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Clinical Trials/jRCT2051220042
jRCT2051220042
Active, not recruiting
Not Applicable

A Single-Center, Randomised, Controlled Trial of the Efficacy and Safety of Inhaled Nitric Oxide therapy in the patients with severe right heart failure due to pulmonary hypertension

Not provided0 sites30 target enrollmentStarted: November 2, 2022Last updated:
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Overview

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
30
Primary Endpoint
-
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Randomized Controlled Trial
Intervention Model
Parallel Assignment
Primary Purpose
Treatment Purpose
Masking
Open(masking Not Used)

Eligibility Criteria

Ages
18age old over to No limit (—)
Sex
All

Inclusion Criteria

  • •Patients who are at least 18 years of age at the time consent is obtained
  • •Patients with pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH)
  • •Patients who meet all of the following criteria for right heart catheterization
  • •Mean pulmonary artery pressure greater than 25 mmHg
  • •Pulmonary capillary wedge pressure or left ventricular end-diastolic pressure less than 15 mmHg
  • •Pulmonary vascular resistance greater than 3 Wood units
  • •WHO-FC III or higher
  • •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
  • •Patients with written consent from the patient

Exclusion Criteria

  • •Patients with cardiac disease (Eisenmenger's syndrome) who are completely dependent on a right-left shunt for life support
  • •Patients with PAH who are eligible for Calcium channel blockers
  • •Patients with pulmonary veno-occlusive disease
  • •Patients with pulmonary capillary haemangiomatosis
  • •Patients with pulmonary hypertension due to left heart disease
  • •Patients with pulmonary hypertension due to pulmonary disease and/or hypoxia
  • •Patients with pulmonary hypertension with un clear and/or multifactorial mechanisms
  • •Patients with a history of hypersensitivity to the investigational drug
  • •Pregnant or lactating women, or patients who cannot consent to contraception during the study
  • •Patients who plan to participate in other clinical trials or interventional studies during the period of this study

Outcomes

Primary Outcomes

-

Efficacy: Change in Pulmonary vascular resistance (PVR) at 30 minutes after inhalation of study drug

Secondary Outcomes

  • Catheter findings(Change from screening time point to each time point (Day 1, Day 2, Day 3))
  • SF36(Change to each time point (Day 3, Day 7, Day 8))

Investigators

Sponsor
Not provided

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