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Study on Early Use of Candesartan vs Placebo for People with Genetic Risk of Dilated Cardiomyopathy

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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 heart condition known as dilated cardiomyopathy (DCM). DCM is a disease where the heart becomes enlarged and cannot pump blood efficiently. The study is specifically looking at individuals who carry genetic variants that can cause DCM but do not yet show symptoms of the disease. The treatment being tested is a medication called candesartan, which is commonly used to treat high blood pressure and heart failure. In this trial, candesartan is being compared to a placebo to see if it can prevent changes in the heart that are associated with DCM.

The purpose of the study is to determine if early treatment with candesartan can prevent a significant decline in the heart's ability to pump blood, known as left ventricular ejection fraction (LVEF), or an increase in the size of the heart's main pumping chamber, known as left ventricular end-diastolic volume (LVEDV). Participants in the study will be randomly assigned to receive either candesartan or a placebo. The study will monitor changes in LVEF and LVEDV over time using magnetic resonance imaging (MRI), a type of scan that provides detailed images of the heart.

The trial will last for several years, during which participants will have regular check-ups and MRI scans to track any changes in their heart function. The study aims to see if candesartan can help prevent the progression of DCM in people who are at risk but do not yet have symptoms. This research could provide valuable insights into the early treatment of DCM and potentially improve outcomes for those with a genetic predisposition to the disease.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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 and genetic factors related to dilated cardiomyopathy.
You will undergo a magnetic resonance imaging (MRI) scan to measure your heart's function and structure. This will help establish a baseline for your heart's performance.
Step 2
Medication administration
You will be randomly assigned to receive either the active medication, candesartan cilexetil, or a placebo. The active medication is available in two dosages: 8 mg and 16 mg tablets.
The medication is taken orally, once daily. The duration of administration will continue throughout the study period, which is estimated to end by June 2028.
Step 3
Regular follow-up visits
You will attend regular follow-up visits to monitor your health and the effects of the medication. These visits will include assessments of your heart function using MRI scans.
The primary goal is to observe any changes in your heart's performance, specifically looking for any significant decline in heart function or increase in heart size.
Step 4
End of study evaluation
At the end of the study, a final evaluation will be conducted. This will include a comprehensive assessment of your heart's function and structure using MRI.
The results will help determine the effectiveness of early treatment with candesartan in preventing heart deterioration in individuals with genetic predispositions to dilated cardiomyopathy.

Who can join the trial?

5 criteria

Age between 18 and 64 years old, including both men and women.
Must be a carrier of a genetic variant that can cause dilated cardiomyopathy (DCM). This means you have a specific change in your genes that might lead to this heart condition.
Your heart's pumping ability, known as Left Ventricular Ejection Fraction (LVEF), must be 50% or higher. This will be measured by an MRI scan. If you have myocardial fibrosis (a type of heart tissue change) detected by a special MRI technique, you can still participate.
Your blood tests must show a potassium level of 5.3 mEq/L or lower, a creatinine level of 1.3 mg/dL or lower, and an estimated Glomerular Filtration Rate (eGFR) of 60 ml/min/1.73 m² or higher. These are measures of kidney function and electrolyte balance.
You must be able to understand the study requirements and agree to participate by providing informed consent.

Who cannot join the trial?

6 criteria

Patients who are not genetic carriers of dilated cardiomyopathy causing variants cannot participate. A genetic carrier is someone who has a gene that can cause a disease, even if they do not show symptoms.
Patients who have already shown signs of the disease cannot participate. This study is for those without disease expression.
Patients under the age of 18 cannot participate. The study is for adults only.
Patients who are pregnant or breastfeeding cannot participate.
Patients with any other serious health conditions that might interfere with the study cannot participate.
Patients who are unable to follow the study procedures cannot participate.

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Verified sites

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Verified
Amsterdam UMC
Amsterdam, The Netherlands
Responsive
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, The Netherlands
Responsive
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
Barcelona, Spain

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Investigated drugs

Candesartan is a medication that is often used to treat high blood pressure and heart failure. In this clinical trial, it is being tested to see if it can help prevent heart problems in people who have a genetic risk for a type of heart disease called Dilated Cardiomyopathy (DCM). The goal is to see if taking candesartan early can stop or slow down changes in the heart that could lead to this disease. Specifically, the trial is looking at whether candesartan can prevent a decrease in how well the heart pumps blood or an increase in the size of the heart's chambers. This medication works by helping to relax blood vessels, which can make it easier for the heart to pump blood and reduce the strain on the heart.

Candesartan Cilexetil

What is already known about the treatment

Candesartan – Candesartan is taken orally in the form of a tablet. It is currently being studied in clinical trials to see if it can help prevent heart problems in people who carry certain genetic markers for dilated cardiomyopathy, a condition that affects the heart's ability to pump blood. The main use of candesartan is to manage high blood pressure and heart failure. It works by blocking a substance in the body that causes blood vessels to tighten, allowing them to relax and lower blood pressure. Candesartan belongs to a group of drugs known as angiotensin II receptor blockers (ARBs).

Investigated diseases

Dilated Cardiomyopathy – Dilated cardiomyopathy is a condition where the heart's main pumping chamber, the left ventricle, becomes enlarged and weakened. This enlargement leads to a decrease in the heart's ability to pump blood efficiently, which can cause symptoms like fatigue and shortness of breath. Over time, the heart's ability to pump blood worsens, potentially affecting other parts of the heart. The disease can progress slowly or rapidly, and its progression can vary widely among individuals. It is often caused by genetic factors, infections, or exposure to toxins. The condition can lead to complications such as heart rhythm problems or heart failure if it continues to progress.