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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from week 24 to week 48 of the extension period
Awards & highlights

CADENCE Trial Summary

This trial will enroll approximately 300 participants who will be randomized 1:1 to receive either sotatercept or placebo.

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.Check my eligibility
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.See study design
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.

CADENCE 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.

CADENCE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from week 24 to week 48 of the extension period
This trial's timeline: 3 weeks for screening, Varies for treatment, and from week 24 to week 48 of the extension period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 24
Secondary outcome measures
Change From Baseline in Dyspnea Score As Assessed by Borg Category Ratio 10 Scale® at Week 24
Change From Baseline in E/e' (Early Mitral Inflow Velocity E and Mitral Annular Early Diastolic Velocity e') Ratio at Week 48
Change From Baseline in Isovolumic Relaxation Time (IVRT) at Week 24
+30 more

CADENCE Trial Design

5Treatment 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. After completion of the placebo-controlled treatment period, participants will continue to receive sotatercept SC at a dose level of 0.3 mg/kg Q3W in an extension period for up to 18 months.
Group III: Extension Period: Placebo Crossed Over to Sotatercept 0.3 mg/kg, escalating to 0.7 mg.kgExperimental Treatment1 Intervention
After the placebo-controlled treatment period, placebo participants will cross over to receive 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 then Q3W for up to 18 months in an extension period.
Group IV: Extension Period: Placebo Crossed Over to Sotatercept 0.3 mg/kgExperimental Treatment1 Intervention
After the placebo-controlled treatment period, placebo participants will cross over to receive sotatercept SC at a dose of 0.3 mg/kg Q3W for up to 18 months in an extension period.
Group V: PlaceboPlacebo Group1 Intervention
Delivered subcutaneously (SC) every 3 weeks (Q3W) for 24 weeks in the placebo-controlled treatment period. After completion of the placebo-controlled treatment period, placebo participants will enter into 1 of the 2 sotatercept dose groups in an extension period.

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: Extension Period: Placebo Crossed Over to Sotatercept 0.3 mg/kg, Sotatercept 0.3 mg/kg, escalating to 0.7 mg.kg, Extension Period: Placebo Crossed Over to 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many distinct places is this research being conducted?

"Presently, this research is being conducted in 38 different locations, which include cities such as Liverpool, Phoenix and Jacksonville. If you wish to enroll and minimize travel, it would be best to select the location nearest you."

Answered by AI

Are there specific requirements to qualify for this clinical trial?

"This phase 3 clinical trial is looking for 150 patients that have hypertension and meet the following criteria: -Chronic medication for HF or for any underlying condition, administered at a stable (per investigator) dose for ≥30 days prior to Visit 1. Diuretics and/or anticoagulants are excepted from this rule but should not be newly started or stopped within 30 days of Visit 1, and a prescribed dose change should not occur within 7 days of Visit 1. Anticoagulation may be suspended for RHC if necessary.-Have 2 negative urine or serum pregnancy tests as verified by the investigator"

Answered by AI

How many total test subjects are in this experiment?

"One hundred and fifty patients are required to complete this study. The sponsor, Acceleron Pharma Inc., which is a subsidiary of Merck Sharp and Dohme (itself a subsidiary of Merck & Co., Inc.), will run the trial from multiple locations including Pulmonary Health Physicians in Liverpool, New york and PULMONARY ASSOCIATES, P.A. in Phoenix, Arizona."

Answered by AI

What are the precedents for this research?

"Since 2021, Sotatercept has been the subject of 4 clinical trials involving 700 patients total. It received Phase 3 approval after the first trial in 2021 and is currently being studied in 182 cities across 28 countries."

Answered by AI

Are researchers looking for more people to participate in this trial?

"This clinical trial, the details of which can be found on clinicaltrials.gov, is recruiting patients at this time. The study was first posted on December 29th 2021 and was edited most recently on October 28th 2022."

Answered by AI

Does this research include elderly participants?

"Eligibility requirements for this trial state that patients must be between 18 and 85 years old. There are 84 other trials available for those under 18 and 1,405 options for people over 65."

Answered by AI

What other medical research has been conducted using Sotatercept?

"There are 4 on-going studies researching Sotatercept with the majority of these trials (3/4) being in Phase 3. The trial locations for Sotatercept are primarily in Edmonton, Alberta; however, there are 492 total clinical trial sites for this medication."

Answered by AI

Is Sotatercept a reliable treatment option?

"While there is some evidence that suggests Sotatercept is safe, as this is only a Phase 2 trial, more data needs to be collected before efficacy can be determined."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
Indiana
What site did they apply to?
Cedars Sinai Medical Center ( Site 1082)
Ascension Medical Group St. Vincent ( Site 1076)
Froedtert Hospital & the Medical College of Wisconsin ( Site 1051)
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
2

Why did patients apply to this trial?

You tube. Talks of clinical trials. I've been on meds for 3 yes now and had a mitral valve clip that made me worse. I'd like to better my quality of life. I'm only 53.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study of Sotatercept for the Treatment of Cpc-PH Due to HFpEF (MK-7962-007/A011-16)
2021. "A Study of Sotatercept for the Treatment of Cpc-PH Due to HFpEF (MK-7962-007/A011-16)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04945460.
All > Heart Failure With Preserved Ejection Fraction > Pulmonary Hypertension
~59 spots leftby Oct 2025
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