Ignite Creation Date:
2024-05-06 @ 12:15 AM
Last Modification Date:
2024-10-26 @ 10:46 AM
Study NCT ID:
NCT01523548
Status:
WITHDRAWN
Last Update Posted:
2017-06-09
First Post:
2012-01-27
Brief Title:
Carbon Monoxide Therapy for Severe Pulmonary Arterial Hypertension
Sponsor:
University of Illinois at Chicago
Organization:
University of Illinois at Chicago
Study Overview
Official Title:
Carbon Monoxide Therapy for Severe Pulmonary Arterial Hypertension
Status:
WITHDRAWN
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of funding and subject acuity
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CO in PAH
Brief Summary:
The purpose of this study is to examine the potential of carbon monoxide CO to decrease elevated blood pressure in the pulmonary artery This symptom is seen in patients with pulmonary arterial hypertension a rare disease that causes fatigue dizziness and shortness of breath because the blood vessels that supply the lungs narrow forcing the heart to work harder to push blood through Previous studies in the laboratory have shown that carbon monoxide has promise in treating these symptoms
Subjects in this study are being asked to undergo a new type of treatment to improve pulmonary arterial hypertension by breathing CO gas CO is a colorless tasteless odorless gas usually found in car exhaust or cigarette smoke It is administered with a continuous flow of air Subjects will undergo a screening process during which it will be determined if they are eligible for the study After the screening process if subjects meet eligibility criteria for the study they will begin carbon monoxide treatment through a cushioned mask that is placed over the nose and mouth This treatment will last for sixteen weeks
Subjects in this study are being asked to undergo a new type of treatment to improve pulmonary arterial hypertension by breathing CO gas CO is a colorless tasteless odorless gas usually found in car exhaust or cigarette smoke It is administered with a continuous flow of air Subjects will undergo a screening process during which it will be determined if they are eligible for the study After the screening process if subjects meet eligibility criteria for the study they will begin carbon monoxide treatment through a cushioned mask that is placed over the nose and mouth This treatment will last for sixteen weeks
Detailed Description:
Pulmonary arterial hypertension PAH remains an uncommon debilitating and fatal disease and is clinically marked by a progressive increase in pulmonary vascular resistance leading to right heart failure and ultimately death Currently the treatment options available for those suffering from PAH target cellular dysfunction that leads to constriction of the vasculature Although there is some evidence that available therapies have secondary effects on vascular remodeling there are currently no therapies that target abnormal cell proliferation in PAH
Carbon monoxide CO is a gaseous molecule with known toxicity and lethality to living organisms when exposed to high concentrations for sustained periods However CO has shown promise in preclinical models of pulmonary hypertension Recent studies have shown that mammalian cells have the ability to generate endogenous CO primarily through the catalysis of heme by the heme oxygenase enzymatic system and there is ample evidence demonstrating that CO behaves as a signaling molecule in cellular and biological processes Furthermore CO has been demonstrated to exert key physiological and protective functions in various models of tissue inflammation and injury
This study will evaluate the safety and potential efficacy of inhaled CO in subjects with severe PAH Over forty subjects with severe PAH despite best available therapy will be screened from the UIC pulmonary vascular disease clinic of which twenty subjects will be recruited for participation in the trial The trial will consist of an initial screening period to determine subjects eligibility for the study This will be based on a previous echocardiogram a six minute walk test and right heart catheterization done as part of standard care for subjects with pulmonary arterial hypertension Following the initial screening the trial will last sixteen weeks during which subjects will receive inhaled carbon monoxide up to three times weekly at the University of Illinois at Chicago
Carbon monoxide CO is a gaseous molecule with known toxicity and lethality to living organisms when exposed to high concentrations for sustained periods However CO has shown promise in preclinical models of pulmonary hypertension Recent studies have shown that mammalian cells have the ability to generate endogenous CO primarily through the catalysis of heme by the heme oxygenase enzymatic system and there is ample evidence demonstrating that CO behaves as a signaling molecule in cellular and biological processes Furthermore CO has been demonstrated to exert key physiological and protective functions in various models of tissue inflammation and injury
This study will evaluate the safety and potential efficacy of inhaled CO in subjects with severe PAH Over forty subjects with severe PAH despite best available therapy will be screened from the UIC pulmonary vascular disease clinic of which twenty subjects will be recruited for participation in the trial The trial will consist of an initial screening period to determine subjects eligibility for the study This will be based on a previous echocardiogram a six minute walk test and right heart catheterization done as part of standard care for subjects with pulmonary arterial hypertension Following the initial screening the trial will last sixteen weeks during which subjects will receive inhaled carbon monoxide up to three times weekly at the University of Illinois at Chicago
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| K23HL098454 | NIH | None | httpsreporternihgovquickSearchK23HL098454 |