Right Ventricular DysfunctionTOF-CondNCT00557934
Right Ventricular Contractility Reserve Following Repair of Tetralogy of Fallot
A study testing dobutamine in people with Right Ventricular Dysfunction, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Background: Residual pulmonary regurgitation following repair of tetralogy of Fallot, in particular the use of a transannular patch, has been shown to correlate with the development of right ventricular dysfunction. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Right Ventricular Dysfunction
- What is being tested?
- dobutamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2007to Sep 2008
- Phase
- Interventional
- 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 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Corrected tetralogy of Fallot or other surgery with involvement of the pulmonary valve, chronic pulmonary regurgitation, dilated right ventricle
- Patient's age > 4 years
- Routine cardiac catheterization clinically indicated for deciding therapeutic treatment
- Informed assent/consent of patients/parent.
Who cannot join
- Pregnancy/breast feeding, women of child-bearing age without contraception.
- Present participation, and/or participation in a clinical study during the last 4 weeks.
- Illnesses or malfunctions, which exclude a participation in this study after decision of the investigating physician.
- Other medical, psychological or social circumstances which complicate a regular participation in the study, and/or increase the risk for the patients themselves.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Pediatric Cardiology, University Childrens Hospital
Tübingen, Baden-Wurttemberg, 72076
About this study
Official title: Evaluation of Right Ventricular Contractility Reserve Function During Dobutamine Stress in Patients Following Surgical Repair of Tetralogy of Fallot
Background: Residual pulmonary regurgitation following repair of tetralogy of Fallot, in particular the use of a transannular patch, has been shown to correlate with the development of right ventricular dysfunction. Optimal timing of pulmonary valve replacement, therefore, is important to preserve right ventricular function. Several recent studies suggested that a threshold of right ventricular end-diastolic volume for intervention, in order to preserve the likelihood of adequate reverse remodeling, is in the region of 150 to 200 ml/m2 body surface area. However, there is evidence that right ventricular function does not always recover following pulmonary valve replacement even if the end-diastolic volume is below this cut-off.
In addition, previous studies suggested that early dysfunction may be present before symptoms occur. However, early dysfunction is difficult to assess.
Read more
Methods: Analysis of right ventricular function by pressure-volume loops has been extensively evaluated in experimental studies and is generally considered the optimal way to quantify right ventricular function.
By recording a family of pressure-volume loops during reduction of preload, achieved by temporary balloon occlusion of the inferior caval vein, the contractility can be calculated by the slope of the endsystolic pressure-volume relation (elastance). Changes of contractility following dobutamine infusion could be noted by changes of elastance. The increase of the slope during dobutamine demonstrates the contractility reserve of the right ventricle.
Purpose: To evaluate the right ventricular contractility reserve to determine early ventricular dysfunction after repair of tetralogy of Fallot.
- Conditions
- Right Ventricular Dysfunction
- Being tested
- dobutamine
- Keywords
- tetralogy of Fallot, right ventricular dysfunction, pulmonary insufficiency, pulmonary valve replacement, pressure-volume loops, long-term follow-up in tetralogy of Fallot
- Medical subject headings
- Ventricular Dysfunction, Right, Tetralogy of Fallot, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dobutamineOther
dobutamine stress (10 µg/kg/min) for 10 minutes during heart catheterization
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Other: dobutamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of change of the maximal elastance (slope of the endsystolic pressure-volume relation)of the right ventricle following dobutamine infusion
Measured: 10 minutes after starting dobutamine infusion
Secondary outcomes (2)
Brain natriuretic peptide
Measured: at cath study
RV enddiastolic volume index (by MRI)
Measured: within the last 6 months before study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2007 (estimated)
- Study startOct 2007
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Right Ventricular DysfunctionStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Fördergemeinschaft Deutsche Kinderherzzentren, Bonn, Germany
- Investigators
- Michael Hofbeck, MD, Principal investigator, University Childrens Hospital, Department of Pediatric Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00557934
- Sponsor's protocol ID
- Cond-07-1
- Acronym
- TOF-Cond
- Status last verified
- Sep 2008
- First submitted
- 13 Nov 2007
- Last updated
- 19 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Right Ventricular Contractility Reserve Function During Dobutamine Stress in Patients Following Surgical Repair of Tetralogy of Fallot
- ClinicalTrials.gov ID
- NCT00557934
- Acronym / sponsor ID
- TOF-Cond / Cond-07-1
- Conditions
- Right Ventricular Dysfunction
- Keywords
- tetralogy of Fallot, right ventricular dysfunction, pulmonary insufficiency, pulmonary valve replacement, pressure-volume loops, long-term follow-up in tetralogy of Fallot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Fördergemeinschaft Deutsche Kinderherzzentren, Bonn, Germany
- Study start
- Oct 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 14 Nov 2007 (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.
