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Study on the Effects of Riociguat in Patients with Pulmonary Hypertension Due to Left Heart Failure

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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 condition known as pulmonary hypertension, which is a type of high blood pressure that affects the arteries in the lungs and the right side of the heart. Specifically, the study is looking at pulmonary hypertension that is associated with a condition called left ventricular systolic dysfunction, where the left side of the heart does not pump blood effectively. The treatment being tested in this study is a medication called Riociguat, which is taken as a film-coated tablet. Riociguat is being evaluated for its effects on the heart and blood vessels in patients with this type of pulmonary hypertension.

The purpose of the study is to assess how Riociguat affects the heart and blood flow in patients with pulmonary hypertension linked to left heart failure. Participants in the study will be randomly assigned to receive either Riociguat or a placebo. The study will be conducted over a period of time, during which participants will take the medication and undergo various tests to monitor their heart function and overall health. These tests will include measurements of blood pressure in the lungs and assessments of heart performance.

Throughout the study, the safety of Riociguat will be closely monitored, and blood samples will be collected to understand how the drug is processed in the body. The study aims to provide valuable information on the potential benefits and safety of Riociguat for patients with pulmonary hypertension associated with left ventricular systolic dysfunction. Participants will be followed up regularly to track any changes in their condition and to ensure their well-being during the trial.

The research process

The trial runs in 6 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, the participant is required to provide written informed consent, confirming understanding and willingness to participate in the trial.
Eligibility is confirmed based on criteria such as age, medical condition, and previous treatments.
Step 2
Baseline assessment
Initial assessments are conducted to establish baseline measurements. These include tests to measure heart function and blood pressure in the lungs.
A right heart catheterization (RHC) is performed to measure pressures in the heart and lungs.
Step 3
Medication administration
Participants are randomly assigned to receive either Riociguat Bayer or a placebo. The medication is administered orally in the form of a film-coated tablet.
The dosage and frequency of administration are determined by the study protocol and are monitored throughout the trial.
Step 4
Ongoing assessments
Regular assessments are conducted to monitor the participant's health and response to the medication. These include measuring changes in heart and lung function.
Participants undergo tests such as echocardiography and blood tests to evaluate the effects of the treatment.
Step 5
Final assessment
At the end of the study period, a final assessment is conducted to evaluate the overall impact of the treatment.
The primary focus is on changes in pulmonary artery pressure and other key health indicators.
Step 6
Completion of the study
Upon completion of the study, participants may receive information about the results and any potential next steps in their treatment plan.
The study aims to conclude by the estimated end date of December 31, 2025.

Who can join the trial?

10 criteria

Participants must be between 18 and 80 years old at the time they agree to join the study.
Both men and women with **symptomatic pulmonary hypertension** linked to **left ventricular systolic dysfunction** (PH-sLVD) can join. This condition is due to **ischemic heart disease** or **dilated cardiomyopathy** (DCM). People waiting for a heart transplant can also participate. Other types of pulmonary hypertension must be ruled out.
PH-sLVD is defined as having a **left ventricular ejection fraction (LVEF)** of 40% or less, which is determined by tests like echocardiography or heart catheter exams. Also, the **mean pulmonary artery pressure (PAPmean)** should be 25 mmHg or higher at rest, measured by a right heart catheter (RHC).
Participants must have been treated with the best possible therapy for **chronic heart failure (CHF)** according to guidelines. This includes medications like ACE inhibitors, ARBs, beta blockers, and MR antagonists. The medication doses must have been stable for more than 30 days before joining the study. Diuretic therapy should be stable for at least 1 week before the baseline RHC.
RHC results for confirming PH should not be older than 1 week at the first visit. The test must be done at the participating center under standard conditions.
Results from a left heart catheter test should be available before joining the study to determine if the heart condition is due to ischemic heart disease or DCM.
A negative **stress test** must have been done less than 1 year before joining the study to rule out obvious or hidden heart issues. This can include tests like stress ECG, stress echocardiography, or stress scintigraphy.
Women can participate if they are not able to have children, which includes being postmenopausal, having had certain surgeries, or if they are of childbearing potential, they must have a negative pregnancy test and use effective birth control methods during the study.
Participants must be able to understand and follow instructions and be willing to participate for the entire study period.
Participants must provide written informed consent to join the study.

Who cannot join the trial?

5 criteria

Patients who do not have symptoms of pulmonary hypertension linked to left ventricular systolic dysfunction. Pulmonary hypertension is high blood pressure in the blood vessels of the lungs, and left ventricular systolic dysfunction means the left side of the heart is not pumping well.
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial groups.
Patients who are not male or female, as both genders are included in the study.
Patients who are not considered part of a vulnerable population, which means groups that might need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Fondazione IRCCS Policlinico San Matteo
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Pavia, Italy
University Hospital Cologne
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Cologne, Germany
Vseobecna Fakultni Nemocnice V Praze
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Prague, Czechia

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Investigated drugs

Riociguat is a medication being studied for its effects on blood flow in patients with pulmonary hypertension, which is high blood pressure in the lungs, associated with left ventricular systolic dysfunction. This medication is being tested to see how it affects the heart and blood vessels, and to ensure it is safe for patients with this condition.

Riociguat

What is already known about the treatment

Riociguat – Riociguat is administered orally in tablet form. It is currently being studied in clinical trials for its effects on pulmonary hypertension associated with left ventricular systolic dysfunction. The main therapeutic indication for Riociguat is to improve blood flow and reduce blood pressure in the lungs. At the molecular level, Riociguat works by stimulating an enzyme called soluble guanylate cyclase, which helps relax and widen blood vessels. It is classified as a vasodilator, specifically targeting the pulmonary arteries.

Investigated diseases

Pulmonary Hypertension Associated with Left Ventricular Systolic Dysfunction (PH-sLVD) – This condition occurs when there is high blood pressure in the lungs' arteries, linked to the heart's left ventricle not pumping effectively. The heart's left ventricle is responsible for pumping oxygen-rich blood to the body, and when it weakens, it can lead to increased pressure in the pulmonary arteries. Over time, this increased pressure can cause the right side of the heart to work harder, potentially leading to heart enlargement and further complications. Symptoms often include shortness of breath, fatigue, and swelling in the legs and ankles. As the condition progresses, it can significantly impact a person's ability to perform physical activities. Monitoring and managing the condition is crucial to prevent further heart strain and maintain quality of life.