Functional Tricuspid RegurgitationRESERVENCT04141683
Right VEntricular Contractile ReSERVE in Functional Tricuspid Regurgitation
An observational study of Functional Tricuspid Regurgitation, run by Heart Center Leipzig - University Hospital at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Tricuspid Regurgitation
- What is being tested?
- Stress Echocardiography, Pressure volume loop analysis and Tricuspid valve repair or replacement
- Type of treatment
- Surgery or procedure
- How many people
- 108 participants
- Where
- 1 siteGermany
- Study dates
- 10 Jun 2019to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients with severe functional tricuspid regurgitation planned for surgical or interventional tricuspid valve repair or replacement.
Who may be able to join
- Severe functional tricuspid regurgitation.
- Planned surgical or interventional tricuspid valve repair or replacement.
- Able to cycle on a semisupine tilting exercise table.
- Informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Heart Center Leipzig at Leipzig University
Leipzig, 04289
Philipp Lurz, MD, PhD, +49341865252022, Philipp.Lurz@medizin.uni-leipzig.de
Maximilian von Roeder, MD, +49341865252517, maximilian.vonroeder@medizin.uni-leipzig.de
About this study
Official title: 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.
Read the 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.
- Conditions
- Functional Tricuspid Regurgitation
- Being tested
- Stress Echocardiography, Pressure volume loop analysis, Tricuspid valve repair or replacement
- Keywords
- tricuspid regurgitation, heart failure, right heart, stress echocardiography, tricuspid repair, tricuspid replacement
- Medical subject headings
- Tricuspid Valve Insufficiency, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress EchocardiographyDiagnostic test
Dynamic stress echocardiography using a cycle ergometer on a semi supine exercise table.
Pressure volume loop analysisDiagnostic test
Pressure volume loop analysis unsing conductance catheter measurements during right heart catheterization.
Tricuspid valve repair or replacementProcedure or surgery
Tricuspid valve repair or replacement using a surgical or interventionale approach according to local heart team recommendation and patients' preference.
What is being measured
The primary outcome is the main question the study is designed to answer.
Death or heart failure hospitalization
Death or heart failure hospitalization according to right ventricular contractile reserve.
Measured: 6-12 month
Secondary outcomes (4)
Death
Death according to right ventricular contractile reserve.
Measured: 6-12 month
Cardiovascular Death
Cardiovascular Death according to right ventricular contractile reserve.
Measured: 6-12 month
Heart Failure Hospitalization
Heart Failure Hospitalization according to right ventricular contractile reserve.
Measured: 6-12 month
Intrinsic RV contractility
Correlation of RV contractile reserve with the slope of invasively derived right ventricular end systolic elastance.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start10 Jun 2019
- Primary completionSep 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Tricuspid RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heart Center Leipzig - University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philipp Lurz, Heart Center Leipzig - University Hospital
- Investigators
- Philipp Lurz, MD, PhD, Principal investigator, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04141683
- Sponsor's protocol ID
- RESERVE
- Acronym
- RESERVE
- Status last verified
- May 2021
- First submitted
- 24 Oct 2019
- Last updated
- 10 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Implication of Right Ventricular Contractile Reserve in Patients With Functional Tricuspid Regurgitation
- ClinicalTrials.gov ID
- NCT04141683
- Acronym / sponsor ID
- RESERVE / RESERVE
- Conditions
- Functional Tricuspid Regurgitation
- Keywords
- tricuspid regurgitation, heart failure, right heart, stress echocardiography, tricuspid repair, tricuspid replacement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Heart Center Leipzig - University HospitalUniversity, hospital or other
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 28 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with severe functional tricuspid regurgitation planned for surgical or interventional tricuspid valve repair or replacement.
Key inclusion criteria (4 listed)
- Severe functional tricuspid regurgitation.
- Planned surgical or interventional tricuspid valve repair or replacement.
- Able to cycle on a semisupine tilting exercise table.
- Informed consent.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress EchocardiographyDynamic stress echocardiography using a cycle ergometer on a semi supine exercise table. | Diagnostic test | – |
| Pressure volume loop analysisPressure volume loop analysis unsing conductance catheter measurements during right heart catheterization. | Diagnostic test | – |
| Tricuspid valve repair or replacementTricuspid valve repair or replacement using a surgical or interventionale approach according to local heart team recommendation and patients' preference. | Procedure or surgery | – |
Primary outcome
Death or heart failure hospitalization
Time frame: 6-12 month
Death or heart failure hospitalization according to right ventricular contractile reserve.
4 secondary outcomes
Death
Time frame: 6-12 month
Cardiovascular Death
Time frame: 6-12 month
Heart Failure Hospitalization
Time frame: 6-12 month
Intrinsic RV contractility
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
- Individual participant dataSharing planned: No
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Comparing the Effects of Newer Pacemakers and Their Effects on the Heart and Valve Function in the Short-term.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philipp Lurz, MD, PhD principal investigator
University of Leipzig
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Tricuspid Regurgitation, run by Heart Center Leipzig - University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philipp Lurz, MD, PhD (+49341865252022, philipp.lurz@medizin.uni-leipzig.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death or heart failure hospitalization (time frame: 6-12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2021.