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

Heart Valve Diseases Clinical Trial

— SEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02371863
• Other study ID #: NL39865.041.14
• Status: Completed
• Phase: N/A
• First received: October 7, 2014
• Last updated: December 27, 2015
• Start date: December 2014
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Netherlands	University Medical Center Utrecht (UMC Utrecht)	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Echocardiographic parameter: Peak systolic pulmonary artery pressure (sPAP, mmHg)	Echocardiographic measured sPAP at peak physical exercise	at least 6 months after successful MV repair	No
Primary	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	No
Secondary	Echocardiographic parameter: Left ventricular function (LVF, quality description)	Echocardiographic measured LVF quality at rest and peak physical exercise	at least 6 months after successful MV repair	No
Secondary	Echocardiographic parameter: Mitral valve area (MVA, cm2)	Echocardiographic measured MVA at rest and peak physical exercise	at least 6 months after successful MV repair	No
Secondary	Echocardiographic parameter: Peak mitral valve peak gradient (mmHg)	Echocardiographic measured mitral valve peak gradient at peak physical exercise	at least 6 months after successful MV repair	No