Ignite Creation Date:
2024-05-06 @ 1:04 AM
Last Modification Date:
2024-10-26 @ 10:59 AM
Study NCT ID:
NCT01729611
Status:
COMPLETED
Last Update Posted:
2021-04-02
First Post:
2012-11-15
Brief Title:
Endothelial Function in Patients With Scleroderma or Cirrhosis With and Without Pulmonary Hypertension
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Endothelial Function in Patients With Scleroderma or Cirrhosis With and Without Pulmonary Hypertension
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pulmonary arterial hypertension PAH is a condition characterized by an increased pulmonary vascular resistance that can lead to right heart failure and death Several diseases are known etiologies of PAH including scleroderma and cirrhosis The presence of PAH in the context of systemic sclerosis or cirrhosis has a dramatic impact on prognosis and survival of the connective tissue or liver disease
Despite advances in the diagnosis of PAH echocardiography remains a necessary test for screening PAH in patients with scleroderma or cirrhosis However echocardiography is less than ideal for diagnosing PAH and predicting treatment response Thus there is a pressing need to identify methodologies that can accurately and non-invasively recognize the presence of PAH in patients with scleroderma and cirrhosis
Hypothesis
1 To measure endothelial function and exhaled gases in patients with scleroderma and cirrhosis To assess whether they correlate with the presence or the development of PAH
2 The degree of local forearm capillary vasodilation during treprostinil iontophoresis identifies patients who will develop PAH and in those already diagnosed PAH predicts response to PAH-specific therapies
Despite advances in the diagnosis of PAH echocardiography remains a necessary test for screening PAH in patients with scleroderma or cirrhosis However echocardiography is less than ideal for diagnosing PAH and predicting treatment response Thus there is a pressing need to identify methodologies that can accurately and non-invasively recognize the presence of PAH in patients with scleroderma and cirrhosis
Hypothesis
1 To measure endothelial function and exhaled gases in patients with scleroderma and cirrhosis To assess whether they correlate with the presence or the development of PAH
2 The degree of local forearm capillary vasodilation during treprostinil iontophoresis identifies patients who will develop PAH and in those already diagnosed PAH predicts response to PAH-specific therapies
Detailed Description:
Patients with scleroderma are known to have endothelial dysfunction and limited data suggested an association between the degree of endothelial function in scleroderma and the presence of PAH However these data is preliminary and has not been used to predict response to PAH-specific therapy or the development of PAH We will test patients with cirrhosis because they tend to have PAH in the context of a hyperdynamic instead of a hypodynamic state as observed in scleroderma and PAH
Aims
1 To measure endothelial function and exhaled gases in patients with scleroderma or cirrhosis to assess whether they correlate with the presence or the development of PAH
2 To evaluate the degree of endothelial response to local treprostinil iontophoresis and determine if this test can predict the development of pulmonary hypertension or response to PAH-specific therapies
Aims
1 To measure endothelial function and exhaled gases in patients with scleroderma or cirrhosis to assess whether they correlate with the presence or the development of PAH
2 To evaluate the degree of endothelial response to local treprostinil iontophoresis and determine if this test can predict the development of pulmonary hypertension or response to PAH-specific therapies
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