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Study on the Effects of Vericiguat on Patients with Vasospastic Angina

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

This clinical trial is focused on studying the effects of a medication called Vericiguat on a condition known as Vasospastic Angina. Vasospastic Angina is a type of chest pain caused by spasms in the heart's blood vessels, which can lead to reduced blood flow to the heart. The study aims to understand how Vericiguat affects the small blood vessels in patients with this condition. Vericiguat is taken in the form of film-coated tablets and is being compared to a placebo to evaluate its effectiveness.

Participants in the study will receive either Vericiguat or a placebo over a period of several weeks. The study will assess changes in the function of small blood vessels using a method called Laser Speckle Contrast Analysis (LASCA), which is a technique to visualize blood flow. The study will also look at how Vericiguat affects the quality of life and the frequency of angina attacks in participants. The trial will involve different doses of Vericiguat to determine the most effective dose for improving symptoms.

In addition to Vericiguat, the study will also involve the use of other substances like Insulin Aspart and Sodium Nitroprusside Dihydrate to further explore their effects on blood vessel function. The trial is designed to provide valuable insights into the treatment of Vasospastic Angina and aims to improve the management of this condition for patients in the future.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Beginning of the trial
Upon joining the study, you will be informed about the trial's purpose and procedures. You will be asked to provide consent to participate.
You will undergo initial assessments to confirm eligibility, including a review of your medical history and current health status.
Step 2
Baseline assessments
Baseline measurements will be taken to assess your current health condition. This may include blood tests, heart function tests, and other relevant evaluations.
These assessments are crucial to establish a starting point for the study.
Step 3
Treatment phase 1
You will begin the first treatment phase, which involves taking a **placebo**. A placebo is a substance with no active medication, used to compare against the actual drug.
This phase will last for 10 weeks. You will be required to take the placebo as instructed, typically once daily.
Step 4
Mid-study assessments
After the first 10-week period, you will undergo assessments similar to the baseline to evaluate any changes in your condition.
These assessments will help determine the effects of the placebo.
Step 5
Treatment phase 2
You will begin the second treatment phase, which involves taking **vericiguat**. Vericiguat is the medication being tested in this study.
This phase will also last for 10 weeks. You will be required to take vericiguat as instructed, typically once daily. The dosage may vary between 2.5 mg, 5 mg, or 10 mg, depending on the study protocol.
Step 6
End-of-study assessments
At the end of the second 10-week period, you will undergo final assessments to evaluate the effects of vericiguat on your condition.
These assessments will include similar tests to those conducted at the baseline and mid-study points.
Step 7
Completion of the trial
Once all assessments are completed, your participation in the study will conclude.
You will receive information about the study's findings and any relevant follow-up care if necessary.

Who can join the trial?

12 criteria

Must be older than 18 years.
Experience recurring chest pain (angina) triggered by exercise or have frequent chest pain attacks at rest at least once a week, even with current medical treatment.
Must not have significant narrowing of the coronary arteries, which are the blood vessels supplying the heart. This means no artery is narrowed by more than 50%, or specific tests show no significant blockage.
Must have clear evidence of coronary vasospasm, which is a temporary narrowing of the coronary arteries, confirmed by a specific medical test called invasive acetylcholine provocation testing.
check
If female, must meet one of the following conditions:
- Be in a confirmed post-menopausal state, meaning no menstrual periods for at least 12 months without another medical reason.
- If premenopausal, must have had a hysterectomy (removal of the uterus), bilateral salpingectomy (removal of both fallopian tubes), or bilateral oophorectomy (removal of both ovaries).
- check
  If of childbearing potential, must have a negative pregnancy test within 24 hours before the first dose of the study drug and use a highly effective birth control method during the study and for at least one month after the last dose. Effective methods include:
  - Progestogen-only subdermal contraceptive implant
  - Intrauterine system (progestin-releasing device)
  - Non-hormonal intrauterine device
  - Bilateral tubal occlusion (blocking of fallopian tubes)
  - Partner with no sperm (due to vasectomy or medical reasons)
  - Heterosexual abstinence

Who cannot join the trial?

8 criteria

Patients with other heart conditions that are not related to **vasospastic angina**. Vasospastic angina is a type of chest pain caused by spasms in the heart's blood vessels.
Patients who have had a recent heart attack or other serious heart events.
Patients with severe liver or kidney disease.
Patients who are pregnant or breastfeeding.
Patients who are currently participating in another clinical trial.
Patients with a history of drug or alcohol abuse.
Patients who are unable to follow the study procedures or attend study visits.
Patients with any condition that the study doctors believe would make it unsafe for them to participate.

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Verified
Amsterdam UMC
Amsterdam, The Netherlands

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Investigated drugs

Vericiguat is a medication being studied for its potential benefits in people with vasospastic angina, a condition where the heart's blood vessels spasm and cause chest pain. The trial aims to see how well vericiguat can improve the function of small blood vessels in the heart. This is done using a special technique called laser speckle contrast analysis, which helps doctors see how blood flows through these tiny vessels. Vericiguat works by helping blood vessels relax and widen, which may improve blood flow and reduce chest pain in patients with this condition.

What is already known about the treatment

Vericiguat – Vericiguat is administered orally in the form of tablets and is currently being studied for its effects on vasospastic angina, a condition characterized by spasms in the heart's blood vessels. This medication is in the clinical trial phase, with research focusing on its ability to improve microvascular function in patients with this type of angina. Vericiguat works by enhancing the signaling pathway of a molecule called cyclic guanosine monophosphate (cGMP), which helps relax blood vessels and improve blood flow. It is classified as a soluble guanylate cyclase (sGC) stimulator, a type of drug that targets specific pathways to help manage heart-related conditions.

Investigated diseases

Vasospastic Angina – Vasospastic angina, also known as Prinzmetal's angina, is a condition characterized by sudden spasms in the coronary arteries, which can temporarily reduce blood flow to the heart. These spasms can occur at rest and are often accompanied by chest pain. The condition is caused by a temporary narrowing of the coronary arteries due to the contraction of the muscular wall of the arteries. Unlike typical angina, which is usually triggered by physical exertion or stress, vasospastic angina can occur without any apparent trigger. The spasms can last from a few minutes to several minutes and may occur in cycles. Over time, repeated episodes can lead to changes in the heart's blood vessels, potentially affecting heart function.