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NCT01729611 · ClinicalTrials.gov registry record
Endothelial Function in Patients With Scleroderma or Cirrhosis With and Without Pulmonary Hypertension
A clinical trial, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- 119
- Enrollment target
NCT01729611: Completed study, sponsored by The Cleveland Clinic.
NCT01729611 is a clinical trial that has completed, run by The Cleveland Clinic. The registered enrollment target is 119 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01729611 has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- 119 participants
- Enrollment target
Study 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.
Primary Outcome
Baseline characteristics in patients with and without PAH will be compared using parametric (t-test) and non parametric (Mann-Whitney) tests for continuous data and Chi-square for categorical data.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2013-12 |
| Est. Completion | 2021-04 |
What the finished NCT01729611 record still lists
NCT01729611 is an observational study that tracks outcomes without assigning an intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01729611 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01729611 about?
NCT01729611 is a clinical study titled "Endothelial Function in Patients With Scleroderma or Cirrhosis With and Without Pulmonary Hypertension". 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 ...
What is the current status of trial NCT01729611?
This trial is currently completed. The enrollment target is 119 participants. The study started on 2013-12. Estimated completion is 2021-04.
Who is sponsoring clinical trial NCT01729611?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
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