PIMR and Pulmonary Vascular Disease

University of California, Los Angeles (UCLA)

Status: Completed

Conditions: Pulmonary Hypertension

Treatments: Other: Pulmonary artery OCT; Other: Pulmonary Index of Microcirculatory Resistance; Other: Right Ventricle Index of Microcirculatory Resistance

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05843461

IRB#22-001643

Details and patient eligibility

About

The findings from this innovative, first-in-man, prospective pilot study will elucidate the role of PIMR and RV-IMR in pre-capillary PH. The study cohort will consist of patients with pulmonary pressures ranging from normal (advanced lung disease patients undergoing lung transplant evaluation) to severe PH (PAH and CTEPH patients), and thus will allow for identification of a PIMR cutoff. Participants will include: 1) advanced lung disease patients undergoing bilateral heart catheterization as part of their pre-lung transplant work-up, and 2) newly referred patients to PAH and CTEPH clinics undergoing bilateral heart catheterization as part of standard of care work-up. All participants will undergo PIMR testing, and those with pre-capillary PH will also undergo pulmonary OCT and measurement of RV-IMR. The study seeks to define the relationship between PIMR and PH and to establish the PIMR threshold that identifies pulmonary microvascular dysfunction as well as to evaluate the association of PIMR and pulmonary vascular remodeling on OCT in patients with pre-capillary PH. In addition, the study will assess the relationship between RV-IMR and RV pressure overload among patients with pre-capillary PH.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥18 years old
• Able to provide informed written consent.
• Patients with 1) advanced lung disease requiring standard-of-care bilateral heart catheterization as part of lung transplant evaluation in whom mPAP < 20 mmHg on RHC, or 2) PAH/CTEPH (i.e. pre-capillary PH) undergoing standard-of-care bilateral heart catheterization as part of their work-up/treatment

Exclusion criteria

• Contraindicated to undergo fluoroscopy and/or coronary angiography (e.g. pregnancy)
• Chronic kidney disease (serum creatinine ≥ 2.0 mg/dL)

Trial design

30 participants in 3 patient groups

Controls

Description:

10 patients without pulmonary hypertension (mean PA pressure less than 20 mmHg on RHC)

Treatment:

Other: Pulmonary Index of Microcirculatory Resistance

PAH

Description:

10 patients with PAH

Treatment:

Other: Pulmonary artery OCT

Other: Right Ventricle Index of Microcirculatory Resistance

Other: Pulmonary Index of Microcirculatory Resistance

CTEPH

Description:

10 patients with CTEPH

Treatment:

Other: Pulmonary artery OCT

Other: Right Ventricle Index of Microcirculatory Resistance

Other: Pulmonary Index of Microcirculatory Resistance