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Study on the Effects of Perindopril, Valsartan, and Glyceryl Trinitrate in Women with Asymptomatic Heart Failure

Verified siteRegistered drugNo placebo

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What is this trial about?

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

The TREASURE trial is focused on studying subclinical heart failure, a condition where the heart shows early signs of not working properly, but without noticeable symptoms. The study will explore the effects of a medication called Perindopril, which is an angiotensin-converting-enzyme (ACE) inhibitor. This medication is commonly used to help manage heart conditions by relaxing blood vessels and reducing blood pressure. The trial will compare the effects of Perindopril to usual care, which means no medication, over a period of two years.

Participants in the study will be women who have early-stage heart failure or a condition known as diastolic dysfunction, where the heart has trouble relaxing and filling with blood. The study aims to see if using Perindopril can help reverse changes in the heart that occur in these conditions, bringing them closer to healthy values. The trial will also involve monitoring other aspects of health, such as blood pressure and quality of life, to understand the broader effects of the treatment.

During the study, participants will take Perindopril in the form of tablets, and their progress will be observed over the two-year period. The goal is to gather information on how effective the medication is in improving heart health and overall well-being in women with early signs of heart failure. This research could provide valuable insights into managing heart conditions before they become more serious.

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 assessment
Upon joining the study, you will undergo an initial assessment to confirm eligibility. This includes reviewing your medical history and conducting necessary tests to ensure you meet the study criteria.
Step 2
Medication introduction
You will begin taking the study medications. The medications include valsartan 40 mg capsules taken orally, perindopril 2 mg tablets taken orally, and nitrospray 0.4 mg used as a sublingual spray. The specific dosage and frequency will be explained to you by the study team.
The duration of medication administration is two years, during which you will be monitored regularly.
Step 3
Regular monitoring
Throughout the study, you will have regular check-ups to monitor your health and the effects of the medication. This includes measuring blood pressure, assessing heart function, and evaluating overall well-being.
These check-ups are crucial to ensure your safety and to gather data on the effectiveness of the treatment.
Step 4
Follow-up assessments
At various points during the study, follow-up assessments will be conducted to evaluate changes in heart function and other health parameters. This helps in understanding the impact of the treatment on your condition.
Step 5
Final evaluation
At the end of the two-year period, a final evaluation will be conducted. This will include a comprehensive review of your health status and the outcomes of the treatment.
The results will contribute to the study's objective of assessing the treatment's effectiveness in reversing heart changes associated with subclinical heart failure.

Who can join the trial?

5 criteria

Must be a woman aged 18 years or older.
Must have heart failure stage-B or diastolic dysfunction (a condition where the heart has difficulty relaxing and filling with blood).
Must be premenopausal (before menopause), with or without a history of preeclamptic pregnancy (a condition during pregnancy characterized by high blood pressure).
Must be between ½ and 30 years after the first complicated pregnancy.
The last delivery must have been at least 6 months ago.

Who cannot join the trial?

4 criteria

Patients who are not women cannot participate.
Patients who have symptoms of heart failure cannot participate. Heart failure is a condition where the heart does not pump blood as well as it should.
Patients who are taking medications that are not part of the study cannot participate.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups like children, pregnant women, or people who cannot make decisions for themselves.

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Verified sites

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University Hospital Maastricht
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Maastricht, The Netherlands

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Investigated drugs

Angiotensin-Converting Enzyme (ACE) Inhibitor is a type of medication used in this clinical trial. It helps relax blood vessels, making it easier for the heart to pump blood. This medication is being tested to see if it can help reverse changes in the heart that occur in women with a condition called asymptomatic heart failure. The goal is to see if the heart can return to a healthier state when using this medication compared to not using any medication at all.

What is already known about the treatment

Angiotensin-Converting Enzyme (ACE) Inhibitor – This medication is taken orally, usually in the form of a pill, and is used to help manage heart conditions. It is currently being studied for its effectiveness in treating subclinical heart failure, which is a stage of heart failure where symptoms are not yet apparent. The main therapeutic use of ACE inhibitors is to help the heart work more efficiently by relaxing blood vessels, which lowers blood pressure and reduces the heart's workload. At the molecular level, ACE inhibitors block the enzyme that narrows blood vessels, improving blood flow and reducing strain on the heart. They are classified as antihypertensive agents, which means they are primarily used to treat high blood pressure.

Investigated diseases

Subclinical Heart Failure – Subclinical heart failure is a condition where the heart shows signs of dysfunction but without the typical symptoms of heart failure. It involves changes in the heart's structure, such as left ventricular hypertrophy, which is an increase in the size of the heart's left ventricle. The heart may also exhibit concentric remodeling, where the walls of the heart become thicker without an increase in overall size. There can be impaired systolic function, meaning the heart's ability to contract and pump blood is reduced. Significant valve dysfunction may occur, affecting the heart's ability to regulate blood flow. Additionally, there may be signs of a past myocardial infarction, indicating previous damage to the heart muscle.