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

NCT02371863 | Completed

• 1 other identifier: NL39865.041.14
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Valve Diseases; Mitral Valve Insufficiency; Heart; Dysfunction Postoperative, Cardiac Surgery; Heart; Disease, Mitral(Valve); Diseases of Mitral Valve

Outcome Measures

Primary Outcomes (3)

• Echocardiographic parameter: Peak mitral valve mean gradient (mmHg)

  Echocardiographic measured mitral valve mean gradient at peak physical exercise

  at least 6 months after successful MV repair

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

  Echocardiographic measured sPAP at peak physical exercise

  at least 6 months after successful MV repair

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

  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.

  at least 6 months after successful MV repair

Secondary Outcomes (3)

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

  at least 6 months after successful MV repair

• Echocardiographic parameter: Mitral valve area (MVA, cm2)

  at least 6 months after successful MV repair

• Echocardiographic parameter: Peak mitral valve peak gradient (mmHg)

  at least 6 months after successful MV repair

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

25 Asymptomatic patients (≥18 years) at least 6 months after successful MV repair. Patients will have a LVEF ≥45%, and were initially operated based on organic MV regurgitation.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (1)

University Medical Center Utrecht (UMC Utrecht)

Utrecht, Utrecht, 3584 CX, Netherlands

Location

Related Publications (1)

• Jansen R, Urgel K, Cramer MJ, van Aarnhem EEHL, Zwetsloot PPM, Doevendans PA, Kluin J, Chamuleau SAJ. Reference Values for Physical Stress Echocardiography in Asymptomatic Patients after Mitral Valve Repair. Front Surg. 2018 Feb 19;5:6. doi: 10.3389/fsurg.2018.00006. eCollection 2018.

  PMID: 29516004 DERIVED

MeSH Terms

Conditions

Heart Valve Diseases; Mitral Valve Insufficiency; Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Steven AJ Chamuleau, MD, PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: October 7, 2014
• First Posted: February 26, 2015
• Study Start: December 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 29, 2015

Record last verified: 2015-12

Locations

NL (1)