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NCT01646541 · ClinicalTrials.gov registry record
Symptomatic Pulmonary Arterial Hypertension After Mitral Valve Surgery
A clinical trial, sponsored by Duke University.
- Completed
- Registry status
- 100
- Enrollment target
NCT01646541: Completed study, sponsored by Duke University.
NCT01646541 is a clinical trial that has completed, run by Duke University. The registered enrollment target is 100 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01646541 has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- 100 participants
- Enrollment target
Study Summary
Most patients with mitral valve disease are symptomatic with shortness of breath and a limited activity level prior to mitral valve surgery. Despite surgical repair or replacement of the mitral valve, many patients remain symptomatic with an impaired ability to live an active lifestyle. Often after extensive evaluation, no other pulmonary, left ventricular dysfunction, or valvular heart disease is responsible for the continued symptoms, and some of these patients will be limited by persistent pulmonary hypertension (PH) at rest or with exertion that is responsible for limiting their activity level and impacting their quality of their life. It is our goal in the proposed study to systematically characterize symptomatic and asymptomatic patients greater than six months after mitral valve surgery using clinical data, echocardiographic evaluation, laboratory assessment, and in some patients, invasive hemodynamic measurements. The investigators will screen asymptomatic and symptomatic patients with resting echocardiography and also with echocardiography during exercise, as many patients will exhibit exercise-induced PH following mitral valve surgery. Pulmonary artery (PA) pressure will be estimated from echocardiography using Doppler-derived calculations. If elevated PA pressures are observed with echocardiography, then symptomatic patients will undergo right heart catheterization for invasive pressure measurement, which is the gold-standard for the diagnosis of PH. When PH is present and there is a normal wedge pressure (PCWP) during invasive pressure measurement, further assessment to identify potential candidates for PH therapy will be performed. This involves having patients breathe inhaled nitric oxide, a rapid-acting, pulmonary vasodilator with a short half-life. While breathing inhaled nitric oxide, blood pressure, PA pressure, PCWP, and cardiac output will be monitored to characterize individuals who could benefit symptomatically from pharmacotherapy to treat un
Primary Outcome
study evaluation period will take several hours to complete the components of the study (clinical evaluation, echocardiogram, etc.) on approximately 2 occasions
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2012-07 |
| Est. Completion | 2014-12 |
What the finished NCT01646541 record still lists
NCT01646541 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01646541 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01646541 about?
NCT01646541 is a clinical study titled "Symptomatic Pulmonary Arterial Hypertension After Mitral Valve Surgery". Most patients with mitral valve disease are symptomatic with shortness of breath and a limited activity level prior to mitral valve surgery. Despite surgical repair or replacement of the mitral valve, many patients remain symptomatic with an impaired ability to live an active lifestyle. Often after ...
What is the current status of trial NCT01646541?
This trial is currently completed. The enrollment target is 100 participants. The study started on 2012-07. Estimated completion is 2014-12.
Who is sponsoring clinical trial NCT01646541?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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