trials
    Verified postcode
    Covina, United States· Recruiting
  • UCSD NAFLD Research Center
    Verified postcode
    La Jolla, United States· Not yet recruiting
  • Valley Clinical Trials
    Verified postcode
    Northridge, United States· Recruiting
  • University of California, San Francisco
    Verified postcode
    San Francisco, United States· Not yet recruiting
  • University of California San Francisco UCSF
    Verified postcode
    San Francisco, United States· Recruiting
  • Harbor-UCLA Medical Center
    Verified postcode
    Torrance, United States· Not yet recruiting
  • CPC Clinical Research & Community Health
    Verified postcode
    Aurora, United States· Not yet recruiting
  • Inpatient Research Clinic LLC
    Verified postcode
    Miami Lakes, United States· Recruiting
  • AdventHealth Orlando
    Verified postcode
    Orlando, United States· Not yet recruiting

Common questions

What is Heart Failure with Preserved Ejection Fraction (HFpEF)?

HFpEF is a type of heart failure where your heart's main pumping chamber works well, but the heart muscle is stiff and thickened, making it harder for the heart to relax and fill with enough blood.

What is a placebo?

A placebo is a 'dummy' treatment that looks like the real medicine but contains no active ingredients. It helps researchers fairly compare the new medicine's effects.

Will I know if I'm getting the active medicine or the placebo?

No, participants in this study won't know whether they are receiving CDR132L or the placebo. This helps prevent bias in the study's results.

How long will I be involved in the study?

The study involves active participation for approximately 60 weeks, which is about 15 months, including regular clinic visits.

What if I want to stop participating?

You are completely free to leave the study at any point, for any reason, and this will not affect your ongoing medical care.

How to find out more

Novo Nordisk

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Research Study Comparing Different Doses of CDR132L With P…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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