Trial · NCT05825417

Pulmonary Hypertension: Intensification and Personalisation of Combination Rx

NCT05825417, Phase 4, Active not recruiting, Sheffield Teaching Hospitals NHS Foundation Trust

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Pulmonary Hypertension: Intensification and Personalisation of Combination Rx. Trials, record NCT05825417. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05825417

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Pulmonary Hypertension: Intensification and Personalisation of Combination Rx
NCT number: NCT05825417
Status: Active not recruiting
Phases: Phase 4
Enrollment: 70 participants, estimated
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Conditions: Pulmonary Arterial Hypertension
Interventions: Selexipag, Riociguat, CardioMEMS pulmonary artery pressure monitor, Confirm Rx, Sotatercept
First posted: 2023-04-24
Last updated: 2026-08-07

Source ClinicalTrials.gov

Registered outcomes27

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Right Ventricular Stroke Volume (RVSV) flow on each therapy measured by MRI RSVS (flow) on each therapy measured by MRI	Baseline to Week 12 of each crossover period	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
Primary	Daily Hemodynamic Detection of Treatment Response During Sotatercept Escalation	Baseline (Week 0) through Week 24	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.
Secondary	Haemodynamics - Total Pulmonary Resistance (TPR)	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.	Change in TPR (Woods Units) on each therapy to determine clinical efficacy
Secondary	Haemodynamics - mean Pulmonary Artery Pressure (mPAP)	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.	Change in mPAP (mmHg) on each therapy to determine clinical efficacy
Secondary	Haemodynamics - Cardiac Output (CO)	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.	Change in CO (L/min) on each therapy to determine clinical efficacy
Secondary	Haemodynamics - Cardiac Index	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	Change in cardiac index (L/min/m\^2) on each therapy to determine clinical efficacy
Secondary	Haemodynamics - Stroke Volume (SV)	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.	Change in SV (mL) on each therapy to determine clinical efficacy
Secondary	Haemodynamics - Heart Rate (HR)	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.	Change in HR (bpm) on each therapy to determine clinical efficacy
Secondary	6 Minute Walk Test	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.	Change on each therapy to determine clinical efficacy
Secondary	NTpro-BNP	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.	Change on each therapy to determine clinical efficacy

1 to 10 of 27Source ClinicalTrials.gov

See all 27 registered outcomes

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33632769	BACKGROUND

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT05825417

GET https://conductscience.org/api/trials/v1/NCT05825417/registered?page=2

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