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Study on the Effect of Diltiazem on Angina in Patients with Coronary Microvascular Dysfunction

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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 the effects of a medication called diltiazem hydrochloride on a condition known as coronary microvascular dysfunction, which is a type of heart problem that affects the small blood vessels in the heart. People with this condition often experience chest pain, known as angina, even though their larger heart arteries are not blocked. The trial aims to see if diltiazem can improve the function of these small blood vessels and help reduce symptoms in patients who have been experiencing angina regularly despite other treatments.

Participants in the study will be given either diltiazem or a placebo, which is a substance with no active medication. The study will last for a period of up to six months. During this time, the effects of diltiazem on the heart's small blood vessels will be closely monitored. The goal is to determine if diltiazem can help normalize the function of these vessels without causing any of the normal parameters to become abnormal.

The study will assess the success of the treatment by checking if at least one of the abnormal heart function parameters returns to normal. These parameters include measures like the Index of Microcirculatory Resistance (IMR) and the Coronary Flow Reserve (CFR). A successful treatment would mean that patients experience fewer symptoms of angina and improved heart function. The trial is expected to continue until 2026, providing valuable insights into the potential benefits of diltiazem for patients with coronary microvascular dysfunction.

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
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria. Participants must be over 18 years old and have experienced chronic angina at least twice a week for the past three months despite medical treatment.
Participants must have no signs of obstructive coronary artery disease, confirmed by specific tests within the last five years.
Step 2
Baseline testing
Initial tests are conducted to assess coronary function. These tests include measuring coronary flow reserve (CFR), index of microcirculatory resistance (IMR), and an acetylcholine test to check for angina and other symptoms.
Step 3
Medication administration
Participants receive a medication called Diltiazem HCl Auro retard, which is a modified-release tablet taken orally. The dosage is 120 mg.
The medication is administered to evaluate its effect on coronary microvascular function.
Step 4
Ongoing assessment
Throughout the trial, participants undergo regular assessments to monitor the effects of the medication. These assessments focus on changes in coronary function parameters.
Step 5
Completion of the trial
The trial aims to determine the proportion of participants who experience successful treatment with diltiazem. Success is defined as the normalization of at least one abnormal parameter without any normal parameters becoming abnormal.
The trial is expected to conclude by May 1, 2026.

Who can join the trial?

8 criteria

Patients must be over the age of 18.
Patients should have chronic angina, which means they experience chest pain at least twice a week despite taking medication for the last 3 months.
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Patients should not have signs of obstructive coronary artery disease (CAD), which means their heart arteries are not significantly blocked. This should be documented within the last 5 years using one of the following methods:
- Non-obstructive coronary arteries, meaning less than 50% blockage, or arteries with 50-70% blockage but with a test result showing good blood flow (FFR > 0.80 or iFR > 0.89).
- A heart scan called coronary computed tomography angiography (CCTA) showing non-obstructive coronary arteries.
- check
  Patients must have a baseline test of their heart's blood flow with at least one of the following results:
  - CFR (a measure of blood flow) less than or equal to 2.0.
  - IMR (a measure of resistance in small heart vessels) greater than or equal to 25.
  - An abnormal acetylcholine test, which means experiencing chest pain or changes in heart rhythm during the test, with or without a spasm in the heart's main arteries.
  - Patients must sign a written informed consent form, which means they agree to participate in the study after understanding all the details.

Who cannot join the trial?

3 criteria

Patients who have a history of angina, which is a type of chest pain caused by reduced blood flow to the heart.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, meaning they may have additional health or social challenges that could affect their participation.

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Verified sites

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Verified
Catharina Ziekenhuis Stichting
Eindhoven, The Netherlands
Responsive
Stichting Radboud University Medical Center
Nijmegen, The Netherlands

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Investigated drugs

Diltiazem is a medication used in this trial to improve coronary microvascular function. It is often prescribed to help with heart-related conditions by relaxing the blood vessels, which can improve blood flow and reduce the heart's workload. In this study, researchers are examining how well diltiazem works in patients who have symptoms of coronary microvascular dysfunction, a condition where the small blood vessels in the heart don't work as they should.

What is already known about the treatment

Diltiazem – Diltiazem is typically administered orally in tablet form or intravenously in a hospital setting. It is currently well-established in medical literature as a treatment for various heart conditions, including angina. The main therapeutic indication for diltiazem is to relieve chest pain by improving blood flow to the heart. At the molecular level, it works by blocking calcium channels in the heart and blood vessels, which helps to relax the muscles and improve blood flow. Diltiazem is classified as a calcium channel blocker in pharmacology.

Investigated diseases

Angina – Angina is a condition characterized by chest pain or discomfort that occurs when the heart muscle does not receive enough oxygen-rich blood. It often feels like pressure or squeezing in the chest and can also occur in the shoulders, arms, neck, jaw, or back. Angina is typically triggered by physical exertion or stress and usually lasts for a few minutes. It is a symptom of an underlying heart problem, often coronary artery disease, where the arteries supplying blood to the heart become narrowed or blocked. Angina can be stable, occurring predictably with activity, or unstable, occurring unpredictably and possibly signaling a more serious heart condition. Understanding and managing angina involves recognizing its triggers and symptoms to prevent further heart complications.