- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00557934
Right Ventricular Contractility Reserve Following Repair of Tetralogy of Fallot (TOF-Cond)
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Baden-Wuerttemberg
-
Tuebingen, Baden-Wuerttemberg, Germany, 72076
- Department of Pediatric Cardiology, University Childrens Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
dobutamine stress (10 µg/kg/min) for 10 minutes during heart catheterization
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
10 minutes after starting dobutamine infusion
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Brain natriuretic peptide
Time Frame: at cath study
|
at cath study
|
RV enddiastolic volume index (by MRI)
Time Frame: within the last 6 months before study
|
within the last 6 months before study
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael Hofbeck, MD, University Childrens Hospital, Department of Pediatric Cardiology
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Congenital Abnormalities
- Heart Defects, Congenital
- Cardiovascular Abnormalities
- Tetralogy of Fallot
- Ventricular Dysfunction
- Ventricular Dysfunction, Right
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Protective Agents
- Adrenergic Agonists
- Cardiotonic Agents
- Adrenergic beta-Agonists
- Sympathomimetics
- Adrenergic beta-1 Receptor Agonists
- Dobutamine
Other Study ID Numbers
- Cond-07-1
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.
Clinical Trials on Right Ventricular Dysfunction
-
University of ChicagoRecruitingHeart Failure | Right Ventricular Dysfunction | Right Ventricular FailureUnited States
-
Semmelweis University Heart and Vascular CenterCompletedRight Ventricular Dysfunction | Right Heart Failure | Right Ventricular Failure | Mitral Valve DiseaseHungary
-
Centre Hospitalier Universitaire, AmiensRecruitingThoracic Surgery | Right VentricleFrance
-
NHS National Waiting Times Centre BoardNHS Greater Glasgow and Clyde; University of Glasgow; Royal London HospitalNot yet recruitingRight Ventricular DysfunctionUnited Kingdom
-
University of MinnesotaRecruitingRight Ventricular DysfunctionUnited States
-
Montreal Heart InstituteOlivier Lachance, MD; Melissa Parent, MD; Patrick Tawil, MD; Etienne Couture, MD... and other collaboratorsCompletedRight Ventricular Dysfunction | Right Heart Failure | Heart; Dysfunction Postoperative, Cardiac SurgeryCanada
-
Azienda Ospedaliera OO.RR. S. Giovanni di Dio e...RecruitingRight Ventricular DysfunctionItaly
-
University of GiessenGerman Research FoundationUnknownRight Ventricular DysfunctionGermany
-
University Hospital DubravaUnknownRight Ventricular Dysfunction | Left Ventricular Dysfunction | Biventricular FailureCroatia
-
Jewish General HospitalNot yet recruitingRight Ventricular Dysfunction | Left Ventricular Dysfunction | Quality of RecoveryCanada
Clinical Trials on dobutamine
-
University of Sao PauloCompletedCoronary Disease | Cardiac Output, LowBrazil
-
University of Sao Paulo General HospitalUnknownHeart Failure | Cardiogenic Shock
-
Sichuan UniversityNot yet recruitingLaparoscopic HepatectomyChina
-
Medstar Health Research InstituteNational Heart, Lung, and Blood Institute (NHLBI)CompletedHeart Diseases | Cardiovascular Diseases | Heart Failure | Coronary Disease | Heart Failure, Congestive
-
University of AvignonCompletedDiabetes-related ComplicationsFrance
-
University Health Network, TorontoNot yet recruiting
-
Oslo University HospitalCompletedMyocardial Fibrosis | Aortic Valve Stenosis | Left Ventricular DysfunctionNorway
-
Odense University HospitalUniversity of Southern Denmark; Region of Southern DenmarkRecruitingAortic Valve Stenosis | Valvular Heart Disease | Valvular StenosisDenmark
-
University Hospital, GhentCompletedGeneral AnesthesiaBelgium
-
University of CopenhagenCarlsberg GroupCompleted