129 Xenon MRI as a Biomarker for Diagnosis and Response to Therapy in Pulmonary Arterial Hypertension (PAH) : 129 Xenon MRI as a Biomarker for Diagnosis and Response to Therapy in Pulmonary Arterial Hypertension (PAH)

Subject Enrollment This study will consent and enroll 20 subjects total.• For Arm 1, 10 subjects with Idiopathic Pulmonary Arterial Hypertension (IPAH) will be consented and enrolled. For Arm 2, 10 subjects with Connective Tissue Disease Associated Pulmonary Arterial Hypertension (PAH-CTD) will be consented and enrolled.Study Design This study will be observational. Subjects in both arms of the trial will undergo a 129Xe MRI/MRS at timepoints of baseline, 3 months, 6 months, and 12 months. In addition to the this, data from standard of care assessments, such as labs, echocardiography, and six-minute walk distance (6MWD), will also collected at these timepoints.Primary Study Endpoints The primary endpoint for this trial will be the change in defect + low percentage of RBC signal on hyperpolarized 129Xe MRI from baseline to 12 monthsSecondary Study EndpointsThere will be several secondary endpoints for this trial:Change in regional and global RBC Oscillation Amplitudes on hyperpolarized 129Xe MR spectroscopy from baseline to 12 monthsChange in 6MWD from baseline to 12 monthsChange in NTproBNP from baseline to 12 monthsChange in WHO FC from baseline to 12 monthsPrimary Safety EndpointsThere will be several primary safety endpoints for this trial:Frequency of Adverse Events (AE) and/or Serious Adverse Events (SAE)Withdrawals due to adverse event or deathIncidence of Adverse Events of Significant Interest (AESI):Electrocardiogram and any findingsPhysical examination and vital signs.

Medienart:	Klinische Studie

Erscheinungsjahr:	2024
Erschienen:	2024

Enthalten in:	ClinicalTrials.gov - (2024) vom: 21. März Zur Gesamtaufnahme - year:2024

Sprache:	Englisch

Links:	Volltext [kostenfrei]

Themen:	610 Connective Tissue Diseases Disease Familial Primary Pulmonary Hypertension Hypertension Phase: Phase 2 Pulmonary Arterial Hypertension Recruitment Status: Not yet recruiting Study Type: Interventional

Anmerkungen:	Source: Link to the current ClinicalTrials.gov record., First posted: October 27, 2023, Last downloaded: ClinicalTrials.gov processed this data on March 27, 2024, Last updated: March 27, 2024

Study ID:	NCT06104228 Pro00113893
Veröffentlichungen zur Studie:

fisyears:
Förderinstitution / Projekttitel:

PPN (Katalog-ID):	CTG000131873