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Prognosis in Asymptomatic Mitral Regurgitation (PAMIR) Study

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00509080
First Posted: July 31, 2007
Last Update Posted: July 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Schweizerische Herzstiftung
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
  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

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 ]
    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.


Biospecimen Retention:   Samples Without DNA
Blood samples

Estimated Enrollment: 200
Study Start Date: April 2006
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2017 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00509080


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

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00509080     History of Changes
Other Study ID Numbers: PAMIR
First Submitted: July 30, 2007
First Posted: July 31, 2007
Last Update Posted: July 27, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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