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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 is a clinical trial that has completed, run by Duke University. The registered enrollment target is 100 participants.

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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

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2012-07
Est. Completion 2014-12

Sponsor

Duke University

1,725 total trials

What the Registry Record Tells You About NCT01646541

The ClinicalTrials.gov registry entry for NCT01646541 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT01646541 reports 0 study locations.

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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