NCT03841344: RESPIRE

Repeatability and Sensitivity to Change of Non-invasive Endpoints in PAH

Status unknown NA Last updated 18 February 2019

What this trial tests

NA trial testing MRI in Pulmonary Arterial Hypertension in 44 participants. Status unknown.

Timeline

15 September 2015

Primary endpoint
24 September 2018

20 May 2019

Quick facts

Lead sponsor	University of Sheffield
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	single
Primary purpose	diagnostic
Enrollment	44
Start date	15 September 2015
Primary completion	24 September 2018
Estimated completion	20 May 2019

Drugs / interventions tested

• MRI — full drug profile →

Conditions studied

• Pulmonary Arterial Hypertension — all drugs for Pulmonary Arterial Hypertension →

Sponsor

University of Sheffield

Who can join

Eligibility, any sex, with Pulmonary Arterial Hypertension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Pulmonary arterial hypertension (PAH) is progressive life limiting disease with a median survival of less than 3 years without treatment. Current drug trials in PAH commonly use simple tests for example the 6-minute walk test, blood tests such as N-terminal pro-brain-type natriuretic peptide (NT-pro-BNP) and BNP, and haemodynamic measures such as PAP and PVR obtained by RHC as endpoints. These tests are surrogate markers of disease severity in patients with pulmonary hypertension. There is now evidence suggesting that magnetic resonance imaging (MRI) may be helpful in the follow up of patients with PAH with high accuracy for the detection of treatment failure, this is because MRI can track changes occurring in the heart by direct visualisation of cardiopulmonary morphology and function, an advantage over existing methods. However, the reproducible of MRI measurements in patients with PAH is not known, and the comparative repeatability of MRI in relation to traditional candidate endpoints such as walk tests and blood tests used in drug trials is not known.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Validation of Artificial Intelligence Cardiac MRI Measurements: Relationship to Heart Catheterization and Mortality Prediction.
   Alabed S, Alandejani F, Dwivedi K, Karunasaagarar K, et al · · 2022 · cited 27× · PMID 35699578 · DOI 10.1148/radiol.212929
2. Training and clinical testing of artificial intelligence derived right atrial cardiovascular magnetic resonance measurements.
   Alandejani F, Alabed S, Garg P, Goh ZM, et al · · 2022 · cited 20× · PMID 35387651 · DOI 10.1186/s12968-022-00855-3
3. Repeatability and sensitivity to change of non-invasive end points in PAH: the RESPIRE study.
   Swift AJ, Wilson F, Cogliano M, Kendall L, et al · · 2021 · cited 12× · PMID 33632769 · DOI 10.1136/thoraxjnl-2020-216078
4. Semi-automatic thresholding of RV trabeculation improves repeatability and diagnostic value in suspected pulmonary hypertension.
   Macdonald A, Salehi M, Alabed S, Maiter A, et al · · 2022 · cited 1× · PMID 36684562 · DOI 10.3389/fcvm.2022.1037385