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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 belowSelect...
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:Select...
I have a BMI of 50 or more, severe sleep apnea, and conditions that prevent me from walking.
Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 24
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 moreTrial 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.
Management of Pulmonary Arterial Hypertension.
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You need to take two pregnancy tests before starting the study drug to confirm that you are not pregnant. You will also need to take pregnancy tests regularly during the study and up to 8 weeks after the study drug is finished.I have a BMI of 50 or more, severe sleep apnea, and conditions that prevent me from walking.I am between 18 and 85 years old.I am following the required pregnancy prevention measures.If you have sex with a male partner, you must use reliable birth control for at least 28 days before starting the study drug. You must also use two forms of birth control (a reliable method and a barrier method) during the study period and up to 16 weeks after stopping the study drug.My heart failure medication dose has been stable for over 30 days.I don't have a history of specific heart conditions, major surgeries, chronic liver disease, or recent drug trials.I can understand and agree to participate in the study.My heart failure or other condition medication dose has been stable for over 30 days, except for water pills or blood thinners.I am between 18 and 85 years old.I have heart-related health issues.I agree to use contraception and not donate blood or sperm.My heart pumps well, with an ejection fraction of 50% or higher, and it has never been below 45%.I have been diagnosed with pulmonary hypertension.I have a serious lung condition like COPD or interstitial lung disease.My heart and lung tests show specific pressures and I can walk at least 100 meters.Your PCWP is between 15 and 30 mmHg.My heart pumps well and has never been weak in consecutive tests.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Sotatercept 0.3 mg/kg, escalating to 0.7 mg.kg
- Group 2: Sotatercept 0.3 mg/kg
- Group 3: Placebo
Awards:
This trial has 0 awards, including:Pulmonary Hypertension Patient Testimony for trial: Trial Name: NCT04945460 — Phase 2