A Proof of Concept Study of Electrical Discharge Produced Nitric Oxide for Inhalation
Completed · Not applicable
Conditions studied: Hypertension, Pulmonary
In brief
Study Design: This is a two-part physiological for a device feasibility. Both studies are proof of concept descriptive pilot studies. The FIRST PART is a study of healthy volunteers and the SECOND PART of patients with pulmonary hypertension at routine cardiac catheterization laboratory (CATH-LABORATORY). Volunteers and patients will be enrolled sequentially; there is no group randomization. Overall hypothesis of this device feasibility study: To test a lightweight and portable method of synthesizing therapeutic levels of inhaled nitric oxide from air by electrical pulsed discharge.
Key facts
- Study ID
- NCT02305550
- Run by
- Massachusetts General Hospital
- People needed
- 12
- Starts
- 2015-04-01
- Expected to finish
- 2016-01-01
- Last updated by the study team
- 2017-02-10
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Have a government photo identity card;
- Age < 40 years old;
- Body mass index (BMI) <28 kg/m2 and >18 kg/m2;
- Feel well the day of nitric oxide testing;
- Normal physical exam
You may not qualify if…
- Psychiatric disturbances such as anxiety, depression, schizophrenia requiring pharmacological treatment or hospitalization in the last year;
- Systemic disease with or without any functional limitation; including controlled hypertension and controlled diabetes without systemic effects;
- Pregnancy determined by urine pregnancy test, detecting presence of human chorionic gonadotropin, or less than six weeks postpartum;
- Active smoking, volunteers may be enrolled if they quit smoking for more than 1 year;
- Excess alcohol use: more than ½ L/day of wine consumption or equivalent;
- Any current use of a medication other than: Over-the-counter oral medications, herbal remedies, nutritional supplements, and oral contraceptives;
- Currently enrolled in another research study.
- SECOND PART OF THE STUDY: CATH-LABORATORY STUDY (n=6 cath laboratory subjects)
- Inclusion criteria:
- Have a government photo identity card;
- Diagnosis of Pulmonary Arterial Hypertension, Group I, III, IV and V, as defined by the National Heart Lung and Blood Institute classification.
- Known positive responder to inhaled nitric oxide
- Wedge pressure ≤15 mmHg at baseline
- Pulmonary arterial pressure (mean) greater than or equal to 40 mmHg
- Scheduled Cath Lab testing for right heart catheterization to assess pulmonary vasodilator capacity
- Exclusion Criteria:
- Psychiatric disturbances such as anxiety, depression, schizophrenia requiring pharmacological treatment or hospitalization in the last year;
- Pregnancy determined by urine pregnancy test, detecting presence of human chorionic gonadotropin, or less than six weeks postpartum;
- Left ventricular failure for which breathing nitric oxide is contraindicated;
- Patients with diagnosis of congenital or acquired methemoglobinemia reductase deficiency;
- Currently enrolled in another research study.
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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