Right VEntricular Contractile ReSERVE in Functional Tricuspid Regurgitation
NCT ID: NCT04141683
Last Updated: 2021-05-10
Study Results
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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UNKNOWN
108 participants
OBSERVATIONAL
2019-06-10
2022-12-31
Brief Summary
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Detailed Description
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Aim of the current study is to investigate the prognostic utility of right ventricular contractile reserve in patients with severe TR undergoing surgical or interventional tricuspid valve repair or tricuspid valve replacement.
RV contractile reserve will be assessed using semi-supine bicycle stress echocardiography.
Echocardiographic parameters are prone to altered loading conditions, such as volume overload. Load independent RV contractility can only be measured using invasive pressure-volume-loop (PVL) analysis. Therefore RV PVL analysis will be done using conductance catheter in a subset of patients who undergo right heart catheterization for clinical evaluation of pulmonary hypertension. Aim of this sub study is the validation of non-invasively derived RV contractile reserve with load independent markers of intrinsic RV contractility.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Stress Echocardiography
Dynamic stress echocardiography using a cycle ergometer on a semi supine exercise table.
Pressure volume loop analysis
Pressure volume loop analysis unsing conductance catheter measurements during right heart catheterization.
Tricuspid valve repair or replacement
Tricuspid valve repair or replacement using a surgical or interventionale approach according to local heart team recommendation and patients' preference.
Eligibility Criteria
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Inclusion Criteria
* Planned surgical or interventional tricuspid valve repair or replacement.
* Able to cycle on a semisupine tilting exercise table.
* Informed consent.
Exclusion Criteria
* Unstable Angina.
* Myocardial infarction \<4 month prior to inclusion.
* Concomitant valvular heart disease (aortic, mitral or pulmonary valve) \> mild-moderate.
* Constrictive pericarditis.
* Malignant disease with a life expectancy \< 12 months.
* Pregnancy.
* Insufficient image quality on echocardiography.
18 Years
ALL
No
Sponsors
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Heart Center Leipzig - University Hospital
OTHER
Responsible Party
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Philipp Lurz
Clinical Investigator, Professor, Managing Senior Physician
Principal Investigators
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Philipp Lurz, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Leipzig
Locations
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Heart Center Leipzig at Leipzig University
Leipzig, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RESERVE
Identifier Type: -
Identifier Source: org_study_id
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