Remote Ischemic Preconditioning With Postconditioning in Heart Transplantation Surgery

Heart Failure Clinical Trial

Official title:

Cardioprotective Effects of Remote Ischemic Preconditioning With Postconditioning of the Recipient on Donor Heart in Heart Transplantation Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02149316
• Other study ID #: FW2012-863B-C
• Status: Completed
• Phase: N/A
• First received: May 26, 2014
• Last updated: December 22, 2016
• Start date: February 2014
• Est. completion date: February 2016

Study information

• Verified date: December 2016
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether remote ischemic preconditioning with postconditioning (RIPC+RIPostC) reduces myocardial injury and improves clinical outcomes in heart transplantation surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 70 Years

Eligibility

Inclusion Criteria:

• scheduled for elective orthotopic heart transplantation surgery

Exclusion Criteria:

• peripheral vascular disease affecting the upper arms

• mechanical circulatory support before surgery

• taking the antidiabetic sulphonylurea, glibenclamide

• cold ischemic time of donor heart > 12 hours

• repeated heart surgery

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy
• End Stage Heart Disease
• Heart Diseases
• Heart Failure
• Ischemia
• Myocardial Ischemic Reperfusion Injury
• Myocardial Reperfusion Injury
• Reperfusion Injury

Intervention

Procedure:
• RIPC+RIPostC
Four 5 min cycles of upper limb ischemia and reperfusion by a cuff inflated to 200 mmHg, twice (after anesthesia induction and before surgery started, at 20min after aortic declamping)
• control
a deflated cuff placed on the right upper arm

Locations

Country	Name	City	State
China	State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS and PUMC	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum cardiac troponin I (cTnI)		within 72 hours after aortic declamping	No
Secondary	plasma microRNA-133b (miR-133b)		within 72 hours after aortic declamping	No
Secondary	plasma microRNA-208a (miR-208a)		within 72 hours after aortic declamping	No