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

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ClinicalTrials.gov Identifier: NCT02098772
Recruitment Status : Recruiting
First Posted : March 28, 2014
Last Update Posted : February 21, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. F. Köhler Chemie GmbH

Brief 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).

Condition or disease Intervention/treatment Phase
Aortic Valve Disease Coronary Artery Disease (CAD) Drug: Custodiol-N Drug: Custodiol Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 530 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : May 2014
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Custodiol-N
comparison of two cardioplegic solutions, Custodiol-N versus Custodiol, in aortic valve surgery
Drug: Custodiol-N
comparison of two cardioplegic solutions, Custodiol-N versus Custodiol, in aortic valve surgery
Active Comparator: Custodiol
comparison of two cardioplegic solutions, Custodiol-N versus Custodiol, in aortic valve surgery
Drug: Custodiol
comparison of two cardioplegic solutions, Custodiol-N versus Custodiol, in aortic valve surgery



Primary Outcome Measures :
  1. peak value for CK-MB [ Time Frame: measured at 4, 8, 12, 16, 20 and 24 hours after the release of the aortic cross clamp ]

Secondary Outcome Measures :
  1. Catecholamine requirement on SICU [ Time Frame: within 24 hours (cumulative dose) ]

Other Outcome Measures:
  1. Safety [ Time Frame: from time of the study inclusion up to the follow-up visit on day 5 ]
    documentation and reporting of AE and SAE



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients >/= 30 and </= 85 years of age
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02098772


Locations
Germany
Klinik für Herzchirurgie, Universitätsklinikum Heidelberg Recruiting
Heidelberg, Baden-Württemberg, Germany, 69120
Contact: Gabor Szabo, Prof. Dr. med.    +49 6221 566 111    Gabor.Szabo@urz.uni-heidelberg.de   
Contact: Gabor Veres, Dr. med.    +49 6221 56 36126      
Principal Investigator: Gabor Szabo, Prof. Dr. med.         
Sub-Investigator: Alexander Weymann, Dr. med.         
Sub-Investigator: Gabor Veres, Dr. med.         
Klinik für Herz- und Gefäßchirurgie GmbH, Herz-Kreislauf-Zentrum Rotenburg Recruiting
Rotenburg an der Fulda, Hessen, Germany, 36199
Contact: Ardawan Rastan, Dr. med.    +49 6623 88 5858    A.Rastan@hkz-rotenburg.de   
Contact: Jürgen Graff, Dr. med.    +49 6623 88 5855    j.graff@hkz-rotenburg.de   
Principal Investigator: Ardawan Rastan, Dr. med.         
Sub-Investigator: Jürgen Graff, Dr. med.         
Klinik für Herzchirurgie Universität Leipzig/ Herzzentrum Leipzig Active, not recruiting
Leipzig, Sachsen, Germany, 04289
Klinik für Herz- und Thoraxchirurgie Universitätsklinikum Jena Recruiting
Jena, Thüringen, Germany, 07747
Contact: Thorsten Doenst, Prof. Dr. med    +49 3641 932 2901    doenst@med.uni-jena.de   
Contact: Paulo Amorim, Dr.    +49 3641 932 2948    Paulo.amorim@med.uni-jena.de   
Principal Investigator: Thorsten Doenst, Prof. Dr. med.         
Sub-Investigator: Paulo Amorim, Dr. med.         
Sub-Investigator: Tim Sandhaus, Dr. med.         
Klinik für Thorax-, Herz- und Gefäßchirurgie, Uniklinik der RWTH Aachen Recruiting
Aachen, Germany, 52074
Contact: Rüdiger Autschbach, Prof. Dr. med.    0241 ext 8089221    rautschbach@ukaachen.de   
Contact: Andreas Goetzenich, PD Dr. med.    0241 ext 8035556    agoetzenich@ukaachen.de   
Klinik für Gefäßchirurgie, Universitäres Herzzentrum am UKE Hamburg Recruiting
Hamburg, Germany, 20246
Contact: Florian Wagner, Dr. med.    +49 40 74105 8949    fl.wagner@uke.de   
Contact: Johannes Schirmer, Dr. med.         
Principal Investigator: Florian Wagner, Dr. med.         
Sub-Investigator: Johannes Schirmer, Dr. med.         
Sponsors and Collaborators
Dr. F. Köhler Chemie GmbH
Investigators
Principal Investigator: Gabor Szabó, Prof. Department of Cardiac Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg

Responsible Party: Dr. F. Köhler Chemie GmbH
ClinicalTrials.gov Identifier: NCT02098772     History of Changes
Other Study ID Numbers: CL-N-CSM-AV-III/05/12
First Posted: March 28, 2014    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: February 2018

Keywords provided by Dr. F. Köhler Chemie GmbH:
aortic valve disease
coronary bypass surgery
cardioplegic solutions

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Heart Defects, Congenital
Heart Valve Diseases
Heart Diseases
Myocardial Ischemia
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities
Pharmaceutical Solutions
Cardioplegic Solutions