Nailfold Capillaroscopy in Pulmonary Hypertension

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will compare nailfold videocapillaroscopy findings with right heart catheterization pressures in adults with pulmonary hypertension (group 1, 3, or 4). It will also explore whether vascular abnormalities seen in nailbeds respond to PH-targeted therapies. The research aims to see if a noninvasive scan could reflect disease severity and treatment response across different PH subtypes. Inpatients and outpatients meeting criteria may undergo serial nailfold imaging alongside standardPH assessments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

For inpatient enrolment:

* Suspected diagnosis of group 1,3 or 4 pulmonary hypertension undergoing inpatient assessment at nationally designated centre
* Age \> 18 years

For follow up scanning of those enrolled as an inpatient:

* Confirmed diagnosis of pulmonary hypertension assessed at nationally designated centre fulfilling criteria for group 1, 3 or 4 disease
* Commencing PH targeted therapy, specifically one or more of: a phosphodiesterase 5 inhibitor (PDE5i), an ET receptor antagonist (ERA), parenteral prostanoid therapy, selexipag, riociguat, sotatercept.

For outpatient enrolment

* Confirmed diagnosis of pulmonary hypertension assessed at nationally designated centre fulfilling criteria for group 1, 3 or 4 disease
* Age \> 18 years
* Escalating PH targeted therapy, specifically one or more of: a phosphodiesterase 5 inhibitor (PDE5i), an ET receptor antagonist (ERA), parenteral prostanoid therapy, selexipag, riociguat, sotatercept.

Target of \> 25% of patients recruited at diagnosis and to have an SSc-spectrum disorder fulfilling either ACR/EULAR 2013 or VEDOSS (very early diagnosis of SSc) criteria.

Target of \> 25% of patients recruited at diagnosis and to have non-SSc group 1 (PAH) diagnosis (as determined by national MDT decision).

Exclusion Criteria:

* Patients with confirmed group 2 or group 5 pulmonary hypertension
* Patients \< 18 years of age
* Patients unable to participate in nailbed microscopy (through e.g. amputation, severe contractures or other musculoskeletal issues).
* (From follow up) Patients not being commenced on pulmonary vasodilator therapy at the point of diagnosis.
* Patients already on maximal PH therapy
* Patients lacking capacity to consent to participation
* Patients who are non-fluent English speakers, where suitable translation cannot be found within a time frame that makes the study feasible.
* Patients with a life expectancy \< 4 months
* Patients who have consumed nicotine or caffeine within the last 4 - 6 hours
* Patients wearing nail polish / varnish/ extensions that preclude adequate nailbed visualisation.

Where it's running

• NHS Golden Jubilee
  Clydebank, West Dunbartonshire, United Kingdom Recruiting

Study contacts

• Principal investigator: Alistair C Church, PhD, BSc, MB ChB, FRCP — University of Glasgow / NHS Greater Glasgow and Clyde
• Study coordinator: William J Kerrigan, BA BMBCh MRCP
• Email: w.kerrigan.1@research.gla.ac.uk
• Phone: 0141 951 5497

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.