Comparison of Inhaled Nitric Oxide and Oxygen in Participants Reactivity During Acute Pulmonary Vasodilator Testing

Cardiomyopathy Clinical Trial

Official title:

Comparison of Supplemental Oxygen and Nitric Oxide for Inhalation Plus Oxygen in the Evaluation of the Reactivity of the Pulmonary Vasculature During Acute Pulmonary Vasodilator Testing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00626028
• Other study ID #: INOT22
• Secondary ID: 2004-000625-30
• Status: Completed
• Phase: Phase 3
• Start date: September 2004
• Est. completion date: February 2010

Study information

• Verified date: September 2016
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this study is to compare the number of participants with reversible pulmonary hypertension (vasoreactivity) due to nitric oxide for inhalation and oxygen as compared to 100% oxygen.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

1. Must have any one of these three disease categories:

• Idiopathic Pulmonary Arterial Hypertension

• Mean pulmonary arterial pressure (PAPm) > 25 millimeters of mercury (mmHg) at rest, pulmonary capillary wedge pressure (PCWP) = 15 mmHg, and PVRI> 3 u•m^2 or diagnosed clinically with no previous catheterization

• Congenital heart disease (CHD) with pulmonary hypertension repaired and unrepaired

• PAPm > 25 mmHg at rest and PVRI> 3 u•m^2 or diagnosed clinically with no previous catheterization

• Cardiomyopathy

• PAPm > 25 mmHg at rest and Pulmonary vascular resistance index (PVRI)> 3 u•m^2 or diagnosed clinically with no previous catheterization

2. Scheduled to undergo right heart catheterization to assess pulmonary vasoreactivity by acute pulmonary vasodilation testing.

3. Male or female, ages 4 weeks to 18 years, inclusive

4. Signed informed consent/assent

Exclusion Criteria:

1. Focal pulmonary infiltrates on chest radiograph.

2. Diagnosed with severe obstructive or restrictive pulmonary disease that is significantly contributing to the patient's pulmonary hypertension.

3. Received treatment with nitric oxide for inhalation within 30 days prior to study initiation, are on other investigational medications, nitroglycerin, sodium nitroprusside, sildenafil, other Phosphodiesterase type 5 (PDE-5) inhibitors, or prostacyclin

4. Pregnant [urine human chorionic gonadotropin positive (HCG +)]

5. Baseline Pulmonary capillary wedge pressure (PCWP) > 20 mmHg

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy
• Familial Primary Pulmonary Hypertension
• Hypertension
• Idiopathic Pulmonary Arterial Hypertension

Intervention

Drug:
• Nitric Oxide for inhalation
Nitric Oxide (NO) for inhalation, given at 80ppm over 10 minutes using an INOvent® delivery system
• Oxygen
100% oxygen (O2) for inhalation, given at 80ppm over 10 minutes using an INOvent® delivery system
• Nitric Oxide plus Oxygen
Nitric Oxide (NO) for inhalation plus oxygen, given at 80ppm over 10 minutes using an INOvent® delivery system

Locations

Country	Name	City	State
France	CHU Timone - Département de cardiologie	Marseille
France	Hôpital d'Enfants	Nancy
France	Hôpital NECKER - Enfants Malades	Paris
Netherlands	Beatrix Children's Hospital / University Hospital Groningen	Groningen
Spain	Hospital Sant Joan de Déu de Barcelona	Barcelona
Spain	Unidad de Cardiologia Infantil - Hospital Vall d'Hebrón	Barcelona
Spain	Hospital Gregorio Maranon	Madrid
Spain	Instituto Pediátrico del Corazón - Hospital Materno Infatil Doce de Octubre	Madrid
United Kingdom	Royal Brompton Hospital	London
United Kingdom	Southampton University Hospitals Trust - Wessex Cardiothoracic Centre	Southampton
United States	Children's Hospital Boston	Boston	Massachusetts
United States	The Medical University of South Carolina	Charleston	South Carolina
United States	Cincinnati Children's Hospital	Cincinnati	Ohio
United States	Columbus Children's Hospital	Columbus	Ohio
United States	The Children's Hospital	Denver	Colorado
United States	New York Presbyterian Hospital	New York	New York
United States	St. Louis Children's Hospital	Saint Louis	Missouri
United States	Lucile Salter Packard Children's Hospital at Stanford	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Mallinckrodt

Countries where clinical trial is conducted

United States,  France,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Reversible Pulmonary Hypertension (Vasoreactivity)	A composite of hemodynamic measurements were used to identify reversible pulmonary hypertension (vasoreactivity)	on Day 1
Secondary	Number of Participants With Related Surgical Procedures Within 1 Year	Number of participants who received surgery for pulmonary or cardiac disease within 1 year after treatment.	within 1 year
Secondary	Number of Participants With Adverse Events (AEs)	An AE was defined as any untoward medical occurrence. An AE need not have a causal relationship with treatment and included any event that was not seen at baseline or, if present at baseline, increased in severity.	on Day 1
Secondary	Number of Participants With Serious Adverse Events (SAEs)	SAEs were collected during the 12 hours after discontinuation of gas or discharge (whichever came first). An SAE was defined as any event that resulted in death, was life threatening, resulted in permanent disability or incapacity, required or prolonged inpatient hospitalization, or was a congenital anomaly. Important medical events that, without medical or surgical intervention, would also have resulted in one of the outcomes listed above were also considered as SAEs.	within 12 hours
Secondary	Number of Participants With Related Surgical Procedures Within 3 Years	Number of participants who received surgery related to pulmonary or cardiac disease within 3 years	within 3 years