Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Symptomatic Pulmonary Arterial Hypertension After Mitral Valve Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Duke University
Sponsor:
Collaborators:
Northwestern University
Gilead Sciences
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01646541
First received: July 16, 2012
Last updated: September 12, 2014
Last verified: September 2014

July 16, 2012
September 12, 2014
July 2012
December 2015   (final data collection date for primary outcome measure)
Prevalence of pulmonary hypertension [ Time Frame: greater than 6 months after mitral valve surgery ] [ Designated as safety issue: No ]
study evaluation period will take several hours to complete the components of the study (clinical evaluation, echocardiogram, etc.) on approximately 2 occasions
Same as current
Complete list of historical versions of study NCT01646541 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Symptomatic Pulmonary Arterial Hypertension After Mitral Valve Surgery
Symptomatic Pulmonary Arterial Hypertension After Mitral Valve Surgery: Pilot, Screening Study

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 underlying PH. It is important to note that only a small minority of patients exhibit a positive vasodilator response and those with PH and a normal PCWP without an initial vasodilator response would still be identified as candidates for chronic PH therapy.

The information generated from this proposed research will make a significant contribution to the understanding of PH in a group of patients in whom it has not been previously studied. Scientific reports on the evaluation of patients with PH after mitral valve surgery are almost nonexistent from the modern era. Furthermore, patients with PH due to mitral valve disease have been excluded from clinical trials of agents currently approved by the U.S. Food and Drug Administration (FDA) to treat PH. Therefore, this work will carefully characterize PA pressures in an objective manner in a group of patients following mitral valve surgery who remain limited with respect to their activity levels. In addition, the investigators will gain a better understanding of the frequency with which patients have PH and a normal PCWP, which identifies a cohort of patients who could have an improvement in their symptoms and quality of life with chronic vasodilator treatment.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients seen in the cardiology, pulmonary hypertension, or cardiac surgery clinics at the enrolling institutions

  • Pulmonary Hypertension
  • Mitral Valve Disease
Not Provided
  • Asymptomatic
    No dyspnea with exertion greater than 6 months after mitral valve surgery [New York Heart Association (NYHA) Functional Class I]
  • Symptomatic
    Dyspnea with exertion greater than 6 months after mitral valve surgery [New York Heart Association (NYHA) Functional Class II, III, or IV]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2015
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age > 18 years
  • Greater than 6 months post-mechanical or bioprosthetic mitral valve replacement or mitral valve repair (quadrangular resection, triangular resection, sliding plasty, and/or annuloplasty) surgery
  • Dyspnea at rest or with exertion (NYHA II, III, or IV) [Symptomatic Study Group]
  • Asymptomatic control group meeting criteria 1 and 2 above

Exclusion Criteria:

  • Current or prior chronic vasodilator therapy for pulmonary hypertension
  • Known collagen vascular disease
  • HIV infection: Based on self-report /historical diagnosis
  • Portal hypertension
  • Prior anorexigen use
  • History of corrected or uncorrected intracardiac shunt
  • Prior pulmonary embolism
  • Sickle cell disease
  • Left ventricular dysfunction (ejection fraction < 45%)
  • Moderate or severe mitral regurgitation
  • Moderate aortic stenosis (mean gradient > 25 mm Hg)
  • Symptomatic, non-revascularized coronary artery disease
  • Evidence of parenchymal lung disease with a TLC < 70% and an FEV1 < 65% of predicted with pulmonary function testing
  • Pregnancy - Serum pregnancy test for women of child bearing potential, if cardiac catheterization is needed
  • Unable to provide informed consent
Both
18 Years and older
Yes
Contact: Andrew Wang, M.D. 9196816197 a.wang@dm.duke.edu
Contact: Todd Kiefer, M.D. 9196816197 todd.kiefer@duke.edu
United States
 
NCT01646541
Pro00033042
No
Duke University
Duke University
  • Northwestern University
  • Gilead Sciences
Principal Investigator: Andrew Wang, M.D. Duke University
Duke University
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP