Study on CDR132L for Heart Failure with Reduced Ejection Fraction and Left Ventricular Hypertrophy in Adults

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What is this study about?

This clinical trial is focused on studying heart failure in individuals who have a reduced or mildly reduced ability of the heart to pump blood, known as ejection fraction, along with a condition called left ventricular hypertrophy, which is a thickening of the heart’s main pumping chamber. The study will test a treatment called CDR132L, which is a type of nucleic acid therapy. This treatment will be compared to a placebo to see how it affects the heart’s structure and function.

The purpose of the study is to determine if CDR132L is more effective than a placebo in improving heart health in participants. The study will last for several months, during which participants will receive either the CDR132L treatment or a placebo, in addition to their usual heart failure care. The main focus will be on changes in a specific molecule called miR-132 over a 24-week period. Participants will be monitored for any changes in their heart condition and any side effects they may experience.

Throughout the study, participants will undergo regular check-ups to assess their heart’s function and overall health. The study aims to provide valuable information on the potential benefits of CDR132L for people with heart failure and left ventricular hypertrophy, contributing to better treatment options in the future.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, your eligibility will be confirmed based on specific criteria such as age, heart function, and overall health status.

You will undergo tests like echocardiography to assess your heart’s structure and function. Your body mass index and weight will also be measured.

2 randomization

After confirming eligibility, you will be randomly assigned to receive either the study medication, CDR132L, or a placebo. A placebo is a substance with no active medication, used for comparison.

This process is double-blind, meaning neither you nor the study team will know which treatment you are receiving.

3 treatment phase

You will receive the assigned treatment every four weeks (Q4W) for a total of 24 weeks. The dosage for CDR132L is 00 mg/kg.

During this phase, you will continue with your standard heart failure care as prescribed by your healthcare provider.

4 follow-up visits

Throughout the study, you will have regular follow-up visits to monitor your health and the effects of the treatment.

These visits will include assessments of your heart function and any side effects you may experience.

5 end of treatment assessment

At the end of the 24-week treatment period, a final assessment will be conducted to evaluate changes in your heart’s structure and function.

This will include measuring specific markers in your blood and conducting imaging tests.

6 extended follow-up

After the treatment phase, you will continue to be monitored for any long-term effects or adverse events until week 60.

This extended follow-up ensures your safety and helps gather comprehensive data on the treatment’s impact.

Who Can Join the Study?

Age between 40 and 84 years old.
Have a documented history of heart failure symptoms for at least 180 days before the screening, requiring at least weekly use of oral diuretics (medications that help remove excess fluid from the body). Must be classified as New York Heart Association class II or III, which means experiencing some limitations in physical activity.
Be clinically stable and on optimized doses of heart failure medications for at least 30 days before joining the study.
Have a left ventricular ejection fraction (LVEF) of less than 50% as measured by an echocardiogram. LVEF is a measure of how well the heart pumps blood.
Have a left ventricular mass index (LVMi) greater than 88 g/m² for women and greater than 102 g/m² for men, as measured by an echocardiogram. LVMi is a measure of the size of the heart muscle.
Have a left atrial volume index (LAVi) of 29 mL/m² or more, as measured by an echocardiogram. LAVi is a measure of the size of the left atrium 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 level of NT-proBNP of 300 pg/mL or more, or 600 pg/mL or more if atrial fibrillation or flutter is present. NT-proBNP is a blood test that helps measure the severity of heart failure.

Who Cannot Join the Study?

Patients with a history of severe allergic reactions to any of the study medications.
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 who are currently participating in another clinical trial.
Patients with any other medical condition that the study doctors think would make it unsafe to participate.

Where you can join this trial?

Verified and Recommended Sites

Site Name	City	Country	Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie	Lublin	Poland

Verified Sites

Site Name	City	Country
Medizinische Hochschule Hannover	Hanover	Germany
Zuyderland Medisch Centrum Stichting	Geleen	The Netherlands
4 Wojskowy SzpitaKliniczny Z Polikliniką Samodzielny Publiczny ZakładOpieki ZdrowotneWe Wrocławiu	Wroclaw	Poland
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Osrodek Badan Klinicznych Przy Szpitalu Specjalistycznym Im. Ludwika Rydygiera W Krakowie Sp. z o.o.	Cracow	Poland
Technische Universitaet Dresden	Dresden	Germany
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland
Pomeranian Medical University	Szczecin	Poland

