Cardiac Function Under Stress for Early Detection of the Right Ventricular Insufficiency After Repair of Tetralogy of Fallot

NCT00564993 | Terminated Phase 3

• 2 other identifiers: MP 4.3 Fallot-stressEudraCT number: 2007-003461-41
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 11

Brief Summary

Summary: The investigators aim to identify markers of right ventricular dysfunction in patients with severe pulmonary regurgitation following repair of Tetralogy of Fallot, that allow prediction of the optimal timing of the replacement of the regurgitant valve. The investigators will use MR as a gold-standard reference for measurement of cardiac function during rest and dobutamine stress. The investigators will also evaluate the predictive potential of tissue Doppler imaging in this patient group. Purpose: To predict the optimum timing of pulmonary valve replacement for severe regurgitation in repaired Tetralogy of Fallot using Cardiac Magnetic resonance with dobutamine stress testing.

Conditions

Tetralogy of Fallot

Outcome Measures

Primary Outcomes (1)

• Identification of predictive parameters of right ventricular insufficiency

  1 year

Secondary Outcomes (1)

• Evaluation of mortality, morbidity, pulmonary function, objective exercise tolerance, life-quality and prevalence of cardiac arrhythmia after pulmonary valve replacement

  1 year

Study Arms (2)

A

ACTIVE COMPARATOR

necessary re-intervention (pulmonary valve replacement) after repair of Fallot: 2 Visits with cardiac imaging under rest and stress (Dobutamin) before and after pulmonary valve replacement

Drug: Dobutamin

B

ACTIVE COMPARATOR

comparison group: with a good result of repair of tetralogy of fallot and good ventricular function: 1 Visit with cardiac imaging under rest and stress (Dobutamin)

Drug: Dobutamin

Interventions

Dobutamin DRUG

10\&20 µg/kg/min

A; B

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent of the patient or patient's legal representatives
• No participation in another AMG driven study within the past 4 weeks or during the whole duration of this study
• Patients with Tetralogy of Fallot after corrective surgery
• group A (n=45): Adolescents ≥ 14 years or adults with Tetralogy of Fallot after corrective surgery and necessary re-intervention (pulmonary valve replacement because of pulmonary insufficiency
• group B (n=35): Adolescents ≥ 14 years or adults with Tetralogy of Fallot after corrective surgery and good result of repair and good right ventricular function

You may not qualify if:

• Non-specific
• pregnancy or lactation
• women of child-bearing age who are sexually active without practising highly effective methods of contraception (a urine/serum pregnancy test may be requested at the discretion of the investigator)
• any diseases or impairment that, in the opinion of the investigator, would justify to exclude a subject from participation
• substance abuse (alcohol, medicines, drugs)
• other medical, psychological or social circumstances that would adversely affect a patient's ability to participate reliably in the study or increase the risk to themselves or others if they participated
• insufficient compliance
• disagreement with storage \& transfer of anonymized disease data within this study.
• Persons who are detained officially or legally to an official institution
• Specific
• contraindication against pharmacological stress testing (ventricular tachycardia or severe arrhythmia, profound pulmonary stenosis and hypertension of the pulmonary artery)
• coronary heart disease
• atrial fibrillation or flutter
• DORV (if there is another VSD than subaortic)
• associated severe heart defects

Sponsors & Collaborators

• Competence Network for Congenital Heart Defects: lead
• German Federal Ministry of Education and Research: collaborator

Study Sites (11)

Universitätsklinikum Freiburg, Klinik III Päd. Kardiologie

Freiburg im Breisgau, Baden-Wurttemberg, D-79106, Germany

Location

Universitätsklinikum Tübingen, Klinik für Kinderheilkunde und Jugendmedizin

Tübingen, Baden-Wurttemberg, D-72076, Germany

Location

Deutsches Herzzentrum München

Munich, Bavaria, D-80336, Germany

Location

Medizinische Hochschule Hannover, Pädiatrische Kardiologie und Intensivmedizin

Hanover, Lower Saxony, D-30625, Germany

Location

Herz-und Diabeteszentrum Nordrhein-Westfalen

Bad Oeynhausen, North Rhine-Westphalia, D-32545, Germany

Location

Universitätsklinikum Münster, Klinik und Poliklinik für Kinder- und Jugendmedizin, Pädiatrische Kardiologie

Münster, North Rhine-Westphalia, D-48149, Germany

Location

Deutsches Kinderherzzentrum St. Augustin

Sankt Augustin, North Rhine-Westphalia, D-53757, Germany

Location

Universitätsklinikum des Saarlandes

Homburg/Saar, Saarland, D-66421, Germany

Location

Herzzentrum Leipzig, Klinik für Kinderkardiologie

Leipzig, Saxony, D-04289, Germany

Location

Universitätsklinikum Schleswig-Holstein Campus Kiel

Kiel, Schleswig-Holstein, D-24105, Germany

Location

Deutsches Herzzentrum Berlin

Berlin, State of Berlin, D-13353, Germany

Location

Related Links

• Competence Network for Congenital Heart Defects

MeSH Terms

Conditions

Tetralogy of Fallot

Interventions

Dobutamine

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Catecholamines; Amines; Organic Chemicals; Phenethylamines; Ethylamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Philipp Beerbaum, MD

  Evelina Children's Hospital, Guy's and St. Thomas Foundation Trust, Interdisciplinary Medical Imaging Group, King's College London

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: November 28, 2007
• First Posted: November 29, 2007
• Study Start: November 1, 2007
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2012
• Last Updated: June 6, 2012

Record last verified: 2011-08

Locations

DE (11)