Pulmonal hypertension: intensivering og personalisering af kombinations-Rx (PHoenix)
4. august 2026 opdateret af: Sheffield Teaching Hospitals NHS Foundation Trust
Et multicenter randomiseret cross-over-forsøg med sygdomsspecifik terapi hos patienter med pulmonal arteriel hypertension (PAH) implanteret med pulmonalarterietryk og hjerterytmemonitoreringsanordninger (CardioMEMS/ConfirmRx)
Målet med dette kliniske forsøg er at evaluere kapaciteten af implanterbar/fjernteknologi til tidlig evaluering af lægemiddelbehandlinger hos patienter med pulmonal arteriel hypertension (PAH).
Hovedspørgsmålet, det sigter mod at besvare, er, om strukturerede ændringer i klinisk terapi vil kunne påvises ved hjælp af implanterede reguleringsgodkendte enheder.
Deltagerne vil blive implanteret med godkendt medicinsk udstyr og vil indgå i en undersøgelse af godkendte lægemidler for at vurdere fysiologi, aktivitet og patientrapporterede livskvalitetsresultater (QoL).
Forskere vil sammenligne to terapeutiske strategier i hver enkelt patient for at se, om undersøgelsens design giver tilstrækkelig evidens til at personalisere medicinbehandlingsplaner
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
I denne undersøgelse vil patienter etableret på vejledende anbefalet terapi blive implanteret med enheder, og fjernovervågning etableret.
Patienterne vil derefter indgå i et 2x2 crossover-studie af godkendte lægemidler, hvor der vil blive udført standard kliniske undersøgelser ved baseline og maksimal behandling af hvert lægemiddel.
Cross-over-designet vil give flere stigninger og fald af lægemidler, der vides at ændre hæmodynamikken og 6MWT.
Undersøgelsen er drevet til at detektere forbedring i højre ventrikulær slagvolumen målt ved MRI fra baseline til maksimal behandling for hvert lægemiddel.
Det vil derefter blive fastslået, om ændringer i fjernovervågede mål giver en tidlig indikation af klinisk effekt sammenlignet med MRI, hæmodynamik, NTproBNP og 6MWT foretaget efter 12 uger.
Fjernmåling af hæmodynamik i de to perioder med deeskalering vil informere forståelsen af fysiologi og informere klinisk praksis.
Sammenligningen af de to terapeutiske strategier hos individuelle patienter i en undersøgelse vil lette nye kliniske undersøgelsesdesign og give evidens for datadrevet personlig medicin i området.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
70
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Sheffield, Det Forenede Kongerige, S10 2JF
- Sheffield Teaching Hospitals NHS FT
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
- Kan give informeret samtykke
- Alder 18-80 år
- PAH, som er idiopatisk, arvelig eller forbundet med lægemidler, toksiner eller bindevævssygdomme
- Stabil PAH terapeutisk regime omfattende enhver kombination af ERA og PDE5i i mindst 1 måned før screening (medmindre ude af stand til at tolerere terapi)
- WHO funktionsklasse III
- Hvilende mPAP ≥20 mmHg, pulmonært kapillært kiletryk ≤15 mmHg, pulmonal vaskulær modstand ≥2 træenheder målt ved højre hjertekateterisering på tidspunktet for diagnosen
- 6MWT >50m ved indsejling
- Estimeret glomerulær filtrationshastighed (eGFR)>30 ml/min/1,73 m² ved indgang (bilag C)
- Utilstrækkelig behandlingsrespons (klinisk bestemt)
Ekskluderingskriterier:
- Kan ikke give informeret samtykke
- Graviditet
- Uprovokeret lungeemboli (til enhver tid)
- Akut infektion på tidspunktet for screening (genscreening er tilladt)
- PAH på grund af human immundefektvirus, portal hypertension, schistosomiasis, medfødt hjertesygdom
- Pulmonal hypertension på grund af venstre hjerte, lunge, tromboembolisk eller uklar/multifaktoriel sygdom (Gruppe II-V)
- Ude af stand til at tolerere aspirin eller P2Y12-hæmmer
- Overfølsomhed over for selexipag eller riociguat
- Klinisk signifikant nyresygdom (eGFR≤30 ml/min/1,73m2)
- Anæmi (hæmoglobin <10 g/dl)
- Venstre-sidet hjertesygdom og/eller klinisk signifikant hjertesygdom, herunder men ikke begrænset til nogen af følgende: aorta- eller mitralklapsygdomme større end mild aorta-insufficiens; mild aortastenose; mild mitralstenose; eller moderat mitral regurgitation
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: Arm A (selexipag/riociguat)
Baseline - etableret PDE/ERA terapi Uge 1 - påbegynd OPA (PDE/ERA/OPA terapi) Uge 2-12 - optitrering af OPA til maksimal terapi (PDE/ERA/OPA terapi) Uge 13-14 - reducer OPA (PDE/ERA) /OPA terapi) Uge 15 - udvaskning OPA (PDE/OPA terapi) Uge 16 - udvaskning PDE (ERA terapi) Uge 17 - påbegynd sGCS (ERA/sGCS terapi) Uge 18-27 - optitrering af sGCS til maksimal terapi (ERA/sGCS terapi)
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If Arm A - Optitrering til maksimal tolereret dosis efterfulgt af deeskalering If Arm B - Optitrering til maksimal tolereret dosis efterfulgt af observation, modifikation eller overgang efter skøn fra ansvarligt plejeteam, hvor det er nødvendigt.
Andre navne:
If Arm A - Optitrering til maksimal tolereret dosis efterfulgt af deeskalering If Arm B - Optitrering til maksimal tolereret dosis efterfulgt af observation, modifikation eller overgang efter skøn fra ansvarligt plejeteam, hvor det er nødvendigt.
Andre navne:
Implantation og fjernovervågning etableret med patientinitierede daglige aflæsninger
Implantation og fjernovervågning etableret med automatiske daglige aflæsninger/downloads
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Aktiv komparator: Arm B (riociguat/selexipag)
Baseline - etableret PDE/ERA-terapi Uge 1 - udvaskning PDE (kun ERA-terapi) Uge 2 - påbegynd sGCS (ERA/sGCS-terapi) Uge 3-12 - optitrering af sGCS til maksimal terapi (ERA/sGCS-terapi) Uge 13 - reducer sGCS (ERA/sGCS terapi) Uge 14 - reducere og udvaske sGCS (ERA terapi) Uge 15 - påbegynde PDE (PDE/ERA terapi) Uge 16 - påbegynde OPA (PDE/ERA/OPA terapi) Uge 17-27 - optitrering af OPA til maksimal terapi (PDE/ERA/OPA terapi)
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If Arm A - Optitrering til maksimal tolereret dosis efterfulgt af deeskalering If Arm B - Optitrering til maksimal tolereret dosis efterfulgt af observation, modifikation eller overgang efter skøn fra ansvarligt plejeteam, hvor det er nødvendigt.
Andre navne:
If Arm A - Optitrering til maksimal tolereret dosis efterfulgt af deeskalering If Arm B - Optitrering til maksimal tolereret dosis efterfulgt af observation, modifikation eller overgang efter skøn fra ansvarligt plejeteam, hvor det er nødvendigt.
Andre navne:
Implantation og fjernovervågning etableret med patientinitierede daglige aflæsninger
Implantation og fjernovervågning etableret med automatiske daglige aflæsninger/downloads
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Aktiv komparator: Arm C : Sotatercept
Baseline - established background therapy; initiate sotatercept 0.3 mg/kg Week 3 - evaluate safety parameters (Hb/platelets) & uptitrate sotatercept to target dose 0.7 mg/kg . Weeks 6, 9, 12, 15, 18, 21 - maintenance sotatercept 0.7 mg/kg every 3 weeks with safety monitoring Week 24 - final maintenance dose and endpoint assessments |
Implantation og fjernovervågning etableret med patientinitierede daglige aflæsninger
Implantation og fjernovervågning etableret med automatiske daglige aflæsninger/downloads
Subcutaneous injection of sotatercept administered once every 3 weeks for 24 weeks.
Treatment is initiated at a starting dose of 0.3 mg/kg at Week 0 and escalated at Week 3 to a target maintenance dose of 0.7 mg/kg, contingent on body weight, clinical response, and pre-dose safety parameters (haematoglobin and platelet counts).