Other Sites

Site Name	City	Country
Pratia Prague s.r.o.	Prague	Czechia
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Del Mar	Barcelona	Spain
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy	Warsaw	Poland
Stichting Viecuri Medisch Centrum voor Noord-Limburg	Venlo	The Netherlands
El Hospital Universitario De Gran Canaria Dr. Negrin	Las Palmas De Gran Canaria	Spain
Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej	Biala Podlaska	Poland
Uniwersytecki Szpital Kliniczny W Bialymstoku	Bialystok	Poland
Virgen del Rocío University Hospital	Sevilla	Spain
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Stichting Radboud University Medical Center	Nijmegen	The Netherlands
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Hospital Universitari De Girona Doctor Josep Trueta	Girona	Spain
American Heart Of Poland S.A.	Kedzierzyn-Kozle	Poland
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
1 Wojskowy Szpital Kliniczny Z Poliklinika samodzielny publiczny zakład opieki zdrowotnej W Lublinie	Lublin	Poland
University Hospital Ostrava	Ostrava	Czechia
Nemocnice Ceske Budejovice a.s.	Ceske Budejovice	Czechia
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Upxnozuvpaumhpbhppyyu Esfdl Ads	Essen	Germany
Iqcowsula Fpo Citzdpdm Azp Etptikazgcub Mnetpkdx	Prague	Czechia
Hejkdocj ds Dbamc	Denia	Spain
Ekxrrez Uvjquvvmqnoi Mswcatm Crkukvc Rllafjgzw (gvcmuhm Mxu	Rotterdam	The Netherlands
Almaoirnt Uuv	Amsterdam	The Netherlands
Mzkejgaiyonmiorlbwpxpyqldm Hoyvzqvqbnucxsdf	Halle (Saale)	Germany
Fbnwonmaw Pgpw Lm Ifrllbwgqexqv Bbnwersfp Djk Hgocqblz Uebgbarndfbns Ls Pnx	Madrid	Spain
Gnhmfp Umivdmoozp Ftnjxlawj	Frankfurt	Germany
Wohqlmgboa Sdkhhqv Iio Sesgcta Pey W Pidmbdgxv	Przemysl	Poland
Kysyfmhbn Smlmcaj Sofqcsuhxqneefh ia Jpyu Pgxdl Ip	Cracow	Poland

Trial status

Country	Status	Recruitment Start
Czechia	Recruiting	01.07.2025
Germany	Recruiting	01.07.2025
Poland	Recruiting	01.07.2025
Spain	Recruiting	01.07.2025
The Netherlands	Recruiting	01.07.2025

Trial locations

CDR132L is an experimental medication being studied for its potential to help people with heart failure. Heart failure is a condition where the heart doesn’t pump blood as well as it should. This medication is designed to target a specific molecule in the body called miR-132, which is thought to play a role in heart problems. By affecting this molecule, CDR132L aims to help improve the heart’s function and structure, potentially leading to better outcomes for patients with heart failure. In this study, CDR132L is being tested to see if it can help reverse changes in the heart that occur with heart failure, especially in people whose heart muscle has become thicker than normal.

Investigated diseases:

Cardiac failure

Heart Failure with Reduced Ejection Fraction – This condition occurs when the heart muscle is unable to pump blood effectively, leading to a decrease in the amount of blood ejected from the heart with each beat. Over time, the heart’s ability to pump diminishes, causing symptoms such as fatigue, shortness of breath, and fluid retention. The heart chambers may become enlarged, and the walls of the heart may thicken. As the condition progresses, the heart’s pumping capacity continues to decline, which can lead to further complications. The reduced ejection fraction is a key indicator of the severity of the condition. Management focuses on improving heart function and alleviating symptoms.

Heart Failure with Mildly Reduced Ejection Fraction – This condition is characterized by a slightly reduced ability of the heart to pump blood, with an ejection fraction that is lower than normal but not as severely reduced as in other forms of heart failure. Symptoms may include mild fatigue, shortness of breath, and some fluid retention. The heart’s pumping ability is compromised, but the reduction in ejection fraction is less pronounced. Over time, the heart may struggle to meet the body’s demands, leading to a gradual worsening of symptoms. The condition requires monitoring to prevent further decline in heart function. Management aims to support heart health and maintain quality of life.

Left Ventricular Hypertrophy – This condition involves the thickening of the walls of the heart’s left ventricle, which is the main pumping chamber. The thickened heart muscle can become stiff, reducing the heart’s ability to fill with blood and pump efficiently. Over time, this can lead to increased pressure in the heart and reduced blood flow to the body. Symptoms may not be immediately apparent but can include chest pain, dizziness, and shortness of breath. The condition often develops as a response to high blood pressure or other heart-related issues. Monitoring and management focus on addressing the underlying causes and preventing further heart damage.

Trial ID:

2024-515797-27-00

Protocol code:

NN6706-8282

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on CDR132L for Heart Failure with Reduced Ejection Fraction and Left Ventricular Hypertrophy in Adults

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?