Status:
COMPLETED
A Proof of Concept Study of Electrical Discharge Produced Nitric Oxide for Inhalation
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Hypertension, Pulmonary
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
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 PA...
Detailed Description
Background. Inhaled nitric oxide is routinely used to treat acute pulmonary hypertension in infants, children and adults. By 2014 it has been estimate about 500,000 US patients have been treated with ...
Eligibility Criteria
Inclusion
- FIRST PART OF THE STUDY: HEALTHY VOLUNTEER STUDY (n=6 volunteers)
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02305550
Start Date
April 1 2015
End Date
January 1 2016
Last Update
February 10 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114