Remote Ischemic Preconditioning With Postconditioning in Heart Transplantation Surgery

Overview

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.

Full Title of Study: “Cardioprotective Effects of Remote Ischemic Preconditioning With Postconditioning of the Recipient on Donor Heart in Heart Transplantation Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: February 2016

Interventions

  • 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)
  • Procedure: control
    • a deflated cuff placed on the right upper arm

Arms, Groups and Cohorts

  • Experimental: RIPC+RIPostC
  • Sham Comparator: control

Clinical Trial Outcome Measures

Primary Measures

  • serum cardiac troponin I (cTnI)
    • Time Frame: within 72 hours after aortic declamping

Secondary Measures

  • plasma microRNA-133b (miR-133b)
    • Time Frame: within 72 hours after aortic declamping
  • plasma microRNA-208a (miR-208a)
    • Time Frame: within 72 hours after aortic declamping

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 14 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chinese Academy of Medical Sciences, Fuwai Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Guyan Wang, The Chief of Infection-Control Department – Chinese Academy of Medical Sciences, Fuwai Hospital
  • Overall Official(s)
    • Guyan Wang, PhD, Principal Investigator, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS and PUMC, Beijing, China

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