Background: Residual pulmonary regurgitation following repair of tetralogy of Fallot, in particular the use of a transannular patch, has been shown to correlate with the development of right ventricular dysfunction. Optimal timing of pulmonary valve replacement, therefore, is important to preserve right ventricular function. Several recent studies suggested that a threshold of right ventricular end-diastolic volume for intervention, in order to preserve the likelihood of adequate reverse remodeling, is in the region of 150 to 200 ml/m2 body surface area. However, there is evidence that right ventricular function does not always recover following pulmonary valve replacement even if the end-diastolic volume is below this cut-off.
In addition, previous studies suggested that early dysfunction may be present before symptoms occur. However, early dysfunction is difficult to assess.
Methods: Analysis of right ventricular function by pressure-volume loops has been extensively evaluated in experimental studies and is generally considered the optimal way to quantify right ventricular function.
By recording a family of pressure-volume loops during reduction of preload, achieved by temporary balloon occlusion of the inferior caval vein, the contractility can be calculated by the slope of the endsystolic pressure-volume relation (elastance). Changes of contractility following dobutamine infusion could be noted by changes of elastance. The increase of the slope during dobutamine demonstrates the contractility reserve of the right ventricle.
Purpose: To evaluate the right ventricular contractility reserve to determine early ventricular dysfunction after repair of tetralogy of Fallot.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: dobutamine |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Corrected tetralogy of Fallot or other surgery with involvement of the pulmonary valve, chronic pulmonary regurgitation, dilated right ventricle
- Patient's age > 4 years
- Routine cardiac catheterization clinically indicated for deciding therapeutic treatment
- Informed assent/consent of patients/parent.
Key exclusion criteria (4 listed)
- Pregnancy/breast feeding, women of child-bearing age without contraception.
- Present participation, and/or participation in a clinical study during the last 4 weeks.
- Illnesses or malfunctions, which exclude a participation in this study after decision of the investigating physician.
- Other medical, psychological or social circumstances which complicate a regular participation in the study, and/or increase the risk for the patients themselves.
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 |
|---|---|---|
| dobutaminedobutamine stress (10 µg/kg/min) for 10 minutes during heart catheterization | Other | 1 |
Primary outcome
Percentage of change of the maximal elastance (slope of the endsystolic pressure-volume relation)of the right ventricle following dobutamine infusion
Time frame: 10 minutes after starting dobutamine infusion
2 secondary outcomes
Brain natriuretic peptide
Time frame: at cath study
RV enddiastolic volume index (by MRI)
Time frame: within the last 6 months before study
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 19 Sep 2008.
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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.
Michael Hofbeck, MD principal investigator
University Childrens Hospital, Department of Pediatric Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dobutamine in people with Right Ventricular Dysfunction, run by University Hospital Tuebingen 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 4 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 19 Sep 2008. 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?
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.
What does the primary outcome measure?
Percentage of change of the maximal elastance (slope of the endsystolic pressure-volume relation)of the right ventricle following dobutamine infusion (time frame: 10 minutes after starting dobutamine infusion). 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 19 Sep 2008.