Clinical trial NCT04141683: Right VEntricular Contractile ReSERVE in Functional Tricuspid Regurgitation
Official title: Prognostic Implication of Right Ventricular Contractile Reserve in Patients With Functional Tricuspid Regurgitation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Functional Tricuspid Regurgitation
Keywords: tricuspid regurgitation
heart failure
right heart
stress echocardiography
tricuspid repair
tricuspid replacement
Lead sponsor: Heart Center Leipzig - University Hospital
Sponsor class: OTHER
First posted: 2019-10-28
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients with severe functional tricuspid regurgitation planned for surgical or interventional tricuspid valve repair or replacement.

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.

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.

Primary outcomes:
measure: Death or heart failure hospitalization
timeFrame: 6-12 month
Secondary outcomes:
measure: Death
timeFrame: 6-12 month
measure: Cardiovascular Death
timeFrame: 6-12 month
measure: Heart Failure Hospitalization
timeFrame: 6-12 month
measure: Intrinsic RV contractility
timeFrame: Baseline
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Heart Center Leipzig at Leipzig University
Study officials:
affiliation: University of Leipzig
name: Philipp Lurz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: