Right Ventricular Compensation With Sotatercept: A Prospective Single Arm Open Label Phase 4 Study to Evaluate the Effects of Sotatercept on Right Ventricular Function in Pulmonary Arterial Hypertension (RECOMPENSE)
Recruiting
Phase 4Interventional Study
Pulmonary Arterial Hypertension PAHPulmonary Arterial Hypertension WHO Group IPulmonary Arterial Hypertension
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 70
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
Amsterdam UMC, location VUmc · Other
Who this trial is looking for
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Pulmonary arterial hypertension (PAH) is a progressive disease characterized by vascular remodelling resulting in elevated pressures in the pulmonary artery (PA). This elevated pressure ultimately leads to fulminant right heart failure. Current therapeutic options are limited and are centred around vasodilatory medications such as phosphodiesterase-5 inhibitors and prostacyclin. While these medica…
Pulmonary arterial hypertension (PAH) is a progressive disease characterized by vascular remodelling resulting in elevated pressures in the pulmonary artery (PA). This elevated pressure ultimately leads to fulminant right heart failure. Current therapeutic options are limited and are centred around vasodilatory medications such as phosphodiesterase-5 inhibitors and prostacyclin. While these medications allow for the widening of blood vessels that are narrowed due to remodelling, they have no effect on the remodelling itself.
Sotatercept is a novel medication which targets the BMPR2/TGF-β pathway and restore a pro- and anti- proliferative balance to ultimately counteract vascular remodelling. Recent phase 2 and 3 trials showed that treatment with sotatercept led to lower resistance and pressure in the pulmonary vasculature and improved exercise tolerance. However, these results were not coupled with an increase in cardiac output, a change that is seen with other PAH-medications with a primarily vasodilatory effect. These results suggest that cardiac work is reduced and cardiac efficiency is improved in patients being treated with sotatercept, in contrast with conventional PAH therapies. This is a potentially beneficial effect that may result in improved disease control in the long-term. Our study aims to explore the effect of sotatercept on cardiac work and function. We hypothesize that the effects of sotatercept are more beneficial for cardiac function than that of traditional PAH medications.
All participants included in the trial will undergo a screening visit in which it will be checked that all inclusion criteria and no exclusion criteria are met. The screening visit involves a physical exam, blood draw, 6-minute walk test, right heart catheterization (RHC) and cardiac magnetic resonance imaging (cMRI) with contrast to assess fibrosis.
Upon inclusion, all participants will receive a subcutaneous injection of sotatercept starting at a dose of 0.3 mg/kg. Participants will return to the hospital every three weeks for a blood draw, physical examination and an adverse event review. If the laboratory values (specifically haemoglobin and platelet counts) stay stable after the first dose, the dosage will be escalated to 0.7 mg/kg. The dose will not be escalated beyond 0.7 mg/kg.
After 24 weeks of receiving sotatercept, there will be an end of treatment visit including a physical exam, 6-minute walk test, right heart catheterization (RHC) and cardiac magnetic resonance imaging (cMRI) with contrast material.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Adult patients between 18-70 years of age
2. Able to provide signed informed consent
3. WHO FC II to IV
4. NTproBNP \> 300 ng/L
5. PAH etiology belonging to one of the following groups (Nice classification):
* Idiopathic PAH
* Heritable PAH
6. Hemodynamic diagnosis …
Inclusion Criteria:
1. Adult patients between 18-70 years of age
2. Able to provide signed informed consent
3. WHO FC II to IV
4. NTproBNP \> 300 ng/L
5. PAH etiology belonging to one of the following groups (Nice classification):
* Idiopathic PAH
* Heritable PAH
6. Hemodynamic diagnosis of PAH confirmed by RHC during screening showing:
* mPAP \> 20 mmHg
* Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) ≤ 15 mmHg
* PVR ≥ 4WU (320 dyn.sec.cm-5)
7. For patients treated with oral diuretics, treatment dose must have been stable at least 1 month prior to RHC during the screening period
8. All patients are on stable background therapy at least 3 months prior to RHC during the screening period
9. Women of childbearing potential must have a negative pregnancy test at screening and agree to use reliable methods of contraception
10. Males must agree to use a condom during sexual contact with a pregnant female or female of childbearing potential while participating in the study. Males should refrain from donating blood or sperm for the duration for the study and for 16 weeks after last dose of sotatercept
Exclusion Criteria:
1. Any contraindication to treatment with sotatercept
2. Body weight \< 40 kg
3. Body mass index (BMI) \> 35kg/m2
4. Pregnancy, breastfeeding, or intention to become pregnant during the study
5. Recently started (\< 8 weeks prior to informed consent signature) or planned cardio-pulmonary rehabilitation program
6. Known concomitant life-threatening disease with a life expectancy \< 12 months
7. Any condition likely to affect protocol or treatment compliance
8. Hospitalization for PAH within 3 months prior to informed consent signature
9. Left atrial volume per body surface area ≥ 43mL/m2 by echocardiography or CMR
10. Valvular disease grade 2 or higher
11. History of pulmonary embolism or deep vein thrombosis
12. Documented moderate to severe chronic obstructive pulmonary disease
13. Documented moderate to severe restrictive lung disease
14. Historical evidence of significant coronary artery disease
15. Diabetes mellitus
16. Active cancer
17. Systolic blood pressure \< 90 mmHg
18. Need for dialysis
19. Responders to acute vasoreactivity testing based on medical history
20. Treatment with another investigational drug (planned, or taken within the 3 months prior to study treatment initiation)
21. Claustrophobia
22. Permanent cardiac pacemaker, automatic internal cardioverter
23. Metallic implant (e.g. defibrillator, neurostimulator, hearing aid, infusion device)
24. Atrial fibrillation, multiple premature ventricular or atrial contractions , or any other condition that would interfere with proper cardiac gating during CMR.
25. History of major bleeding
26. Hemoglobin above ULN for age and gender
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