Heart Valve DiseasesSEPNCT02371863
Normal Values in Stress Echocardiographic Parameters in Patients After Successful Mitral Valve Repair for Organic MR
An observational study of Heart Valve Diseases and Mitral Valve Insufficiency, run by UMC Utrecht at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Valve Diseases, Mitral Valve Insufficiency, Heart; Dysfunction Postoperative, Cardiac Surgery
- How many people
- 25 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2014to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age ≥18 years;
- Male or female from all ethnicities;
- At least 6 months post successful, isolated MV repair. S
- Asymptomatic
Who cannot join
- 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;
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Center Utrecht (UMC Utrecht)
Utrecht, Utrecht, 3584 CX
About this study
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
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
- Medical subject headings
- Heart Valve Diseases, Mitral Valve Insufficiency, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Echocardiographic parameter: Peak mitral valve mean gradient (mmHg)
Echocardiographic measured mitral valve mean gradient at peak physical exercise
Measured: at least 6 months after successful MV repair
Echocardiographic parameter: Peak systolic pulmonary artery pressure (sPAP, mmHg)
Echocardiographic measured sPAP at peak physical exercise
Measured: 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.
Measured: at least 6 months after successful MV repair
Secondary outcomes (3)
Echocardiographic parameter: Left ventricular function (LVF, quality description)
Echocardiographic measured LVF quality at rest and peak physical exercise
Measured: at least 6 months after successful MV repair
Echocardiographic parameter: Mitral valve area (MVA, cm2)
Echocardiographic measured MVA at rest and peak physical exercise
Measured: at least 6 months after successful MV repair
Echocardiographic parameter: Peak mitral valve peak gradient (mmHg)
Echocardiographic measured mitral valve peak gradient at peak physical exercise
Measured: at least 6 months after successful MV repair
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startDec 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Valve DiseasesStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, S.A.J. Chamuleau, UMC Utrecht
- Investigators
- Steven AJ Chamuleau, MD, PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02371863
- Sponsor's protocol ID
- NL39865.041.14
- Acronym
- SEP
- Status last verified
- Dec 2015
- First submitted
- 7 Oct 2014
- Last updated
- 29 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29516004
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02371863
- Acronym / sponsor ID
- SEP / NL39865.041.14
- Conditions
- Heart Valve Diseases, Mitral Valve Insufficiency, Heart; Dysfunction Postoperative, Cardiac Surgery, Heart; Disease, Mitral(Valve), Diseases of Mitral Valve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 26 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Age ≥18 years;
- Male or female from all ethnicities;
- At least 6 months post successful, isolated MV repair. S
- Asymptomatic
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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.
3 secondary outcomes
Echocardiographic parameter: Left ventricular function (LVF, quality description)
Time frame: at least 6 months after successful MV repair
Echocardiographic parameter: Mitral valve area (MVA, cm2)
Time frame: at least 6 months after successful MV repair
Echocardiographic parameter: Peak mitral valve peak gradient (mmHg)
Time frame: at least 6 months after successful MV repair
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2015.
- Derived from this study: PubMed 29516004Jansen 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.
Related trials for Heart Valve Diseases
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
RecruitingObservational study
A Post-Market Assessment of the Safety and Performance of the TriClip™ System
Tricuspid Regurgitation (TR)
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven AJ Chamuleau, MD, PhD principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Valve Diseases and Mitral Valve Insufficiency, run by UMC Utrecht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Echocardiographic parameter: Peak mitral valve mean gradient (mmHg) (time frame: at least 6 months after successful MV repair). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02371863, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2015.