Right VEntricular Contractile ReSERVE in Functional Tricuspid Regurgitation
RESERVE
Prognostic Implication of Right Ventricular Contractile Reserve in Patients With Functional Tricuspid Regurgitation
1 other identifier
observational
108
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 10, 2019
CompletedFirst Submitted
Initial submission to the registry
October 24, 2019
CompletedFirst Posted
Study publicly available on registry
October 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedMay 10, 2021
May 1, 2021
3.2 years
October 24, 2019
May 6, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Death or heart failure hospitalization
Death or heart failure hospitalization according to right ventricular contractile reserve.
6-12 month
Secondary Outcomes (4)
Death
6-12 month
Cardiovascular Death
6-12 month
Heart Failure Hospitalization
6-12 month
Intrinsic RV contractility
Baseline
Interventions
Dynamic stress echocardiography using a cycle ergometer on a semi supine exercise table.
Pressure volume loop analysis unsing conductance catheter measurements during right heart catheterization.
Tricuspid valve repair or replacement using a surgical or interventionale approach according to local heart team recommendation and patients' preference.
Eligibility Criteria
Consecutive patients with severe functional tricuspid regurgitation planned for surgical or interventional tricuspid valve repair or replacement.
You may qualify if:
- Severe functional tricuspid regurgitation.
- Planned surgical or interventional tricuspid valve repair or replacement.
- Able to cycle on a semisupine tilting exercise table.
- Informed consent.
You may not qualify if:
- Coronary artery disease with significant ischemia.
- Unstable Angina.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Heart Center Leipzig at Leipzig University
Leipzig, 04289, Germany
Biospecimen
Blood serum, whole blood
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philipp Lurz, MD, PhD
University of Leipzig
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Investigator, Professor, Managing Senior Physician
Study Record Dates
First Submitted
October 24, 2019
First Posted
October 28, 2019
Study Start
June 10, 2019
Primary Completion
September 1, 2022
Study Completion
December 1, 2022
Last Updated
May 10, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share