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Novel Index (PIMR) in PAH

Purpose

The chief regulator of resistance in pulmonary arterial hypertension (PAH) is the small arteries. In the heart, the invasive measurement of the resistance of the small arteries has been shownto be safe, easy, reliable, and prognostic. This study is intended to translate prior work in heart arteries to the PAH space and invasively measure the resistance of the small arteries of the lung (pulmonary index of microcirculatory resistance [PIMR]) and the coronary artery supplying the right ventricle (acute marginal of the RCA; RV-IMR). Importantly, these measurements will be made during standard of care cardiac catheterizations (right heart catheterization [RHC] +/- left heart catheterization). The correlation between these new indices and the standard ones measured during RHC typically used to determine the severity of pulmonary hypertension will be analyzed. In addition, among newly diagnosed patients, the study will evaluate how these indices change 6 months after starting treatment. Finally, the association of these indices with clinical outcomes at 1 year will be assessed. The findings from this study may deliver an immediate impact to patient care by identifying a new metric to help better identify those who may benefit from a more intensive, personalized treatment regimen.

Condition

Pulmonary Hypertension

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Diagnosis of Group 1 PAH with invasive pulmonary hypertension defined as: Mean pulmonary arterial pressure ≥ 20 mmHg, pulmonary capillary wedge pressure < 15 mmHg, and pulmonary vascular resistance ≥ 3 Wood units. - Serum creatinine < 2.0 mg/dL - Able to provide informed written consent

Exclusion Criteria

Other groups/forms of pulmonary hypertension (i.e. groups 2-5) - Contraindicated to undergo fluoroscopy and/or coronary angiography - Pregnancy

Study Design

Phase
Study Type: Observational
Observational Model: Cohort
Time Perspective: Prospective

Arm Groups

Arm	Description	Assigned Intervention
PAH Patients	Pulmonary Index of Microcirculatory Resistance (PIMR) and Right Ventricle Index of Microcirculatory Resistance (RV-IMR) measurements during standard-of-care right +/- left heart catheterization at baseline and among those who undergo a standard-of-care right heart catheterization at 6 months.	Other: Pulmonary Index of Microcirculatory Resistance PIMR measurement involves placing a coronary pressure wire in the pulmonary arteries and making pressure/time measurements during maximal flow down the artery. Other names: PIMR Other: Right Ventricle Index of Microcirculatory Resistance RV-IMR measurement involves placing a coronary pressure wire in the acute marginal branch of the right coronary artery and making pressure/time measurements during maximal flow down the artery. Other names: RV-IMR

Recruiting Locations

More Details

NCT ID: NCT05812976
Status: Completed
Sponsor: University of California, Los Angeles

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.