Clinical Trial: Prognosis in Asymptomatic Mitral Regurgitation (PAMIR) Study

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: Prognosis in Asymptomatic Mitral Regurgitation (PAMIR) Study

Brief Summary: The purpose of this study is to determine if the use of BNP/NT-proBNP levels in the detection of early left ventricular dysfunction and damage may improve the timing of cardiac surgery and therefore the long-term management of asymptomatic patients with severe mitral regurgitation.

Detailed Summary:

Background: One of the most difficult issues in the care of asymptomatic patients with severe valvular heart disease, particularly mitral regurgitation, is the timing of the surgical intervention. Unlike the stenotic lesions, regurgitant lesions often progress insidiously, causing left ventricular damage before symptoms develop. Current criteria for surgical intervention include left ventricular dimensions and left ventricular ejection fraction. The clinical problem is that once these morphologic criteria are fulfilled, the prognosis has already worsened, even if surgery is performed promptly. In addition, the onset of symptoms may be difficult to detect because of physical inactivity or under-reporting. In some patients, it may be unclear whether symptoms are related to valvular heart disease or other conditions.

Natriuretic peptides including B-type natriuretic peptide (BNP) and NT-proBNP may be more sensitive markers of left ventricular damage than morphologic studies such as echocardiography. The use of BNP or NT-proBNP levels may help timing the surgical intervention before irreversible left ventricular damage has occurred. Previous experience with BNP and NT-proBNP testing in patients with valvular heart disease is limited, albeit promising.

Aim: To test the hypotheses that:

  • Elevated BNP/NT-proBNP levels reflect early left and right ventricular dysfunction indicating imminent congestive heart failure and cardiac decompensation, and call for surgical intervention.
  • The BNP/NT-proBNP level is a more sensitive marker of ventricular damage than ventricular dimensions and left ventricular ejection fraction.
  • Low BNP/NT-proBNP levels indicate a low event rate with medical the
    Sponsor: University Hospital, Basel, Switzerland

    Current Primary Outcome:

    • Composite of congestive heart failure, decompensated heart failure and valve surgery [ Time Frame: 360 days ]
      Elevated BNP/NT-proBNP levels reflect early left and right ventricular dysfunction indicating imminent congestive heart failure and cardiac decompensation, and call for surgical intervention.
    • Composite of congestive heart failure, decompensated heart failure and valve surgery [ Time Frame: 720 days ]
      Elevated BNP/NT-proBNP levels reflect early left and right ventricular dysfunction indicating imminent congestive heart failure and cardiac decompensation, and call for surgical intervention.


    Original Primary Outcome:

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: University Hospital, Basel, Switzerland

    Dates:
    Date Received: July 30, 2007
    Date Started: April 2006
    Date Completion: December 2017
    Last Updated: July 11, 2016
    Last Verified: July 2016