Study on Sotatercept for Treating Pulmonary Hypertension in Patients with Heart Failure with Preserved Ejection Fraction

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for Pulmonary Hypertension, a condition where there is high blood pressure in the blood vessels that supply the lungs. The specific type of pulmonary hypertension being studied is related to heart failure with preserved ejection fraction, which means the heart pumps normally but is too stiff to fill properly. The treatment being tested is called sotatercept, also known by its code name MK-7962. Sotatercept is a solution for injection and is designed to help manage this condition.

The purpose of this study is to evaluate the long-term safety and tolerability of sotatercept over a period of up to 42 months. Participants in the study will receive sotatercept through subcutaneous injections, which means the medication is injected under the skin. The study will monitor participants for any adverse events, which are unwanted effects that may occur during the treatment. Additionally, the study will assess changes in participants’ ability to walk a certain distance in six minutes, as well as changes in their heart function and blood pressure in the lungs over time.

This study is an extension of previous research and aims to provide more information on how well sotatercept works and how safe it is for people with pulmonary hypertension. Participants will be closely monitored throughout the study to ensure their safety and to gather data on the effectiveness of the treatment. The study is expected to continue until 2029, allowing researchers to collect comprehensive data on the long-term effects of sotatercept.

1 joining the study

Upon joining the study, you will be informed about the purpose and procedures involved. This study aims to evaluate the long-term safety and tolerability of sotatercept for the treatment of pulmonary hypertension due to heart failure with preserved ejection fraction.

2 initial assessment

An initial assessment will be conducted to ensure you meet the criteria for participation. This includes confirming that you have completed the previous study, MK-7962-007 (CADENCE), without discontinuing the study intervention.

3 treatment administration

You will receive sotatercept as a solution for injection administered subcutaneously (under the skin). The frequency and dosage will be determined by the study protocol and your healthcare provider.

4 regular follow-up visits

Regular follow-up visits will be scheduled to monitor your health and the effects of the treatment. These visits will include assessments of your pulmonary vascular resistance and your ability to walk for six minutes, among other evaluations.

5 monitoring for adverse events

Throughout the study, you will be monitored for any adverse events, which are any unwanted effects that may occur during the treatment. If any adverse events occur, they will be documented, and appropriate measures will be taken.

6 long-term evaluation

The study will continue for up to 42 months, during which your response to the treatment will be evaluated at various intervals, including weeks 48, 126, and 174. This will involve measuring changes in your condition from the start of the study.

7 completion of the study

Upon completion of the study, a final assessment will be conducted to evaluate the overall effects of the treatment and to ensure your well-being.

Who Can Join the Study?

  • You must have completed the previous study called MK-7962-007 (CADENCE) without stopping the study treatment early and be able to safely join the new study called MK-7962-007 (HARMONIZE).
  • You must have a condition called Pulmonary Hypertension.
  • Both men and women can participate.
  • Participants must be within the age range specified by the study, which includes adults.

Who Cannot Join the Study?

  • Patients with any other serious medical condition that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial within the last 30 days.
  • Patients with a history of allergic reactions to the study medication.
  • Patients with uncontrolled high blood pressure.
  • Patients with severe liver or kidney disease.
  • Patients with a history of drug or alcohol abuse within the past year.
  • Patients who are unable to comply with the study procedures.

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 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
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Hospital Costa del Sol Marbella Spain
Krankenhaus Neuwittelsbach Munich Germany
Cnpthn Hakgxcyeqpi Rjhvtdaf Dsnzclfgoxiefl Angers France
Uuwlojhtwz Hhruxvur Chmzofj Cologne Germany
Atrujxf Ovvxbhasfvb Patx Gjdyebst Xzhqv Bergamo Italy
Uvygwmplle Dkaxk Svqto Dd Rvvu Lj Swmdgdeq Rome Italy
Kznqdorua Sotrpbx Slqwcgodlgaunjo ib Jeiz Plwvu Id Cracow Poland
Cch Kyscwbt Bglhnbj Le Kremlin-Bicetre France

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
10.03.2025
France France
Not recruiting
10.03.2025
Germany Germany
Not recruiting
10.03.2025
Italy Italy
Not recruiting
10.03.2025
Poland Poland
Not recruiting
10.03.2025
Spain Spain
Not recruiting
10.03.2025
Sweden Sweden
Not recruiting
10.03.2025

Trial locations

Investigated drugs:

Sotatercept is a medication being studied for its potential to help people with a specific type of high blood pressure in the lungs, known as pulmonary hypertension, which occurs due to heart failure with preserved ejection fraction. This condition involves both the blood vessels in the lungs and the heart. Sotatercept works by targeting certain proteins in the body that are involved in the development of this type of high blood pressure. The goal of using sotatercept in this study is to see if it can safely and effectively reduce the pressure in the lungs and improve heart function over a long period of time.

Pulmonary Hypertension – Pulmonary Hypertension is a condition characterized by high blood pressure in the arteries of the lungs. This increased pressure makes it difficult for the heart to pump blood through the lungs, leading to symptoms such as shortness of breath, fatigue, and dizziness. Over time, the heart may become enlarged and weakened due to the increased workload. The disease progresses as the blood vessels in the lungs become more narrowed or blocked, further increasing the pressure. As the condition advances, it can lead to complications such as right-sided heart failure. Pulmonary Hypertension can be caused by various underlying conditions, including heart and lung diseases.

Trial ID:
2024-515773-99-00
Protocol code:
MK-7962-023
Trial Phase:
Therapeutic exploratory (Phase II)

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