Clinical trial of Nitric Oxide inhalation therapy in patients with severe PH

Phase 2

Recruiting

• Conditions: Pulmonary arterial hypertension (PAH), and Chronic thromboembolic pulmonary hypertension (CTEPH); PH, Nitric oxide, PAH, CTEPH, Right heart failure; D006976

• Registration Number: JPRN-jRCT2051220042
• Lead Sponsor: Ogo Takeshi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-09
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1) Patients who are at least 18 years of age at the time consent is obtained
2) Patients with pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH)
3) Patients who meet all of the following criteria for right heart catheterization
1) Mean pulmonary artery pressure greater than 25 mmHg
2) Pulmonary capillary wedge pressure or left ventricular end-diastolic pressure less than 15 mmHg
3) Pulmonary vascular resistance greater than 3 Wood units
4) WHO-FC III or higher
5) Patients with fluid retention (fluid retention on physical examination or echocardiographic evidence of congestion), low cardiac output (cardiac coefficient less than 2.5 L/min/m2 ), or in need of inotropic drugs
6) Patients with written consent from the patient

Exclusion Criteria

1) Patients with cardiac disease (Eisenmenger's syndrome) who are completely dependent on a right-left shunt for life support
2) Patients with PAH who are eligible for Calcium channel blockers
3) Patients with pulmonary veno-occlusive disease
4) Patients with pulmonary capillary haemangiomatosis
5) Patients with pulmonary hypertension due to left heart disease
6) Patients with pulmonary hypertension due to pulmonary disease and/or hypoxia
7) Patients with pulmonary hypertension with un clear and/or multifactorial mechanisms
8) Patients with a history of hypersensitivity to the investigational drug
9) Pregnant or lactating women, or patients who cannot consent to contraception during the study
10) Patients who plan to participate in other clinical trials or interventional studies during the period of this study
11) Patients who are judged by the investigator or subinvestigator to be inappropriate to participate in this clinical trial for other reasons.

Study & Design

• Study Type: Interventional
• Study Design: Not specified