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

Aortic Valve Disease Clinical Trial

— Custodiol-AV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02098772
• Other study ID #: CL-N-CSM-AV-III/05/12
• Status: Completed
• Phase: Phase 3
• Start date: May 2014
• Est. completion date: December 2018

Study information

• Verified date: February 2018
• Source: Dr. F. Köhler Chemie GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 530
• Est. completion date: December 2018
• Est. primary completion date: November 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Disease
• Coronary Artery Disease
• Coronary Artery Disease (CAD)

Intervention

Drug:
• Custodiol-N
comparison of two cardioplegic solutions, Custodiol-N versus Custodiol, in aortic valve surgery
• Custodiol
comparison of two cardioplegic solutions, Custodiol-N versus Custodiol, in aortic valve surgery

Locations

Country	Name	City	State
Germany	Klinik für Thorax-, Herz- und Gefäßchirurgie, Uniklinik der RWTH Aachen	Aachen
Germany	Klinik für Gefäßchirurgie, Universitäres Herzzentrum am UKE Hamburg	Hamburg
Germany	Klinik für Herzchirurgie, Universitätsklinikum Heidelberg	Heidelberg	Baden-Württemberg
Germany	Klinik für Herz- und Thoraxchirurgie Universitätsklinikum Jena	Jena	Thüringen
Germany	Klinik für Herzchirurgie Universität Leipzig/ Herzzentrum Leipzig	Leipzig	Sachsen
Germany	Klinik für Herz- und Gefäßchirurgie GmbH, Herz-Kreislauf-Zentrum Rotenburg	Rotenburg an der Fulda	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Dr. F. Köhler Chemie GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety parameters	documentation and reporting of AE and SAE	from time of the study inclusion up to the follow-up visit on day 5
Primary	peak value for CK-MB		measured at 4, 8, 12, 16, 20 and 24 hours after the release of the aortic cross clamp
Secondary	Catecholamine requirement on SICU		within 24 hours (cumulative dose)