Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03841344
Recruitment Status : Unknown
Verified February 2019 by Andy J Swift, University of Sheffield.
Recruitment status was:  Active, not recruiting
First Posted : February 15, 2019
Last Update Posted : February 18, 2019
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Andy J Swift, University of Sheffield

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Device: MRI Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: A Prospective Study Comparing the REpeatability and Sensitivity to Change of Non-invasive Endpoints in Pulmonary arterIal hypeRtEnsion
Actual Study Start Date : September 15, 2015
Actual Primary Completion Date : September 24, 2018
Estimated Study Completion Date : May 20, 2019


Arm Intervention/treatment
Active Comparator: Healthy volunteers
MRI 6 minute walk test, incremental shuttle walk test, NT-Pro BNP and BNP
Device: MRI
Evaluation of the utility of candidate endpoints in PAH trials
Other Name: 6 minute walk test, incremental shuttle walk test, NT-ProBNP and BNP

Active Comparator: Treatment naive patients

MRI 6 minute walk test, incremental shuttle walk test, NT-Pro BNP and BNP

Patients diagnosed with PAH initiating PAH therapy for the first time

Device: MRI
Evaluation of the utility of candidate endpoints in PAH trials
Other Name: 6 minute walk test, incremental shuttle walk test, NT-ProBNP and BNP

Active Comparator: Treatment change patients

MRI 6 minute walk test, incremental shuttle walk test, NT-Pro BNP and BNP

Patients diagnosed with PAH, currently on PAH therapy who are undergoing an escalation of PAH therapy

Device: MRI
Evaluation of the utility of candidate endpoints in PAH trials
Other Name: 6 minute walk test, incremental shuttle walk test, NT-ProBNP and BNP

Active Comparator: Stable patients

MRI 6 minute walk test, incremental shuttle walk test, NT-Pro BNP and BNP

Patients with PAH who are NOT undergoing changes in their treatment regime

Device: MRI
Evaluation of the utility of candidate endpoints in PAH trials
Other Name: 6 minute walk test, incremental shuttle walk test, NT-ProBNP and BNP




Primary Outcome Measures :
  1. Repeatability of endpoints [ Time Frame: Measurements repeated within 24 hours ]
    Repeatability of MRI, 6 minute walk test, incremental shuttle walk test, NT-Pro BNP and BNP

  2. Sensitivity to change of endpoints [ Time Frame: Follow up visits performed at 1-12 months ]
    Sensitivity to change of MRI, 6 minute walk test, incremental shuttle walk test, NT-Pro BNP and BNP



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Patients with PAH

Inclusion Criteria:

  • PAH subject is diagnosed with Group 1 pulmonary arterial hypertension, including IPAH, hereditable and CTD, and PAH associated with portal hypertension
  • Mean pulmonary arterial pressure ≥ 25 mmHg
  • Pulmonary arterial wedge pressure ≤ 15 mmHg

Exclusion Criteria:

  • Inability to perform the study protocol
  • Significant comorbidity where in the opinion of the clinician this is a significant contributor to the patients PAH
  • Pregnancy
  • Allergy to contrast medium
  • Contraindication to MRI (as per standard screening questionnaire)
  • Significant lung disease.
  • Known Hep B,C, HIV

Healthy volunteers

Inclusion criteria:

  • Male or female aged between 18 years and 60 years
  • Currently healthy as determined by a responsible physician
  • No significant history of lung or cardiac disease and normal BNP.
  • Capable of giving written informed consent.
  • Subject is >50kg with a body mass index within the range 18.0 to 32kg/m2.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Andy J Swift, Wellcome Trust Clincial Research Career Development Fellow - principle investigator, University of Sheffield
ClinicalTrials.gov Identifier: NCT03841344    
Other Study ID Numbers: STH18285
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pulmonary Arterial Hypertension
Familial Primary Pulmonary Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases