Right VEntricular Contractile ReSERVE in Functional Tricuspid Regurgitation

Functional Tricuspid Regurgitation Clinical Trial

— RESERVE  

Official title:

Prognostic Implication of Right Ventricular Contractile Reserve in Patients With Functional Tricuspid Regurgitation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04141683
• Other study ID #: RESERVE
• Status: Recruiting
• Start date: June 10, 2019
• Est. completion date: December 2022

Study information

• Verified date: May 2021
• Source: Heart Center Leipzig - University Hospital
• Contact: Philipp Lurz, MD, PhD
• Phone: +49341865252022
• Email: philipp.lurz[@]medizin.uni-leipzig.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: December 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Functional Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

Intervention

Diagnostic Test:
• 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.

Procedure:
• 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.

Locations

Country	Name	City	State
Germany	Heart Center Leipzig at Leipzig University	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
Heart Center Leipzig - University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death or heart failure hospitalization	Death or heart failure hospitalization according to right ventricular contractile reserve.	6-12 month
Secondary	Death	Death according to right ventricular contractile reserve.	6-12 month
Secondary	Cardiovascular Death	Cardiovascular Death according to right ventricular contractile reserve.	6-12 month
Secondary	Heart Failure Hospitalization	Heart Failure Hospitalization according to right ventricular contractile reserve.	6-12 month
Secondary	Intrinsic RV contractility	Correlation of RV contractile reserve with the slope of invasively derived right ventricular end systolic elastance.	Baseline