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Sotatercept for Pulmonary Hypertension (CADENCE Trial)

Phase 2
Recruiting
Research Sponsored by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must be aged between 18 to 85 years
Ability to understand and provide documented consent for participation
Must not have
Body mass index ≥50 kg/m2, untreated or severe obstructive sleep apnea, and any non-cardiopulmonary conditions limiting the ability to perform 6MWT
Diagnosis of PH in WHO Group 1, 3, 4, or 5
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 24

Summary

This trial tests sotatercept, a medication aimed at improving heart and lung function in adults with a specific type of heart failure. It works by reducing resistance in lung blood vessels, helping the heart pump blood more easily.

Who is the study for?
Adults aged 18-85 with Cpc-PH due to HFpEF, stable on heart failure medications for at least 30 days, and able to perform a six-minute walk test. Participants must not have severe lung disease, liver disease, recent major surgery or other significant health issues that could interfere with the study.
What is being tested?
The trial is testing Sotatercept's effectiveness in improving pulmonary vascular resistance and exercise capacity compared to placebo in patients with high blood pressure-related pulmonary hypertension caused by heart failure with preserved ejection fraction.
What are the potential side effects?
Potential side effects of Sotatercept may include headache, respiratory tract infection, joint pain, nausea or vomiting. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 85 years old.
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I can understand and agree to participate in the study.
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I agree to use contraception and not donate blood or sperm.
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My heart pumps well, with an ejection fraction of 50% or higher, and it has never been below 45%.
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My heart and lung tests show specific pressures and I can walk at least 100 meters.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a BMI of 50 or more, severe sleep apnea, and conditions that prevent me from walking.
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I have been diagnosed with pulmonary hypertension.
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I have a serious lung condition like COPD or interstitial lung disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 24
Secondary study objectives
Change From Baseline in Isovolumic Relaxation Time (IVRT) at Week 24
Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Week 24
Change From Baseline in Mean Pulmonary Arterial Pressure (mPAP) at Week 24
+10 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Sotatercept 0.3 mg/kg, escalating to 0.7 mg.kgExperimental Treatment1 Intervention
Sotatercept SC at a starting dose level of 0.3 mg/kg for 3 dosing visits (Q3W), then escalating to 0.7 mg/kg SC on the fourth dosing visit and Q3W for the remainder of the 24-week treatment Period.
Group II: Sotatercept 0.3 mg/kgExperimental Treatment1 Intervention
Participants will receive sotatercept SC at a dose level of 0.3 mg/kg Q3W for 24 weeks in the placebo-controlled treatment period.
Group III: PlaceboPlacebo Group1 Intervention
Delivered subcutaneously (SC) every 3 weeks (Q3W) for 24 weeks in the placebo-controlled treatment period.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Pulmonary Hypertension (PH) primarily focus on pulmonary vasodilation and reducing vascular resistance. Phosphodiesterase type 5 (PDE5) inhibitors, such as sildenafil, increase cyclic guanosine monophosphate (cGMP) levels, leading to vasodilation and improved blood flow. Endothelin receptor antagonists (ERAs), like bosentan, block endothelin-1, a potent vasoconstrictor, thereby reducing vascular resistance. Prostacyclin analogs, such as treprostinil, mimic the effects of prostacyclin, promoting vasodilation and inhibiting platelet aggregation. These treatments are crucial for PH patients as they alleviate symptoms and improve exercise capacity. Sotatercept, an investigational drug, differs by targeting the underlying mechanisms of pulmonary vascular remodeling, potentially offering a novel approach to treating PH by addressing the root cause of vascular changes.
Management of Pulmonary Arterial Hypertension.

Find a Location

Who is running the clinical trial?

Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USALead Sponsor
32 Previous Clinical Trials
4,117 Total Patients Enrolled
Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)Lead Sponsor
32 Previous Clinical Trials
4,117 Total Patients Enrolled
Acceleron Pharma Inc.Lead Sponsor
26 Previous Clinical Trials
2,895 Total Patients Enrolled

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT04945460 — Phase 2
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT04945460 — Phase 2
Pulmonary Hypertension Research Study Groups: Sotatercept 0.3 mg/kg, escalating to 0.7 mg.kg, Sotatercept 0.3 mg/kg, Placebo
Pulmonary Hypertension Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT04945460 — Phase 2
Pulmonary Hypertension Patient Testimony for trial: Trial Name: NCT04945460 — Phase 2
~33 spots leftby Oct 2025