Right VEntricular Contractile ReSERVE in Functional Tricu... | NCT04141683

Studies
Right VEntricular Contractile ReSERVE in Functional Tricuspid Regurgitation

NCT04141683

Sponsor

Heart Center Leipzig - University Hospital

Status

Unknown status

Last Update Posted

May 10, 2021Actual

Enrollment

108Estimated

Phase

Not provided

Conditions

Functional Tricuspid Regurgitation

Interventions

Stress Echocardiography
Pressure volume loop analysis
Tricuspid valve repair or replacement

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 10, 2019Actual

Primary Completion Date

Sep 2022Estimated

Completion Date

Dec 2022Estimated

First Submitted Date

Oct 24, 2019

First Submission Date that Met QC Criteria

Oct 25, 2019

First Posted Date

Oct 28, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 6, 2021

Last Update Posted Date

May 10, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Philipp Lurz, Clinical Investigator, Professor, Managing Senior Physician, Heart Center Leipzig - University HospitalPrincipal Investigator

Lead Sponsor

Heart Center Leipzig - University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Aim of the study is to investigate the prognostic value of right ventricular contractile reserve in patients with functional tricuspid regurgitation undergoing tricuspid valve repair or replacement.

Detailed Description

Chronic volume overload in patients with severe tricuspid regurgitation (TR) leads to right ventricular (RV) dilatation, fibrosis and eventually failure. RV dysfunction is an important determinant of mortality in patients undergoing tricuspid valve surgery.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

108Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description
Stress Echocardiography	Diagnostic Test	Dynamic stress echocardiography using a cycle ergometer on a semi supine exercise table.
Pressure volume loop analysis	Diagnostic Test	Pressure volume loop analysis unsing conductance catheter measurements during right heart catheterization.
Tricuspid valve repair or replacement	Procedure	Tricuspid valve repair or replacement using a surgical or interventionale approach according to local heart team recommendation and patients' preference.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Death or heart failure hospitalization	Death or heart failure hospitalization according to right ventricular contractile reserve.	6-12 month

Secondary Outcomes

Measure	Description	Time Frame
Death	Death according to right ventricular contractile reserve.	6-12 month
Cardiovascular Death	Cardiovascular Death according to right ventricular contractile reserve.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Severe functional tricuspid regurgitation.
Planned surgical or interventional tricuspid valve repair or replacement.
Able to cycle on a semisupine tilting exercise table.
Informed consent.

Exclusion Criteria:

Coronary artery disease with significant ischemia.
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Consecutive patients with severe functional tricuspid regurgitation planned for surgical or interventional tricuspid valve repair or replacement.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Philipp Lurz, MD, PhD	Contact	+49341865252022		philipp.lurz@medizin.uni-leipzig.de
Maximilian von Roeder, MD	Contact	+49341865252517		maximilian.vonroeder@medizin.uni-leipzig.de

Overall Officials

Name	Affiliation	Role
Philipp Lurz, MD, PhD	University of Leipzig	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Heart Center Leipzig at Leipzig University	Recruiting	Leipzig		04289	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014262	Tricuspid Valve Insufficiency
D006333	Heart Failure

Ancestor Terms

ID	Term
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D025401	Echocardiography, Stress
D012092	Replantation

Ancestor Terms

ID	Term
D004452	Echocardiography
D057791	Cardiac Imaging Techniques
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided