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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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S.A.J. Chamuleau

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Steven AJ Chamuleau, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht

Locations

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University Medical Center Utrecht (UMC Utrecht)

Utrecht, Utrecht, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED

PMID: 29516004 (View on PubMed)

Other Identifiers

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NL39865.041.14

Identifier Type: -

Identifier Source: org_study_id