NCT00509080

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2006

Longer than P75 for all trials

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 31, 2007

Completed
16.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

February 28, 2025

Status Verified

February 1, 2025

Enrollment Period

17.7 years

First QC Date

July 30, 2007

Last Update Submit

February 25, 2025

Conditions

Keywords

mitral regurgitationBNPNT-proBNPnatriuretic peptidesvalvular heart disease

Outcome Measures

Primary Outcomes (2)

  • Composite of congestive heart failure, decompensated heart failure and valve surgery

    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.

    360 days

  • Composite of congestive heart failure, decompensated heart failure and valve surgery

    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.

    720 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients admitted to the participating centers

You may qualify if:

  • Patients with severe isolated mitral regurgitation due to valvular disease

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Herz-Zentrum Bad Krozingen

Bad Krozingen, 79189, Germany

Location

Kerkhoff Klinik

Bad Nauheim, 61231, Germany

Location

Cardiology Praxis Dr. Gekeler

Loerrach, 79540, Germany

Location

Cardiology Praxis Dr. Cron/ Dr. Hess

Basel, 4051, Switzerland

Location

Cardiology Praxis Prof. A. Hoffmann

Basel, 4052, Switzerland

Location

University Hospital of Basel

Basel, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Mitral Valve InsufficiencyHeart Valve Diseases

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Christian Mueller, Prof.

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2007

First Posted

July 31, 2007

Study Start

April 1, 2006

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

February 28, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations