RecruitingRare disease

Study on Sotatercept for Improving Heart Function in Patients with Pulmonary Arterial Hypertension

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 treatment for Pulmonary Arterial Hypertension (PAH), a condition where the blood pressure in the arteries of the lungs is higher than normal. The treatment being tested is called Sotatercept, also known by its code name ACE-011. Sotatercept is administered as a powder that is mixed into a solution and given through an injection under the skin.

The purpose of this study is to evaluate how Sotatercept affects the function of the right side of the heart in patients with PAH. The study will observe changes in how the heart works and how it interacts with the blood vessels in the lungs. Participants will receive Sotatercept over a period of 24 weeks, and various heart functions will be monitored to assess the treatment's impact.

This study is designed to provide insights into how Sotatercept can help manage PAH by improving heart function. The trial is open-label, meaning both the researchers and participants know what treatment is being administered. The information gathered from this study aims to enhance understanding of PAH treatment and potentially improve outcomes for those affected by this condition.

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, you will be required to provide signed informed consent, confirming your understanding and agreement to participate in the trial.
Eligibility criteria include being an adult between 18-70 years of age with a diagnosis of idiopathic or hereditary pulmonary arterial hypertension, and having stable background therapy for at least 3 months before the screening period.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes a hemodynamic diagnosis of pulmonary arterial hypertension confirmed by right heart catheterization, showing a mean pulmonary artery pressure greater than 20 mmHg, and other specific measurements.
Your NTproBNP levels will also be checked to ensure they are greater than 300 ng/L.
Step 3
Medication administration
You will receive the medication sotatercept, which is administered as a subcutaneous injection. This means the medication is injected under the skin.
The dosage is 60 mg of Winrevair, a powder that is mixed into a solution for injection.
Step 4
Treatment period
The treatment with sotatercept will continue for a period of 24 weeks. During this time, you will receive regular injections as per the study protocol.
You will be monitored for any changes in your condition, specifically focusing on the effects of the medication on your heart and pulmonary artery function.
Step 5
Follow-up assessments
Throughout the trial, follow-up assessments will be conducted to measure changes in your heart's function and structure. This includes evaluating the power per beat and the right ventricular pulmonary artery coupling index.
Secondary assessments will also be conducted to measure various heart volumes, ejection fractions, and other related parameters using imaging techniques.
Step 6
Completion of the trial
At the end of the 24-week period, a final assessment will be conducted to evaluate the overall effects of the medication on your condition.
The results will contribute to understanding the impact of sotatercept on right ventricular function in pulmonary arterial hypertension.

Who can join the trial?

9 criteria

Adult patients between 18-70 years of age with a diagnosis of idiopathic (unknown cause) or hereditary (inherited) pulmonary arterial hypertension.
Able to provide signed informed consent, meaning you understand the study and agree to participate.
WHO functional class between II and IV, which describes the severity of your symptoms and how they affect your daily activities.
Hemodynamic diagnosis of pulmonary arterial hypertension confirmed by a test called right heart catheterization at screening, showing:
- mPAP (mean pulmonary arterial pressure) greater than 20 mmHg.
- PCWP (pulmonary capillary wedge pressure) or LVEDP (left ventricular end diastolic pressure) less than or equal to 15 mmHg.
- PVR (pulmonary vascular resistance) greater than or equal to 4 Wood units (320 dyn.sec.cm-5).
- Stable background therapy for at least 3 months before the screening period, meaning your current treatment has not changed recently.
- NTproBNP level greater than 300 ng/L, which is a blood test that helps assess heart strain.
- Pulmonary arterial hypertension caused by either idiopathic or heritable factors.

Who cannot join the trial?

10 criteria

Patients with any other serious medical condition that might interfere with the study.
Patients who have had a heart attack or stroke in the past 6 months.
Patients with uncontrolled high blood pressure.
Patients with severe liver disease.
Patients with severe kidney disease.
Patients who are pregnant or breastfeeding.
Patients who are currently participating in another clinical trial.
Patients who have had an organ transplant.
Patients with a history of drug or alcohol abuse in the past year.
Patients with a known allergy to the study medication.

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Amsterdam UMC
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Amsterdam, The Netherlands

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Investigated drugs

Sotatercept is a medication being studied for its potential to help people with pulmonary arterial hypertension, a condition where the blood pressure in the lungs is too high. This medication works by targeting specific proteins in the body that are involved in the growth and repair of blood vessels. In this trial, researchers are looking at how sotatercept can improve the function of the right side of the heart, which can be affected by this type of high blood pressure. The goal is to see if sotatercept can help the heart work better and improve the connection between the heart and the blood vessels in the lungs.

Sotatercept

What is already known about the treatment

Sotatercept – Sotatercept is administered through an injection, typically under the skin. It is currently being studied in clinical trials for its effects on heart function in people with pulmonary arterial hypertension, a condition where high blood pressure affects the arteries in the lungs and heart. The main goal of using sotatercept is to improve how the right side of the heart works and how it connects with the blood vessels in the lungs. At the molecular level, sotatercept works by blocking certain proteins that can cause blood vessels to narrow, helping to reduce blood pressure in the lungs. It is classified as a type of medication that targets specific pathways involved in blood vessel function.

Investigated diseases

Pulmonary arterial hypertension – Pulmonary arterial hypertension is a condition characterized by high blood pressure in the arteries that supply the lungs. This increased pressure makes it difficult for the heart to pump blood through the lungs, leading to strain on the right side of the heart. Over time, the heart may become enlarged and weakened due to the increased workload. Symptoms often include shortness of breath, fatigue, dizziness, and swelling in the ankles or legs. As the disease progresses, these symptoms may become more severe and can limit physical activity. The condition is considered a rare disease and requires careful management to monitor its progression.