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Phase III Study Comparing Two Methods of Cardioplegia in Aortic Valve Surgery Custodiol-N Versus Custodiol

Information source: Dr. F. Köhler Chemie GmbH
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Aortic Valve Disease; Coronary Artery Disease (CAD)

Intervention: Custodiol-N (Drug); Custodiol (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Dr. F. Köhler Chemie GmbH

Official(s) and/or principal investigator(s):
Gabor Szabó, Prof., Principal Investigator, Affiliation: Department of Cardiac Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg

Summary

The objective of this investigation is to compare the cardioprotective effects and safety of two cardioplegic solutions, HTK Cardioplegic Solution (Custodiol) and Custodiol-N in patients undergoing aortic valve surgery. The study design is a prospective, double blind, multicenter, randomized, Phase III comparison study intended to demonstrate superiority in surgical outcome between Custodiol and Custodiol-N as determined by CK-MB peak value 4-24 hours after opening of the aortic cross-clamp (primary endpoint), catecholamine requirement (cumulative dose) and cardiac Troponin T, occurrence of comorbid events postoperatively (e. g., myocardial infarction).

Clinical Details

Official title: A Prospective Randomized Double Blind Multicenter Phase III Study Comparing Two Methods of Cardioplegia in Aortic Valve Surgery Custodiol-N Versus Custodiol

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: peak value for CK-MB

Secondary outcome: Catecholamine requirement on SICU

Eligibility

Minimum age: 30 Years. Maximum age: 85 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients >/= 30 and

- Male or female with aortic valve disease

- Able to understand character and individual consequences of the clinical trial and to

provide written informed consent to participate in the study

- Women of childbearing potential (ie, those who have not undergone a hysterectomy or

who have not been post-menopausal for at least 12 consecutive months) must test negative for pregnancy prior to bypass surgery. Exclusion Criteria:

- History of recent (< 6 weeks) Q-wave myocardial infarction

- Left ventricular ejection fraction < 25% (as assessed by any one of the following:

contrast ventriculography, multigated acquisition scanning [MUGA], or 2-D ECHO)

- Patients on intra-aortic balloon devices or with history of previous coronary artery

bypass surgery

- Pregnant or lactating patients

- Patients who have participated in any other investigational studies within 30 days

previous to enrollment

- Patients in cardiogenic shock (defined as a systolic BP < 90 mmHg for over one hour

despite inotropic and chronotropic support)

- Patients with severe chronic obstructive lung disease (FEV1 < 50%)

- Previous cardiac valvular disease (clinical relevant)

- GFR <60 ml/min

- Planned Ross-procedure, Mitral valve surgery, Aortic valve reconstruction, double

valve surgery, other concomitant operations excluding coronary artery bypass surgery or closing a patent foramen ovale

- Evidence of severe organic (e. g. cirrhosis of the liver) or psychiatric disease by

history or physical examination

- History of alcohol abuse, illicit drug use, significant mental illness, physical

dependence to any opioid, or any history of drug abuse or addiction within 12 months of study enrollment.

Locations and Contacts

Klinik für Thorax-, Herz- und Gefäßchirurgie, Uniklinik der RWTH Aachen, Aachen 52074, Germany; Recruiting
Rüdiger Autschbach, Prof. Dr. med., Phone: 0241, Ext: 8089221, Email: rautschbach@ukaachen.de
Andreas Goetzenich, PD Dr. med., Phone: 0241, Ext: 8035556, Email: agoetzenich@ukaachen.de

Klinik für Gefäßchirurgie, Universitäres Herzzentrum am UKE Hamburg, Hamburg 20246, Germany; Recruiting
Florian Wagner, Dr. med., Phone: +49 40 74105 8949, Email: fl.wagner@uke.de
Johannes Schirmer, Dr. med.
Florian Wagner, Dr. med., Principal Investigator
Johannes Schirmer, Dr. med., Sub-Investigator

Klinik für Herzchirurgie, Universitätsklinikum Heidelberg, Heidelberg, Baden-Württemberg 69120, Germany; Recruiting
Gabor Szabo, Prof. Dr. med., Phone: +49 6221 566 111, Email: Gabor.Szabo@urz.uni-heidelberg.de
Gabor Veres, Dr. med., Phone: +49 6221 56 36126
Gabor Szabo, Prof. Dr. med., Principal Investigator
Alexander Weymann, Dr. med., Sub-Investigator
Gabor Veres, Dr. med., Sub-Investigator

Klinik für Herz- und Gefäßchirurgie GmbH, Herz-Kreislauf-Zentrum Rotenburg, Rotenburg an der Fulda, Hessen 36199, Germany; Active, not recruiting

Klinik für Herzchirurgie Universität Leipzig/ Herzzentrum Leipzig, Leipzig, Sachsen 04289, Germany; Recruiting
Martin Misfeld, Prof. Dr. med., Phone: +49 341 865 0, Email: Martin.Misfeld@herzzentrum-leipzig.de
Piroze Davierwala, Dr. med., Phone: +49 341 865 251 049
Martin Misfeld, Prof. Dr. med., Principal Investigator
Piroze Davierwala, D. med., Sub-Investigator

Klinik für Herz- und Thoraxchirurgie Universitätsklinikum Jena, Jena, Thüringen 07747, Germany; Recruiting
Thorsten Doenst, Prof. Dr. med, Phone: +49 3641 932 2901, Email: doenst@med.uni-jena.de
Paulo Amorim, Dr., Phone: +49 3641 932 2948, Email: Paulo.amorim@med.uni-jena.de
Thorsten Doenst, Prof. Dr. med., Principal Investigator
Paulo Amorim, Dr. med., Sub-Investigator
Tim Sandhaus, Dr. med., Sub-Investigator

Additional Information

Starting date: May 2014
Last updated: February 20, 2015

Page last updated: August 23, 2015

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