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Long-term treatment with sotatercept for pulmonary hypertension

A Phase 2, Multicenter, Double-blind, Extension Study to Evaluate the Effects of Sotatercept for the Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) Due to Heart Failure With Preserved Ejection Fraction (HFpEF)

Phase 2 Interventional Merck Sharp & Dohme LLC · NCT06814145

This study is testing if long-term use of sotatercept is safe and well-tolerated for people with a specific type of pulmonary hypertension related to heart failure.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment130 (estimated)
Ages18 Years and up
SexAll
SponsorMerck Sharp & Dohme LLC Industry-sponsored
Locations56 sites (Phoenix, Arizona and 55 other locations)
Trial IDNCT06814145 on ClinicalTrials.gov

What this trial studies

This extension study investigates the long-term safety and tolerability of sotatercept in individuals with combined postcapillary and precapillary pulmonary hypertension (Cpc-PH) caused by heart failure with preserved ejection fraction (HFpEF). Participants who previously completed a related study will continue to receive sotatercept while researchers monitor their health over an extended period. The study aims to gather more data on the effects of this treatment in a specific patient population.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals who have completed a prior study on sotatercept without discontinuation and have Cpc-PH caused by HFpEF.

Not a fit: Patients with other forms of pulmonary hypertension or those who have had significant interruptions in study interventions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new long-term treatment option for patients suffering from Cpc-PH due to HFpEF.

How similar studies have performed: Other studies on sotatercept have shown promise, indicating potential for success in this extension study.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

\- Completed MK-7962-007 (CADENCE) (Visit 9 and end of treatment \[EOT\] visit) without discontinuing study intervention and is able to safely enroll into MK-7962-007 (HARMONIZE)

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* Has a diagnosis of pulmonary hypertension (PH) in world health organization (WHO) Group 1, WHO Group 3, WHO Group 4, or WHO Group 5
* Has had a study intervention interruption
* Is pregnant or breastfeeding
* Has chronic liver disease with severe hepatic impairment and/or cirrhosis (eg, hepatic encephalopathy)
* Anticipation of more than 1 valve replacement or repair (mechanical or biomechanical) and/or have undergone more than 1 valve replacement or repair
* Has severe tricuspid regurgitation due to primary valvular disease (eg, from endocarditis, carcinoid, or mechanical destruction)
* Anticipated or undergone heart transplant or ventricular assist device implantation
* Has had prior exposure to luspatercept

Where this trial is running

Phoenix, Arizona and 55 other locations

+6 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hypertension, Pulmonary
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.