Ongoing, recruitingPhase III and phase IV (Integrated)Interventional

Efficacy of Diltiazem to improve coronary microvascular dysfunction: a randomized clinical trial

The 'Diltiazem for Angina' study is looking into a treatment for people who experience angina, which is chest pain caused by reduced blood flow to the heart. Researchers want to see if a common heart medication called diltiazem can make a difference. Specifically, they are checking if diltiazem improves how the very small blood vessels in the heart function. The study aims to find out if taking diltiazem can correct at least one measurement of these blood vessels’ health, like their ability to widen, without making other measurements worse. This is a crucial step in understanding how to better treat angina caused by problems in these tiny vessels.

At a glance

Status

Ongoing, recruiting

Phase

Phase III and phase IV (Integrated)

Sponsor

Stichting Radboud universitair medisch centrum

Enrolment target

126

Start

04 Apr 2024

Angina

What is this study about?

This study, called 'Diltiazem for Angina', is looking into a common heart condition known as angina. Angina often feels like chest pain or discomfort and happens when your heart muscle isn't getting enough blood. Sometimes, angina is caused by problems with the tiny blood vessels that feed your heart, even if the main arteries are clear. This is called coronary microvascular dysfunction.

The researchers want to see if a medication called diltiazem can help with this type of angina. Diltiazem is already used for various heart conditions, but this study specifically focuses on its effect on those tiny heart blood vessels. They aim to find out if this medicine can improve how these vessels work, which could lead to fewer or less severe angina symptoms.

The main goal is to check if diltiazem successfully treats the problem. They will measure if at least one of the issues with the tiny heart blood vessels gets better, without any normal measurements becoming problematic. Essentially, they're looking for a clear improvement in heart vessel health.

Key takeaways

This study investigates diltiazem for angina caused by tiny heart vessel problems.
It aims to see if diltiazem improves blood flow in these small vessels.
Participation involves taking daily medication (diltiazem or a dummy pill) and regular heart health checks.
The study includes adults aged 18 and over with angina.
You can stop participating at any time without affecting your medical care.

Who may be eligible?

This study is open to both men and women. To take part, you need to be at least 18 years old. There is no upper age limit, meaning older adults can also participate.

The study is specifically for people who have been diagnosed with angina, which is chest pain or discomfort often caused by reduced blood flow to the heart. Your doctor will be able to confirm if you meet the specific medical criteria related to your angina and heart health to ensure this study is right for you, or if you can take part.

More detailed checks will be done by the study team to make sure it's safe and appropriate for you to join. This includes reviewing your medical history and current health status.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a diagnosis of angina (chest pain)?
Are you able to attend regular clinic appointments?
Are you willing to take a study medication daily?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be given either diltiazem or a dummy pill (called cellulose, which has no active medicine) to take regularly. This is a common way to test if the medicine truly works. You won't know which one you're taking, and neither will your local doctor, until the study is over. Your health will be checked regularly through various appointments, which will include tests to measure your heart's blood flow and vessel function. This will involve regular visits to the clinic for assessments and potentially some follow-up calls or shorter appointments. The total duration of your participation, including how long you'll take the medicine and for how many follow-up appointments, will be fully explained by the study team.

Potential risks and benefits

Taking part in this study might mean you see an improvement in your angina symptoms or in how your heart's tiny blood vessels work, especially if you receive the diltiazem and it's effective. You'll also receive careful medical monitoring throughout the study. However, like all medicines, diltiazem can have side effects, and these will be fully explained to you before you agree to take part. There is also a chance you might receive the dummy pill, which means your angina might not improve during the study. You're completely free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What is angina?

Angina is a type of chest pain or discomfort that happens when your heart muscle isn't getting enough blood, usually due to narrowed or blocked blood vessels.

What is diltiazem?

Diltiazem is a medicine commonly used to treat conditions like high blood pressure, irregular heartbeats, and chest pain (angina).

Why is this study important?

This study is important because it's looking for new and better ways to treat angina, especially when it's caused by problems with the tiny blood vessels in the heart, which can be tricky to treat.

Will I know if I'm getting the real medicine?

No, you won't know if you're getting diltiazem or a dummy pill (placebo) until the study has finished. This helps to ensure the results are accurate.

Who can join this study?

Adults aged 18 and over, both men and women, who have angina can be considered for this study. Specific medical details will be checked by the study doctor.