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

Sponsors and Collaborators:	Competence Network for Congenital Heart Defects German Federal Ministry of Education and Research
Information provided by:	Competence Network for Congenital Heart Defects
ClinicalTrials.gov Identifier:	NCT00564993

Purpose

Summary:

We 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. We will use MR as a gold-standard reference for measurement of cardiac function during rest and dobutamine stress. We 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.

Condition	Intervention	Phase
Tetralogy of Fallot	Drug: Dobutamin	Phase III

MedlinePlus related topics: Exercise and Physical Fitness

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Cardiac Imaging Under Exercise Stress Test for Early Assessment of Right Ventricular Function in Patients With Tetralogy of Fallot and Pulmonary Regurgitation

Further study details as provided by Competence Network for Congenital Heart Defects:

Primary Outcome Measures:

Identification of predictive parameters of right ventricular insufficiency [ Time Frame: 1 year ]

Secondary Outcome Measures:

Evaluation of mortality, morbidity, pulmonary function, objective exercise tolerance, life-quality and prevalence of cardiac arrhythmia after pulmonary valve replacement [ Time Frame: 1 year ]

Estimated Enrollment:	80
Study Start Date:	November 2007
Estimated Study Completion Date:	October 2010

Arms	Assigned Interventions
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 10&20 µg/kg/min
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 10&20 µg/kg/min

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Eligibility

Ages Eligible for Study:	14 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
associated other severe (=hemodynamic significantly) valvular defects except for pulmonary insufficiency
Other clinically relevant diseases, such as malignant tumour or florid diseases (as considered by the investigating physician)
MRI contraindication, e.g. cardiac pacemaker, implanted neurostimulators and other magnetisable foreign bodies
Patient is not able to perform spiroergometry (bicycle/treadmill) or existing contraindications
Patients with Type I or II diabetes
prohibited concomitant medication: MAO-inhibitors
Treatment with beta- or alpha-blocker
Treatment with high doses of ACE-inhibitors or inhibitors of the AT- receptor and permanent treatment with nitrates (in the investigating physician's risk assessment)
Anticoagulation treatment (risk-benefit decision by the investigating physician, as there may be additional inhibition of platelet aggregation with dobutamine)
Treatment with diuretics (risk-benefit decision by the investigating physician, as there may be enhancement of the hypokalemia by administration of dobutamine); if necessary verification of the serum K+ -level before exposure to dobutamine
all contraindications against the study medication described in the SMPC

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00564993

Contacts

Contact: Samir Sarikouch, MD

49 511-532-5567

sarikouch.samir@mh-hannover.de

Locations

Germany
Deutsches Herzzentrum Berlin	Recruiting
Berlin, Germany, D-13353
Contact: Prof. Titus Kühne, MD +49 30-4593-2800 kuehne@dhzb.de
Principal Investigator: Prof. T. Kühne, MD
Sub-Investigator: J. Riesenkampff, MD
Sub-Investigator: G. Heise, MD
Sub-Investigator: M. Yegitbasi, MD
Germany, Baden-Wuerttemberg
Universitätsklinikum Tübingen, Klinik für Kinderheilkunde und Jugendmedizin	Recruiting
Tübingen, Baden-Wuerttemberg, Germany, D-72076
Contact: M. Hofbeck, Prof. +49 7071-298-7147 michael.hofbeck@med.uni-tuebingen.de
Principal Investigator: M. Hofbeck, Prof.
Sub-Investigator: C. Apitz, MD
Sub-Investigator: L. Sieverding, Prof.
Germany, Bavaria
Deutsches Herzzentrum München	Recruiting
Munich, Bavaria, Germany, D-80336
Contact: John Hess, Prof. +49 89 12 18 3010 hess@dhm.mhn.de
Principal Investigator: J. Hess, Prof.
Sub-Investigator: A. Hager, MD
Germany, Lower Saxony
Medizinische Hochschule Hannover, Pädiatrische Kardiologie und Intensivmedizin	Recruiting
Hannover, Lower Saxony, Germany, D-30625
Contact: Friederike Danne, MD +49 511-532 3220 friederike.danne@berlin.de
Principal Investigator: F. Danne, MD
Sub-Investigator: B. Wermter, MD
Sub-Investigator: M. Sasse, MD
Sub-Investigator: S. Sarikouch, MD
Germany, North Rhine-Westphalia
Deutsches Kinderherzzentrum St. Augustin	Recruiting
Sankt Augustin, North Rhine-Westphalia, Germany, D-53757
Contact: Michael Kaestner, MD +49 2241-249-655 m.kaestner@asklepios.com
Principal Investigator: M. Kaestner, MD
Sub-Investigator: N. Toussaint-Götz, MD
Herz-und Diabeteszentrum Nordrhein-Westfalen	Recruiting
Bad Oeynhausen, North Rhine-Westphalia, Germany, D-32545
Contact: Rainer Schäffler, MD +49 5731- 97 3628 rschaeffler@hdz-nrw.de
Principal Investigator: R. Schäffler, MD
Sub-Investigator: N. Haas, MD
Sub-Investigator: K. T. Laser, MD
Universitätsklinikum Münster, Klinik und Poliklinik für Kinder- und Jugendmedizin, Pädiatrische Kardiologie	Recruiting
Münster, North Rhine-Westphalia, Germany, D-48149
Contact: Hans Gerd Kehl, MD +49 251-834 7796 kehl@uni-muenster.de
Principal Investigator: H. G. Kehl, MD
Sub-Investigator: V. Debus, MD
Sub-Investigator: S. Kotthoff, MD
Sub-Investigator: S. Singer, MD
Germany, Saarland
Universitätsklinikum des Saarlandes	Recruiting
Homburg/Saar, Saarland, Germany, 66421
Contact: Hashim Abdul-Khaliq, Prof. +49 6841 16 28305 abdul-khaliq@uniklinikum-saarland.de
Principal Investigator: H. Abdul-Khaliq, Prof.
Sub-Investigator: A. Rentzsch, MD
Sub-Investigator: T. Raedle-Hurst, MD

Sponsors and Collaborators

Competence Network for Congenital Heart Defects

German Federal Ministry of Education and Research

Investigators

Study Chair:

Philipp Beerbaum, MD

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

More Information

Competence Network for Congenital Heart Defects This link exits the ClinicalTrials.gov site

Study ID Numbers:	MP4.3 Fallot-stress, EudraCT number: 2007-003461-41
Study First Received:	November 28, 2007
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00564993
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Pulmonary Valve Insufficiency
Heart Diseases
Cardiovascular Abnormalities
Tetralogy of Fallot
Fallot tetralogy

Stress
Congenital Abnormalities
Heart Defects, Congenital
Heart Valve Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009