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Study on the Effects of CDR132L on Heart Structure and Function in Patients with Heart Failure and Left Ventricular Hypertrophy

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Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie
Lublin, Poland
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Heart Failure with Preserved Ejection Fraction (HFpEF) and Left Ventricular Hypertrophy (LVH). These are heart conditions where the heart muscle is thickened and the heart's ability to pump blood is affected, but the heart's pumping capacity remains normal. The study will test a treatment called CDR132L, which is a type of medication made from nucleic acids, a basic building block of life. The trial will compare different doses of CDR132L with a placebo to see how they affect the heart's structure and function in people with these conditions.

The purpose of the study is to see if CDR132L can improve heart health by changing certain markers in the blood, specifically something called miR-132, over a period of 24 weeks. Participants will receive either CDR132L or a placebo, in addition to their usual heart failure treatments. The study will monitor changes in the heart's structure and function, as well as any side effects, over the course of the trial.

Participants will be involved in the study for up to 60 weeks, during which they will have regular check-ups to assess their heart health and overall well-being. The study aims to provide valuable information on whether CDR132L can be a beneficial treatment for people with HFpEF and LVH, potentially leading to better management of these heart conditions in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, an initial visit is scheduled. During this visit, eligibility is confirmed based on specific criteria such as age, heart function, and overall health status.
A series of tests, including echocardiography, are conducted to assess heart function and structure. These tests help establish a baseline for the study.
Step 2
Randomization
Participants are randomly assigned to receive either the study medication, CDR132L, or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.
The study medication or placebo is administered every four weeks (Q4W) in addition to standard heart failure care.
Step 3
Treatment phase
The treatment phase lasts for 24 weeks. During this time, regular visits are scheduled to monitor health and response to the treatment.
Participants receive the assigned treatment every four weeks. Health assessments and tests are conducted at each visit to track changes in heart function and structure.
Step 4
Follow-up visits
After the 24-week treatment phase, follow-up visits continue until week 60 to monitor long-term effects and any adverse events.
These visits include health assessments and may involve additional tests to ensure participant safety and gather comprehensive data on the treatment's impact.
Step 5
End of study
The study concludes with a final assessment to evaluate the overall effects of the treatment on heart function and structure.
Participants are provided with information about the study's findings and any relevant health recommendations.

Who can join the trial?

8 criteria

Age between 40 and 84 years old at the time of signing the consent form.
Have a documented history of symptomatic heart failure diagnosed at least 90 days before the screening. This means you need to have symptoms of heart failure and require oral diuretic treatment at least once a week. You should also be in New York Heart Association class II or III at screening, which indicates the severity of your heart failure symptoms.
Be clinically stable and on optimized doses of heart failure medication for at least 30 days before joining the study. This means your medication should not have changed during this time.
Have a left ventricular ejection fraction of 50% or higher. This is a measure of how well your heart is pumping blood, assessed by an ultrasound of the heart.
For women, have a left ventricular mass index (LVMi) greater than 88 g/m², and for men, greater than 102 g/m². This is a measure of the size of the heart muscle, assessed by an ultrasound of the heart.
Have a left atrial volume index (LAVi) of 29 mL/m² or higher. This is a measure of the size of one of the chambers of the heart, assessed by an ultrasound of the heart.
Have a body mass index (BMI) between 18.5 and 40 kg/m² and a body weight of 140 kg or less. BMI is a measure of body fat based on height and weight.
Have a NT-proBNP level of 300 pg/mL or higher. If you have atrial fibrillation/flutter (a type of irregular heartbeat), the level should be 600 pg/mL or higher. This is a blood test that helps to assess heart failure.

Who cannot join the trial?

8 criteria

Patients with a history of severe allergic reactions to the study medication.
Patients who have had a heart attack in the last 3 months.
Patients with uncontrolled high blood pressure.
Patients with severe kidney disease.
Patients with severe liver disease.
Patients who are pregnant or breastfeeding.
Patients currently participating in another clinical trial.
Patients with any other medical condition that the study doctors think would make it unsafe to participate.

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Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie
Lublin, Poland
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Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain
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Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
Warsaw, Poland

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Investigated drugs

CDR132L is an experimental medication being studied for its potential to help people with a specific type of heart failure. This heart failure is known as heart failure with preserved ejection fraction, where the heart's pumping ability is normal, but the heart muscle is thickened. The medication is designed to target and reduce the levels of a molecule called miR-132 in the body. By doing this, it aims to improve the heart's structure and function, potentially leading to better outcomes for patients with this condition. The study is investigating whether adding CDR132L to the usual treatments for heart failure can provide additional benefits.

What is already known about the treatment

CDR132L – CDR132L is administered as an injection, given once every four weeks, and is currently being studied in clinical trials for its potential benefits in treating heart failure with preserved ejection fraction and left ventricular hypertrophy. This medication is still under investigation, and its effectiveness and safety are being evaluated in medical research. The main goal of using CDR132L is to help improve heart function in patients with specific types of heart failure. It works by targeting and reducing levels of a molecule called miR-132, which is involved in heart disease, aiming to improve heart structure and function. CDR132L is classified as an investigational drug, meaning it is not yet approved for general medical use.

Investigated diseases

Heart Failure with Preserved Ejection Fraction and Left Ventricular Hypertrophy – This condition involves the heart's inability to pump blood efficiently despite having a normal ejection fraction, which is the percentage of blood leaving the heart each time it contracts. In this type of heart failure, the heart muscle is often thickened, a condition known as left ventricular hypertrophy. This thickening can make it harder for the heart to fill with blood, leading to symptoms such as shortness of breath and fatigue. Over time, the heart's ability to relax and fill with blood becomes increasingly impaired. This can result in fluid buildup in the lungs and other parts of the body. The progression of this condition can lead to increased difficulty in performing physical activities.