Study on the Effects of Bisoprolol and Verapamil in Patients with Non-Obstructive Hypertrophic Cardiomyopathy

3 1 1

What is this study about?

This clinical trial is focused on studying the effects of two medications, Bisoprolol and Verapamil, in patients with a heart condition known as non-obstructive hypertrophic cardiomyopathy. This condition involves the thickening of the heart muscle, which can lead to symptoms like shortness of breath, chest pain, and irregular heartbeats. The purpose of the study is to see how these medications can help reduce symptoms and complications related to this heart condition.

Participants in the study will receive either Bisoprolol, Verapamil, or a placebo. Bisoprolol is a medication that helps lower blood pressure and reduce heart rate, while Verapamil is used to relax the heart muscles and improve blood flow. The study will last for a period of three months, during which the effects of these medications on heart function and symptoms will be monitored. The study aims to measure changes in the heart’s ability to pump blood, the size of the heart chambers, and the occurrence of irregular heartbeats.

Throughout the study, participants will undergo various tests to assess their heart health, including measurements of oxygen consumption and heart volume. The study will also look at how these medications affect the quality of life and symptom severity in patients. By the end of the study, researchers hope to better understand how Bisoprolol and Verapamil can be used to manage symptoms in people with non-obstructive hypertrophic cardiomyopathy.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age and medical history related to non-obstructive hypertrophic cardiomyopathy.

2 initial assessment

An initial assessment is conducted to establish baseline measurements. This includes evaluating maximal oxygen consumption (VO2 max), left ventricular end-diastolic volume, and the incidence of non-sustained ventricular tachycardia.

3 medication administration

Participants receive either Bisoprolol or Verapamil, or a placebo. These medications are administered orally. The dosage and frequency are determined by the study protocol and adjusted based on individual tolerance.

4 ongoing monitoring

Throughout the trial, regular monitoring is conducted to assess the effects of the medication. This includes measuring changes in VO2 max, left ventricular volume, and the occurrence of arrhythmias.

Additional assessments may include questionnaires and various tests such as echocardiography and ambulatory ECG monitoring.

5 final evaluation

At the end of the trial, a final evaluation is performed to compare the initial and final measurements. This helps determine the effectiveness of the treatment in reducing symptoms and complications associated with non-obstructive hypertrophic cardiomyopathy.

Who Can Join the Study?

Must be 18 years or older.
Have a heart wall thickness of 15 mm or more that is not caused by high blood pressure, valve diseases, or storage diseases.
Meet at least one of the following conditions:
- Experience symptoms that are classified as New York Heart Association (NYHA) class II or higher. This means having some limitation in physical activity due to heart symptoms.
- Have a history of NYHA class II or higher before starting treatment with beta-blockers (BB) or calcium channel blockers (CCB). These are types of medications used to treat heart conditions.
- Have a Pro-BNP level greater than 300 ng/l or a BNP level greater than 100 ng/l. These are blood tests that measure substances released by the heart when it is under stress.
- Have experienced non-sustained ventricular tachycardia (VT), which is a fast heart rhythm, with a rate of more than 120 beats per minute and lasting for at least 3 cycles, documented within the last 2 years.
Both male and female participants are eligible.
Participants should not belong to a vulnerable population.

Who Cannot Join the Study?

Patients with other types of heart conditions that are not related to non-obstructive hypertrophic cardiomyopathy cannot participate. This is a specific heart condition where the heart muscle becomes thick but does not block blood flow.
Individuals who are not within the specified age range for the study are excluded. The study is only for certain age groups.
Participants who are not able to safely take the study medications, such as Bisoprolol and Verapamil, are not eligible. These are medications used to manage heart conditions.
People with certain medical conditions that might interfere with the study or make it unsafe for them to participate are excluded.
Individuals who are part of a vulnerable population, meaning they might need special protection or care, are not included in the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country
Sjællands Universitetshospital	Roskilde	Denmark
Regionshospitalet Viborg	Viborg	Denmark
Odense University Hospital	Odense	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	05.04.2022

Trial locations

Investigated drugs:

Bisoprolol is a medication used in this trial to help manage symptoms in patients with non-obstructive hypertrophic cardiomyopathy. It works by slowing down the heart rate and reducing the heart’s workload, which can help improve the heart’s efficiency and reduce symptoms like shortness of breath and chest pain.

Verapamil is another medication involved in the trial. It is used to help control heart rate and rhythm. Verapamil can help relax the heart muscles and blood vessels, which may improve blood flow and reduce the risk of arrhythmic complications in patients with non-obstructive hypertrophic cardiomyopathy.

Investigated diseases:

Hypertrophic cardiomyopathy

Non-obstructive hypertrophic cardiomyopathy – This is a condition where the heart muscle becomes abnormally thick without any blockage in the blood flow. The thickened heart muscle can make it harder for the heart to pump blood efficiently. Over time, this can lead to symptoms such as shortness of breath, chest pain, and palpitations. The disease can also cause arrhythmias, which are irregular heartbeats. It is a genetic condition, often inherited, and can vary greatly in severity among individuals. The progression of the disease can lead to changes in heart function and structure, affecting overall cardiovascular health.

Trial ID:

2024-515346-17-00

NCT ID:

NCT05569382

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on the Effects of Bisoprolol and Verapamil in Patients with Non-Obstructive Hypertrophic Cardiomyopathy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?