Prognosis in Asymptomatic Mitral Regurgitation (PAMIR) Study

This study is currently recruiting participants.
Verified April 2013 by University Hospital, Basel, Switzerland
Sponsor:
Collaborator:
Schweizerische Herzstiftung
Information provided by (Responsible Party):
Christian Müller, MD, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00509080
First received: July 30, 2007
Last updated: April 9, 2013
Last verified: April 2013
  Purpose

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.


Condition
Mitral Regurgitation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prognosis in Asymptomatic Mitral Regurgitation (PAMIR) Study

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Composite of congestive heart failure, decompensated heart failure and valve surgery [ Time Frame: 360 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples Without DNA

Blood samples


Estimated Enrollment: 200
Study Start Date: April 2006
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Detailed Description:

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 therapy and may therefore reassure a "wait and see strategy".

Patients and methods: The prospective cohort study is designed to enrol 200 patients with severe mitral regurgitation and followed over a 4-year period. Natriuretic peptides including BNP and NT-proBNP will be measured in addition to detailed clinical, electrocardiographic, and echocardiographic assessment prospectively and repetitively in patients with severe mitral regurgitation during routine consultations at 6 months intervals. Our primary analysis (longitudinal study) will focus on the prognosis in asymptomatic patients. In addition, a sub-study will also include symptomatic patients with severe mitral regurgitation whether or not they are scheduled to undergo valvular surgery (cross sectional study) in order to obtain more reliable data regarding BNP/NT-proBNP levels in patients with a formal indication for valvular surgery. The treating physician will remain blinded to the BNP/NT-proBNP values. In this cohort study, we will try to identify a BNP/NT-proBNP cut-off values that predict major adverse cardiac events including cardiac death, congestive heart failure, myocardial infarction, or persistent left ventricular systolic dysfunction at 6 months after valvular surgery.

Clinical Significance: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients admitted to the participating centers

Criteria

Inclusion Criteria:

  • Patients with severe isolated mitral regurgitation due to valvular disease

Exclusion Criteria:

  • Missing written patient consent
  • Active infective endocarditis
  • Relative mitral regurgitation due to left ventricular disease
  • Other moderate to severe dysfunctional valve
  • Previous cardiac surgery
  • Pregnancy
  • Sepsis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00509080

Contacts
Contact: Christian Mueller, Prof. 0041 61 265 2525 MuellerChr@uhbs.ch
Contact: Mihael Potocki, MD 0041 61 265 2525 potockim@uhbs.ch

Locations
Germany
Herz-Zentrum Bad Krozingen Recruiting
Bad Krozingen, Germany, 79189
Principal Investigator: Nikolaus Jander, MD         
Kerkhoff Klinik Recruiting
Bad Nauheim, Germany, 61231
Principal Investigator: Michael Weber, MD         
Cardiology Praxis Dr. Gekeler Recruiting
Loerrach, Germany, 79540
Switzerland
University Hospital of Basel Recruiting
Basel, Switzerland
Principal Investigator: Christian Mueller, Prof.         
Cardiology Praxis Prof. A. Hoffmann Recruiting
Basel, Switzerland, 4052
Cardiology Praxis Dr. Cron/ Dr. Hess Recruiting
Basel, Switzerland, 4051
Sponsors and Collaborators
Christian Müller, MD
Schweizerische Herzstiftung
Investigators
Principal Investigator: Christian Mueller, Prof. University Hospital, Basel, Switzerland
  More Information

No publications provided

Responsible Party: Christian Müller, MD, Prof. Dr. med., University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00509080     History of Changes
Other Study ID Numbers: PAMIR
Study First Received: July 30, 2007
Last Updated: April 9, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Basel, Switzerland:
mitral regurgitation
BNP
NT-proBNP
natriuretic peptides
valvular heart disease

Additional relevant MeSH terms:
Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014