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Completed

NCT Number: NCT02371863

Normal Values in Stress Echocardiographic Parameters in Patients After Successful Mitral Valve Repair for Organic MR

Surgical treatment is the only approach with potentially defined clinical success for organic mitral valve (MV) regurgitation. Recurrent or persistent complaints after initial successful MV repair is a clinical challenge in current practice. Especially when echo parameters at rest are within or near normal ranges and patients presenting disproportionately symptomatic in relation to the observed results. However, while MV regurgitation is a hemodynamic disease, currently used 2-dimensional (2D) transthoracic echocardiography (TTE) at rest lacks information about hemodynamic changes. Physical stress echocardiography is a promising technique to complement nowadays rest TTE in order to improve interpretation of hemodynamic changes. However, normal values for exercise echo are lacking in this postoperative patients cohort. A prospective, observational trial to determine normal values in stress echocardiographic parameters in asymptomatic patients after successful MV repair for organic MV regurgitation, is therefore highly needed.

Purpose of the SEP- study is to determine normal values in stress echocardiographic parameters in asymptomatic patients at least 6 months after successful MV repair for organic MV regurgitation. These normal values for stress echo are of utmost importance to correctly and accurate interpret stress echo results during postoperative follow-up and to improve clinical decision making in patients post MV repair.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Utrecht (UMC Utrecht)

Utrecht, 3584 CX, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years;
  • Male or female from all ethnicities;
  • At least 6 months post successful, isolated MV repair. S
  • Asymptomatic

Exclusion criteria

  • Pulmonary hypertension >50 mmHg at rest;
  • Atrial fibrillation (AF) at time of study related stress echo test;
  • Known contraindication or incapability to perform peak exercise or inability to perform physical stress testing;
  • LVEF <45%;
  • NYHA class II and more.
  • Other heart valve disease of more than mild severity;
  • Concomitant surgery during MV repair, e.g. MAZE, TVP procedure;
  • Prior heart valve surgery;
  • Congenital heart disease;
  • Disabling comorbidity, e.g. chronic obstructive pulmonary disease (COPD);
  • Unable to provide informed consent

Treatment and study plan

Primary outcomes

  1. Echocardiographic parameter: Peak mitral valve mean gradient (mmHg)

    Time frame: at least 6 months after successful MV repair

    Echocardiographic measured mitral valve mean gradient at peak physical exercise

  2. Echocardiographic parameter: Peak systolic pulmonary artery pressure (sPAP, mmHg)

    Time frame: at least 6 months after successful MV repair

    Echocardiographic measured sPAP at peak physical exercise

  3. Echocardiographic parameter: Increase in mitral valve regurgitation grade (grade 0-4, according to ESC guidelines)

    Time frame: at least 6 months after successful MV repair

    Echocardiographic measured increase in mitral valve regurgitation at peak physical exercise during physical stress echo, compared to rest echo. Grading of mitral regurgitation will be performed according to the ESC guidelines.

Secondary outcomes

  1. Echocardiographic parameter: Left ventricular function (LVF, quality description)

    Time frame: at least 6 months after successful MV repair

    Echocardiographic measured LVF quality at rest and peak physical exercise

  2. Echocardiographic parameter: Mitral valve area (MVA, cm2)

    Time frame: at least 6 months after successful MV repair

    Echocardiographic measured MVA at rest and peak physical exercise

  3. Echocardiographic parameter: Peak mitral valve peak gradient (mmHg)

    Time frame: at least 6 months after successful MV repair

    Echocardiographic measured mitral valve peak gradient at peak physical exercise

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Registry information

Official study title

SEP-study; The Assessment of Normal Values in Stress Echocardiographic Parameters in Patients After Successful Mitral Valve Repair for Organic Mitral Valve Regurgitation

Acronym: SEP

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 26, 2015
Registry last updated
Dec 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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