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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Hospital Universitario 12 De Octubre Madrid Spain
Wojewodzki Specjalistyczny Szpital Im Dr Wl Bieganskiego Lodz Poland
Wojewodzki Szpital Specjalistyczny Im. Stefana Kardynala Wyszynskiego Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Lublinie Lublin Poland
Uniwersytecki Szpital Kliniczny W Bialymstoku Bialystok Poland
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Hospital Clinic De Barcelona Barcelona Spain
Centre Hospitalier Universitaire De Montpellier Montpellier France
Justus-Liebig-Universitaet Giessen Giessen Germany
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Nice Nice France
Kerckhoff-Klinik GmbH Bad Nauheim Germany
Thoraxklinik Heidelberg gGmbH Heidelberg Germany
Hopital Beaujon Clichy France
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Hospital Costa del Sol Marbella Spain
Krankenhaus Neuwittelsbach Munich Germany
Uiqpmpduoi Haknvjvh Cenlpxd Cologne Germany
Ajsqykw Ufkog Suitttshf Lejamb Dg Bacmqdl Bologna Italy
Azbcfpr Oisnslfcmfj Pqli Gvawpait Xellz Bergamo Italy
Uextlvpqcv Dhagu Svfuz Dq Ryqe La Ssdxppec Rome Italy
Cdeniz Hqhvfvrmjjt Rfkvzpyc Dkyffmhsficylp Angers France
Kgaatnunh Spjbyvt Sfhfrcynqvzqjop it Jdkj Pzmyn Ib Cracow Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
30.11.2021
France France
Not recruiting
30.11.2021
Germany Germany
Not recruiting
30.11.2021
Italy Italy
Not recruiting
30.11.2021
Poland Poland
Not recruiting
30.11.2021
Spain Spain
Not recruiting
30.11.2021
Sweden Sweden
Not recruiting
30.11.2021

Trial locations

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.

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.

Trial ID:
2023-509141-12-00
Protocol code:
A011-16
NCT ID:
NCT04945460
Trial Phase:
Therapeutic exploratory (Phase II)

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