Role of inhaled Nitric Oxide (NO) before cardiac surgery in patients with Pulmonary Hypertensio

• Conditions: - Cardiac surgery open heart - Pulmonary Hypertension with PAPs> 40 mmHg secondary to left heart disease or COPD (class 2 or 3), diagnosed by preoperative right heart catheterization or transthoracic echocardiography.; MedDRA version: 18.0Level: LLTClassification code 10017501Term: Functional disturbances following cardiac surgerySystem Organ Class: 100000004863; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2014-003338-15-FR
• Lead Sponsor: CHU de Clermont-Ferrand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-18
• Last Update Posted: 25 January 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Age> 18 years
- No exclusion criteria
- Cardiac surgery open heart
- Pulmonary Hypertension with PAPs> 40 mmHg secondary to left heart disease or COPD (class 2 or 3), diagnosed by preoperative right heart catheterization or transthoracic echocardiography.
- Having given their written consent
- Affiliated to Social Security
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

- Heart Transplantation
- Pulmonary Hypertension type 1, 4, 5 as classified by Dana Point 2008
- Deficit in methemoglobin reductase.
- Refusal to protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified