Tricuspid Valve InsufficiencyNCT01444222
Behaviour of Tricuspid Valve Regurgitation in Volume and/or Pressure Loaded Right Heart
An observational study of Tricuspid Valve Insufficiency, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Right-sided heart disease has an important impact on the prognosis of patients with valvular heart disease. Up to now, Tricuspid Valve Regurgitation (TR) and right heart hemodynamics have not been extensively investigated. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tricuspid Valve Insufficiency
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 18 Oct 2011to 31 Jan 2014
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: * Pulmonary Arterial Hypertension * Pulmonic Valve Stenosis * Pulmonic valve insufficiency * Atrium Septum Defect * Ebstein's Anomaly * Transvalvular RV pacemaker/ shock lead * Control
Who may be able to join
- Pulmonary Arterial Hypertension
- Pulmonic Valve Stenosis
- Pulmonic valve homograft
- Pulmonic valve insufficiency
- Atrium Septum Defect
- Ebstein's Anomaly
- Transvalvular RV pacemaker/ shock lead
- Control
Who cannot join
- age < 16 years
- not fit for bicycle testing
Trial locations and contacts
1 site in 1 country.
About this study
Right-sided heart disease has an important impact on the prognosis of patients with valvular heart disease. Up to now, Tricuspid Valve Regurgitation (TR) and right heart hemodynamics have not been extensively investigated. However, it is plausible that a significant degree of TR and the associated volume-overload of the right ventricle cause significant right ventricular wall stress. Although minor TR generally is well tolerated, major TR can lead to clinical symptoms, right ventricular dilatation and ultimately right ventricular heart failure. Up to now, the investigators do not dispose of any tools to diagnose and anticipate this unfavourable evolution. Nevertheless it is likely that right ventricular failure is preceded with a subclinical dysfunction of the right ventricle and a possibly reversible change in contractility of the myocardium.
Recently, new techniques to evaluate the systolic function, the contractility and the hemodynamics of the heart have become available.
Read more
First, this study will help us assessing the feasibility and accuracy of several imaging modalities in right-sided heart pathology with focus on TR and right heart myocardial performance.
Second, this study will contribute to a better understanding of the hemodynamic effect of volume-overload and/or pressure-overload of the right ventricle. It will clarify the behaviour of TR, the evolution of right ventricular myocardial contractility and dysfunction during exercise and its impact on exercise capacity. By doing this, discrimination between well tolerated and ill-tolerated TR will be possible, thus identifying patients who might be eligible for treatment (medical, corrective, …).
- Conditions
- Tricuspid Valve Insufficiency
- Keywords
- Myocardial contractility, Quantification of regurgitant flow, exercise capacity
- Medical subject headings
- Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Hypertension | Not described | |
| pulmonic valve stenosis | Not described | |
| pulmonic valve homograft | Not described | |
| pulmonic valve insufficiency | Not described | |
| atrial septum defect | Not described | |
| Ebstein's anomaly | Not described | |
| transvalvular right ventricular lead | Not described | |
| control | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2011 (estimated)
- Study start18 Oct 2011
- Primary completion24 May 2013
- Study completion31 Jan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tricuspid Valve InsufficiencyStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Werner Budts, MD, PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01444222
- Sponsor's protocol ID
- s53471
- Status last verified
- Jan 2011
- First submitted
- 27 Sep 2011
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
De Meester P, Buys R, Van De Bruaene A, Gabriels C, Voigt JU, Vanhees L, Herijgers P, Troost E, Budts W. Functional and haemodynamic assessment of mild-to-moderate pulmonary valve stenosis at rest and during exercise. Heart. 2014 Sep;100(17):1354-9. doi: 10.1136/heartjnl-2014-305627. Epub 2014 Apr 29.
PubMed 24780907
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behaviour of Tricuspid Valve Regurgitation in Volume and/or Pressure Loaded Right Heart
- ClinicalTrials.gov ID
- NCT01444222
- Acronym / sponsor ID
- s53471
- Conditions
- Tricuspid Valve Insufficiency
- Keywords
- Myocardial contractility, Quantification of regurgitant flow, exercise capacity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 18 Oct 2011 (actual)
- Primary completion
- 24 May 2013 (actual)
- Study completion
- 31 Jan 2014 (actual)
- First posted
- 30 Sep 2011 (estimated)
- 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.
Right-sided heart disease has an important impact on the prognosis of patients with valvular heart disease. Up to now, Tricuspid Valve Regurgitation (TR) and right heart hemodynamics have not been extensively investigated. However, it is plausible that a significant degree of TR and the associated volume-overload of the right ventricle cause significant right ventricular wall stress. Although minor TR generally is well tolerated, major TR can lead to clinical symptoms, right ventricular dilatation and ultimately right ventricular heart failure. Up to now, the investigators do not dispose of any tools to diagnose and anticipate this unfavourable evolution. Nevertheless it is likely that right ventricular failure is preceded with a subclinical dysfunction of the right ventricle and a possibly reversible change in contractility of the myocardium.
Recently, new techniques to evaluate the systolic function, the contractility and the hemodynamics of the heart have become available.
First, this study will help us assessing the feasibility and accuracy of several imaging modalities in right-sided heart pathology with focus on TR and right heart myocardial performance.
Second, this study will contribute to a better understanding of the hemodynamic effect of volume-overload and/or pressure-overload of the right ventricle. It will clarify the behaviour of TR, the evolution of right ventricular myocardial contractility and dysfunction during exercise and its impact on exercise capacity. By doing this, discrimination between well tolerated and ill-tolerated TR will be possible, thus identifying patients who might be eligible for treatment (medical, corrective, …).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Hypertension | – | – |
| pulmonic valve stenosis | – | – |
| pulmonic valve homograft | – | – |
| pulmonic valve insufficiency | – | – |
| atrial septum defect | – | – |
| Ebstein's anomaly | – | – |
| transvalvular right ventricular lead | – | – |
| control | – | – |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- * Pulmonary Arterial Hypertension * Pulmonic Valve Stenosis * Pulmonic valve insufficiency * Atrium Septum Defect * Ebstein's Anomaly * Transvalvular RV pacemaker/ shock lead * Control
Key inclusion criteria (8 listed)
- Pulmonary Arterial Hypertension
- Pulmonic Valve Stenosis
- Pulmonic valve homograft
- Pulmonic valve insufficiency
- Atrium Septum Defect
Key exclusion criteria (2 listed)
- age < 16 years
- not fit for bicycle testing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Derived from this study: PubMed 24780907De Meester P, Buys R, Van De Bruaene A, Gabriels C, Voigt JU, Vanhees L, Herijgers P, Troost E, Budts W. Functional and haemodynamic assessment of mild-to-moderate pulmonary valve stenosis at rest and during exercise. Heart. 2014 Sep;100(17):1354-9. doi: 10.1136/heartjnl-2014-305627. Epub 2014 Apr 29.
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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.
Werner Budts, MD, PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
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 Tricuspid Valve Insufficiency, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 8 inclusion and 2 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: finished, as of the sponsor's last update on 26 Jan 2023. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01444222, which also lists 1 linked publication.
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 26 Jan 2023.