Comparison of Vasodilator Response of Inhaled Epoprostenol and Inhaled Nitric Oxide

Mass General Brigham

Status and phase: Completed; Phase 4

Conditions: Pulmonary Hypertension

Treatments: Drug: Vasodilator testing (Inhaled Nitric Oxide); Drug: Vasodilator testing (Inhaled Epoprostenol)

Study type: Interventional

Funder types: Other

Identifiers

NCT04231084

2019P003491

Details and patient eligibility

About

The overarching goal of this study is to examine the acute vasoreactive response to both inhaled nitric oxide and inhaled epoprostenol across both traditionally and non-traditionally interrogated phenotypes in PH, and to further characterize the relationship of vasoreactivity to disease severity and PH phenotype.

Enrollment: 115 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• mPAP ≥ 21mmHg, PAWP ≤ 25mmHg, and PVR ≥3 WU
• Classified as WHO group I-III pulmonary hypertension

Exclusion criteria

• WHO group IV and V pulmonary hypertension
• Patients who are on baseline pulmonary vasodilator medications
• Severe aortic or mitral valve disease
• Patients who are pregnant
• Left ventricular ejection fraction of <35%
• Patients who are hospitalized as inpatients at the time of RHC
• Patients with systolic blood pressure <90mmHg or mean arterial pressure of < 60mmHg

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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115 participants in 2 patient groups

Inhaled Nitric Oxide

Active Comparator group

Description:

Vasodilator testing will be performed with inhaled nitric oxide

Treatment:

Drug: Vasodilator testing (Inhaled Nitric Oxide)

Inhaled Epoprostenol

Experimental group

Description:

Vasodilator testing will be performed with inhaled epoprostenol

Treatment:

Drug: Vasodilator testing (Inhaled Epoprostenol)