Right VEntricular Contractile ReSERVE in Functional Tricuspid Regurgitation (RESERVE)

May 6, 2021 updated by: Philipp Lurz, Heart Center Leipzig - University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

108

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death
Time Frame: 6-12 month
Death according to right ventricular contractile reserve.
6-12 month
Cardiovascular Death
Time Frame: 6-12 month
Cardiovascular Death according to right ventricular contractile reserve.
6-12 month
Heart Failure Hospitalization
Time Frame: 6-12 month
Heart Failure Hospitalization according to right ventricular contractile reserve.
6-12 month
Intrinsic RV contractility
Time Frame: Baseline
Correlation of RV contractile reserve with the slope of invasively derived right ventricular end systolic elastance.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heart Center Leipzig - University Hospital

Investigators

  • Principal Investigator: Philipp Lurz, MD, PhD, University of Leipzig

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2019

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

October 24, 2019

First Submitted That Met QC Criteria

October 25, 2019

First Posted (Actual)

October 28, 2019

Study Record Updates

Last Update Posted (Actual)

May 10, 2021

Last Update Submitted That Met QC Criteria

May 6, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RESERVE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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