Not recruitingRare disease

Study on Sotatercept for Treating Pulmonary Hypertension in Adults with Heart Failure

Fast replyInvestigational

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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 Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH), which occurs due to Heart Failure with Preserved Ejection Fraction (HFpEF). This condition affects the blood vessels in the lungs and the heart's ability to pump blood efficiently. The study will evaluate a treatment using a medication called sotatercept, which is administered as a solution for injection. Sotatercept is being compared to a placebo to understand its effects on this type of pulmonary hypertension.

The purpose of the study is to assess how effective and safe sotatercept is for people with Cpc-PH due to HFpEF. Participants in the study will receive either sotatercept or a placebo. The study will monitor changes in the participants' health over time, focusing on how well their blood vessels function and their ability to walk a certain distance. The study will also keep track of any side effects or health changes that occur during the treatment period.

Participants will be involved in the study for a period of time, during which they will receive regular check-ups and assessments to monitor their condition and response to the treatment. The study aims to provide valuable information on whether sotatercept can be a beneficial treatment option for individuals with this specific type of pulmonary hypertension.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current medications.
A clinical diagnosis of heart failure with preserved ejection fraction and pulmonary hypertension is required. Specific measurements from a right heart catheterization are necessary.
Step 2
Randomization
Participants are randomly assigned to receive either the study drug, sotatercept, or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.
Step 3
Treatment administration
The study drug, sotatercept, is administered as a solution for injection under the skin (subcutaneous).
The dosage and frequency of administration are determined by the study protocol and are followed throughout the trial.
Step 4
Monitoring and follow-up
Regular visits are scheduled to monitor health status and response to treatment. This includes measuring changes in pulmonary vascular resistance and six-minute walk distance.
Safety and tolerability are assessed through various tests and observations.
Step 5
End of treatment evaluation
At the end of the treatment period, a final evaluation is conducted to assess the overall effects of the treatment.
Participants may be asked to continue follow-up visits to monitor long-term outcomes.

Who can join the trial?

11 criteria

Age between 18 and 85 years.
Agree not to participate in any other trials of experimental drugs or devices while in this study.
Ability to understand and provide written consent to participate.
Have a clinical diagnosis of **HFpEF**: This means the heart's left side pumps normally, but the heart is stiff and doesn't fill properly. The left ventricular ejection fraction should be 50% or higher, with no history of it being below 45% in more than two stable measurements.
Show evidence of **Cpc-PH**: This is a type of high blood pressure in the lungs due to heart issues. It must be confirmed by a test called **RHC** (right heart catheterization) within 28 days before starting the study, showing specific pressure measurements in the lungs.
Belong to New York Heart Association **FC II or III**: This is a classification of heart failure based on symptoms and physical activity limitations.
Be able to walk at least 100 meters in six minutes, measured twice during screening, with both results being similar.
Be on stable medication for heart failure or any other condition for at least 30 days before the first visit. Diuretics and anticoagulants are exceptions but should not be started or stopped within 30 days of the first visit, and any dose changes should not occur within 7 days of the first visit.
Women who can have children must have two negative pregnancy tests during screening, agree to ongoing pregnancy testing, use effective birth control, and not breastfeed or donate eggs during the study and for 16 weeks after the last dose.
Men must agree to use condoms during sexual contact with a pregnant woman or a woman who can have children, and not donate blood or sperm during the study and for 16 weeks after the last dose.
Ability to follow the study visit schedule and comply with all study requirements.

Who cannot join the trial?

10 criteria

Patients with other types of heart or lung diseases that are not related to the specific condition being studied.
Patients who have had a recent heart attack or stroke.
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 have had a major surgery within the last 3 months.
Patients with uncontrolled high blood pressure.
Patients with a known allergy to the study medication.
Patients who are unable to walk a certain distance, which is part of the study's assessment.

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Verified sites

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Azienda Ospedaliera Papa Giovanni XXIII
Verified
Bergamo, Italy
Thoraxklinik Heidelberg gGmbH
Responsive
Heidelberg, Germany
Universita Degli Studi Di Roma La Sapienza
Responsive
Rome, Italy

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Investigated drugs

Sotatercept is a medication being studied for its potential to treat a specific type of pulmonary hypertension, which is a condition affecting the blood vessels in the lungs. This trial is focused on patients who have pulmonary hypertension due to heart failure with preserved ejection fraction. The study aims to see if sotatercept can improve the function of these blood vessels and help patients walk longer distances, which is a measure of their physical capacity. The safety and tolerability of sotatercept are also being evaluated to ensure it is safe for patients to use.

Sotatercept

What is already known about the treatment

Sotatercept – Sotatercept is administered via injection and is currently being studied in clinical trials for its potential benefits in treating combined postcapillary and precapillary pulmonary hypertension due to heart failure with preserved ejection fraction. It is not yet widely used in medical practice, as it is still under investigation. The main therapeutic indication for sotatercept is to improve pulmonary vascular resistance and exercise capacity in affected individuals. At the molecular level, sotatercept works by binding to and inhibiting specific proteins involved in the regulation of blood vessel growth and function, which may help reduce blood pressure in the lungs. It is classified pharmacologically as a receptor fusion protein.

Investigated diseases

Combined Postcapillary and Precapillary Pulmonary Hypertension due to Heart Failure with Preserved Ejection Fraction – This condition involves high blood pressure in the lungs' blood vessels, which occurs due to heart failure where the heart's pumping ability is normal. It combines two types of pulmonary hypertension: postcapillary, related to issues in the left side of the heart, and precapillary, involving the blood vessels in the lungs themselves. Over time, this can lead to increased resistance in the pulmonary arteries, making it harder for the heart to pump blood through the lungs. This condition can cause symptoms like shortness of breath, fatigue, and reduced ability to exercise. It is considered a rare disease and can significantly impact daily activities.