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Study on the Effects of Riociguat for Patients with Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension

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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 the medication Riociguat on two specific conditions: Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension. These are serious conditions that affect the blood vessels in the lungs and can lead to increased pressure in the arteries, making it difficult for the heart to pump blood through the lungs. The purpose of the study is to investigate how Riociguat affects the size and function of the right side of the heart, specifically the right ventricle and right atrium, which are important for pumping blood to the lungs.

Participants in the study will receive Riociguat in the form of film-coated tablets taken orally. The study will observe changes in the heart's right ventricle and atrium over a period of 24 weeks, with key assessments at the start, 12 weeks, and 24 weeks. The study will also compare these changes to see how the heart's function improves or changes with the treatment. Some participants may receive a placebo, which is a tablet that looks like the medication but does not contain the active substance.

Throughout the study, various tests will be conducted to monitor heart function and overall health. These tests include echocardiography, which uses sound waves to create images of the heart, and other assessments to measure blood pressure and heart rate. The study aims to provide valuable information on the effectiveness of Riociguat in treating these conditions and improving heart function. Participants will be closely monitored to ensure their safety and 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 patient will begin treatment with riociguat, a medication used to treat certain types of high blood pressure in the lungs.
The medication is administered in the form of a film-coated tablet and is taken orally.
Step 2
Initial assessment
An initial assessment will be conducted to establish baseline measurements of the heart's right ventricle and atrium using echocardiography.
This assessment will help in comparing changes over the course of the study.
Step 3
Medication administration
The patient will take riociguat as prescribed, with the dosage and frequency determined by the study protocol.
The treatment will continue for a period of 24 weeks, with regular monitoring and assessments.
Step 4
12-week assessment
At 12 weeks, an assessment will be conducted to measure changes in the right ventricle and atrium size and function.
Additional parameters such as blood pressure, heart rate, and exercise capacity may also be evaluated.
Step 5
24-week assessment
At 24 weeks, a final assessment will be conducted to evaluate the primary endpoint, which is the change in the right ventricle and atrium area from the baseline.
Secondary endpoints, including various heart and lung function parameters, will also be assessed.
Step 6
Completion of study
Upon completion of the 24-week treatment period, the patient's participation in the study will conclude.
Final evaluations will be conducted to assess the overall effects of the treatment.

Who can join the trial?

9 criteria

Patients must have **Pulmonary Arterial Hypertension (PAH)**, which is high blood pressure in the lungs, with certain measurements: mean pulmonary artery pressure (mPAP) greater than 20 mmHg and pulmonary vascular resistance (PVR) of at least 2 Wood Units (WU), and pulmonary arterial wedge pressure (PAWP) of 15 mmHg or less.
Patients can also have **Chronic Thromboembolic Pulmonary Hypertension (CTEPH)**, which is a type of high blood pressure in the lungs due to blood clots, with specific conditions: inoperable cases measured at least 3 months after starting full anticoagulation, or cases where high blood pressure persists or returns after surgery, with the same measurements as above.
Patients can be either new to treatment for PAH or have been treated with certain medications like an endothelin receptor antagonist, prostacyclin, or prostacyclin analogue.
Patients who have been treated with a **phosphodiesterase type 5 inhibitor (PDE-5)**, a type of medication, must be stable on this treatment for at least two months before the first visit. "Stable" means no changes in the type or dose of the medication.
Patients must stop taking PDE-5 inhibitors (sildenafil 24 hours, tadalafil 48 hours) before switching to the study medication, **riociguat**.
The switch to riociguat should be due to medical reasons, especially if the patient's condition remains at an intermediate risk level despite previous treatment.
Right heart catheterization (RHC) results, a test to measure pressure in the heart and lungs, must be no older than 6 months at the time of screening.
Both male and female patients are eligible to participate.
The study includes patients from certain age groups, but specific age ranges are not detailed here.

Who cannot join the trial?

8 criteria

Patients who are pregnant or breastfeeding cannot participate.
Individuals with severe liver disease are excluded. The liver is an organ that helps process food and remove toxins from the body.
Patients with severe kidney disease are not eligible. The kidneys help filter waste from the blood.
People who have had a heart attack in the last 6 months cannot join. A heart attack happens when blood flow to the heart is blocked.
Individuals with uncontrolled high blood pressure are excluded. High blood pressure means the force of blood against the artery walls is too high.
Patients with a history of severe allergic reactions to the study medication cannot participate. An allergic reaction is when the body reacts strongly to a substance.
People who are currently participating in another clinical trial are not eligible.
Individuals with any other medical condition that the study doctors think would make it unsafe to participate are excluded.

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Thoraxklinik Heidelberg gGmbH
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Heidelberg, Germany

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Investigated drugs

Riociguat is a medication used in this clinical trial to study its effects on the heart's right ventricle and right atrium in patients with Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension. The trial aims to observe changes in the size and function of these heart areas over a period of 24 weeks while patients are on this therapy.

Riociguat

What is already known about the treatment

Riociguat – Riociguat is administered orally in tablet form and is currently being studied for its effects on right ventricular size and function in patients with Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension. It is an approved medication in the treatment of these conditions and is well-documented in medical literature. The main therapeutic indication for Riociguat is to improve exercise capacity and delay clinical worsening in these types of hypertension. At the molecular level, Riociguat works by stimulating the enzyme soluble guanylate cyclase, which leads to relaxation and widening of blood vessels, reducing blood pressure in the lungs. It is classified pharmacologically as a soluble guanylate cyclase stimulator.

Investigated diseases

Pulmonary Arterial Hypertension
This is a condition characterized by high blood pressure in the arteries that supply the lungs. It occurs when the small arteries in the lungs become narrowed or blocked, making it harder for blood to flow through them. As a result, the heart has to work harder to pump blood through the lungs, which can lead to heart enlargement and eventually heart failure. Symptoms often include shortness of breath, fatigue, dizziness, and swelling in the ankles or legs. Over time, the increased pressure can cause damage to the heart and lungs. The progression of the disease can vary, with some individuals experiencing a gradual worsening of symptoms.
Chronic Thromboembolic Pulmonary Hypertension
This disease is a form of pulmonary hypertension caused by old blood clots in the lungs that have not been fully resolved. These clots can obstruct the pulmonary arteries, leading to increased pressure and strain on the heart. Symptoms may include shortness of breath, fatigue, chest pain, and fainting spells. The condition can develop slowly over time, often following an acute pulmonary embolism. As the disease progresses, it can lead to right heart failure due to the increased workload on the heart. The severity and progression of symptoms can vary among individuals.