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

Pulmonary Arterial Hypertension Clinical Trial

— Xenon PAH Bio  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06104228
• Other study ID #: Pro00113893
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 1, 2024
• Est. completion date: March 31, 2026

Study information

• Verified date: March 2024
• Source: Duke University
• Contact: David Ptashnik, MS
• Phone: 919-668-2642
• Email: david.ptashnik[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overall study objectives outlined in this study are to derive 129Xe MRI pulmonary vascular biomarker signatures that differentiate common subtypes of PAH and to determine the ability of 129Xe MRI to longitudinally monitor disease progression and response to therapy in PAH, with the aid of additional assessments, such as labs, echocardiography, and six-minute walk distance (6MWD).

Description:

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 months Secondary Study Endpoints There 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 months - Change in 6MWD from baseline to 12 months - Change in NTproBNP from baseline to 12 months - Change in WHO FC from baseline to 12 months Primary Safety Endpoints There 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 death - Incidence of Adverse Events of Significant Interest (AESI): - Electrocardiogram and any findings - Physical examination and vital signs

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: March 31, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

Arm 1 -IPAH

• Age: 18-75 years
• WHO functional class 2 or 3
• Mean pulmonary artery pressures > 20 mmHg
• Pulmonary capillary wedge pressure =15 mmHg
• Pulmonary vascular resistance > 2 Wood Units (WU)
• No other cause identified for PAH Arm 2 -PAH-CTD
• Age: 18-75 years
• WHO functional class (FC) 2 or 3
• Mean pulmonary artery pressures > 20 mmHg
• Pulmonary capillary wedge pressure =15 mmHg
• Pulmonary vascular resistance > 2 WU
• Diagnosis of connective tissue disease

Exclusion Criteria:

• PH other than Idiopathic PAH or PAH associated with CTD; any conditions that prevent the performance of 129Xe MRI scans will be excluded from the study.

Related Conditions & MeSH terms

• Connective Tissue Diseases
• Disease
• Familial Primary Pulmonary Hypertension
• Hypertension
• Idiopathic Pulmonary Arterial Hypertension
• Pulmonary Arterial Hypertension

Intervention

Drug:
• 129Xe Hyperpolarized
Each xenon dose will be limited to a volume less than 25% of a subject's total lung capacity (TLC), as is the case for all protocols currently carried out under IND 109490

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Bastiaan Driehuys	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary Vascular Remodeling	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 months	1 year
Secondary	RBC Oscillation Amplitude	• Change in regional and global RBC Oscillation Amplitudes on hyperpolarized 129Xe MR spectroscopy from baseline to 12 months	1 year
Secondary	6 Minute Walk Distance	Change in 6MWD from baseline to month 12	1 Year
Secondary	NTproBNP	Change in NTproBNP from baseline to month 12	1 year
Secondary	World Health Organization (WHO) Functional Class (FC)	Change in WHO FC from baseline to month 12	1 year