Maintenance dosing at 0.7 mg/kg continues every 3 weeks through Week 21, alongside continuous daily remote hemodynamic and physiological monitoring via implanted CardioMEMS and cardiac rhythm devices.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Right Ventricular Stroke Volume (RVSV) flow on each therapy measured by MRI RSVS (flow) on each therapy measured by MRI
Tidsramme: Baseline to Week 12 of each crossover period
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This provides a robust, objective assessment of clinical efficacy which, if met, will mean that a change in therapy has provided a clinically meaningful change in physiology
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Baseline to Week 12 of each crossover period
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Daily Hemodynamic Detection of Treatment Response During Sotatercept Escalation
Tidsramme: Baseline (Week 0) through Week 24
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Within-patient changes in continuous, remote-monitored Total Pulmonary Resistance (TPR), mean Pulmonary Artery Pressure (mPAP), Cardiac Output (CO), Stroke Volume (SV), and Heart Rate (HR) detected by the CardioMEMS sensor following treatment escalation with sotatercept, correlated with end-of-treatment RVSV measured by cardiac MRI.
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Baseline (Week 0) through Week 24
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Haemodynamics - Total Pulmonary Resistance (TPR)
Tidsramme: Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks.
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Change in TPR (Woods Units) on each therapy to determine clinical efficacy
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Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks.
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Haemodynamics - mean Pulmonary Artery Pressure (mPAP)
Tidsramme: Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks.
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Change in mPAP (mmHg) on each therapy to determine clinical efficacy
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Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks.
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Haemodynamics - Cardiac Output (CO)
Tidsramme: Part 1 : From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks.
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Change in CO (L/min) on each therapy to determine clinical efficacy
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Part 1 : From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks.
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Haemodynamics - Cardiac Index
Tidsramme: Part 1 : From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks
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Change in cardiac index (L/min/m^2) on each therapy to determine clinical efficacy
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Part 1 : From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks
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Haemodynamics - Stroke Volume (SV)
Tidsramme: Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks.
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Change in SV (mL) on each therapy to determine clinical efficacy
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Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks.
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Haemodynamics - Heart Rate (HR)
Tidsramme: Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks.
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Change in HR (bpm) on each therapy to determine clinical efficacy
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Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks.
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6 Minute Walk Test
Tidsramme: Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks.
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Change on each therapy to determine clinical efficacy
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Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks.
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NTpro-BNP
Tidsramme: Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks.
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Change on each therapy to determine clinical efficacy
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Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks.
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MRI - Right Ventricular Ejection Fraction (RVEF)
Tidsramme: Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks
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RVEF (%) on each therapy to determine clinical efficacy
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Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks
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MRI - Right Ventricular End Systolic Volume (RVESV)
Tidsramme: Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks
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RVESV (mL/m^2) on each therapy to determine clinical efficacy
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Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks
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MRI - Right Ventricular End Diastolic Volume (RVEDV)
Tidsramme: Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks
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RVEDV (mL/m^2) on each therapy to determine clinical efficacy
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Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks
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MRI - Right Ventricular Stroke Volume (RVSV)
Tidsramme: Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks
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RVSV (mL) on each therapy to determine clinical efficacy
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Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks
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MRI - Left Ventricular Volume Fraction (LVEF)
Tidsramme: Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks
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LVEF (%) on each therapy to determine clinical efficacy
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Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks
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MRI - Left Ventricular End Systolic Volume (LVESV)
Tidsramme: Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks
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LVESV (mL/m^2) on each therapy to determine clinical efficacy
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Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks
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MRI - Left Ventricular End Diastolic Volume LVEDV
Tidsramme: Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks
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LVEDV (mL/m^2) on each therapy to determine clinical efficacy
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Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks
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MRI - Left Ventricular Stroke Volume (LVSV)
Tidsramme: Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks
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LVSV (mL) on each therapy to determine clinical efficacy
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Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks
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MRI - Left Ventricular Stroke Volume (LVSV) flow
Tidsramme: Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks
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LVSV flow on each therapy to determine clinical efficacy
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Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks
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Patient Reported Outcomes (PRO) - Quality of Life (QoL) (EmPHasis-10)
Tidsramme: Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks
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Change of QoL score on each therapy to determine clinical efficacy.
This will be done using EmPHasis-10 questionnaire (10 questions using a 0 (poor) - 5 (good) scale)
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Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks
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Patient Reported Outcomes (PRO) - Medication Compliance (PHoenix PRO)
Tidsramme: Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks
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Change of medication compliance score on each therapy to determine clinical efficacy.
This will be done using PHoenix PRO questionnaire (10 questions using a 0 (poor) - 5 (good) scale)
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Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks
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Patient Reported Outcomes (PRO) - Medication Side Effects
Tidsramme: Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks
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Change of medication side effects on each therapy to determine clinical efficacy.
This will be done using PHoenix Medication side effects questionnaires (4 Yes/No or Better/Worse style questions)
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Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks
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Patient Reported Outcomes (PRO) - Depression symptoms (GAD-2/7)
Tidsramme: Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks
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Change of depression symptoms on each therapy to determine clinical efficacy.
This will be done using the GAD-2/7 questionnaire (2 screening questions to determine if symptoms present.
If present, 7 additional questions to determine level of depression using a 0 (not at all) - 3 (nearly every day) scale)
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Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks
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Patient Reported Outcomes (PRO) - Anxiety symptoms (PHQ-2/9)
Tidsramme: Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks
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Change of anxiety symptoms on each therapy to determine clinical efficacy.
This will be done using the PHQ-2/9 questionnaire (2 screening questions to determine if symptoms present.
If present, 9 additional questions to determine level of anxiety using a 0 (not at all) - 3 (nearly every day) scale)
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Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks
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WHO functional class
Tidsramme: Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks
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Change on each therapy to determine clinical efficacy.
Functional assessment of PAH will be made according to the WHO classification system: Class I - Patients with PAH without limitation of physical activity.
Ordinary physical activity does not cause increased dyspnoea or fatigue, chest pain, or near syncope / Class II - Patients with PAH resulting in slight limitation of physical activity.
No discomfort at rest.
Normal physical activity causes increased dyspnoea or fatigue, chest pain, or near syncope / Class III - Patients with PAH resulting in marked limitation of physical activity.
There is no discomfort at rest.
Less than ordinary activity causes increased dyspnoea or fatigue, chest pain, or near syncope / Class IV - Patients with PAH with inability to carry out any physical activity without discomfort.
Indications of manifest right heart failure.
Dyspnoea and/or fatigue may even be present at rest.
Discomfort is increased by the least physical activity.
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Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks
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EuroQoL-5D-5L
Tidsramme: Part 2 only : From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks
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The EuroQoL-5D-5L is included for future health economic evaluation of sotatercept.
(free for non-commercial use
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Part 2 only : From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks
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PHoenix UTAUT questionnaire
Tidsramme: Part 1 only: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks
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Evaluation of remote monitoring technology and devices.
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Part 1 only: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Alexander Rothman, MD / PhD, University of Sheffield
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
14. juni 2023
Primær færdiggørelse (Anslået)
1. januar 2028
Studieafslutning (Anslået)
1. januar 2028
Datoer for studieregistrering
Først indsendt
24. marts 2023
Først indsendt, der opfyldte QC-kriterier
11. april 2023
Først opslået (Faktiske)
24. april 2023
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
7. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. august 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- STH21653
- MR/W026279/1 (Andet bevillings-/finansieringsnummer: UKRI Medical Research Council)
- 325120 (Anden identifikator: IRAS)
- MISP 102663 (Andet bevillings-/finansieringsnummer: MERCK SHARP & DOHME(UK) LIMITED [MSD])
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
Forskningsprøver vil blive overført til Sheffield Biorepository uden identificerbare personlige data.
Data vil blive indsamlet og hostet og behandlet af University of Oxford (dataleverandør). Autoriserede dataophavsmænd omfatter, men er ikke begrænset til PI'er og delegeret personale; Deltagere; og Core Imaging Laboratory. Prøvelederen vil lede dataverifikationsprocessen. Fjernovervågningsdata vil blive administreret gennem Merlin.net system (Enhedsleverandør - Abbott). Pseudonymiserede data vil derefter blive overført, opbevaret, analyseret og arkiveret sikkert på University of Glasgow (behandler). Data vil også blive overført til University of Sheffield og Newcastle University (processor) til undersøgelsesanalyse.
University of Sheffield skal eje alle rettigheder, titel og interesser i og til alle University of Sheffield-data. I forbindelse med databeskyttelseslovgivningen er Sheffield Teaching Hospitals (sponsor) den dataansvarlige.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ja
produkt fremstillet i og eksporteret fra U.S.A.
Ja
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