Remote Ischemic Preconditioning With Postconditioning in Heart Transplantation Surgery

NCT ID: NCT02149316

Last Updated: 2016-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2016-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Myocardial Ischemic Reperfusion Injury End Stage Heart Disease Heart Failure Cardiomyopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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RIPC+RIPostC

Group Type EXPERIMENTAL

RIPC+RIPostC

Intervention Type PROCEDURE

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

Group Type SHAM_COMPARATOR

control

Intervention Type PROCEDURE

a deflated cuff placed on the right upper arm

Interventions

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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)

Intervention Type PROCEDURE

control

a deflated cuff placed on the right upper arm

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Guyan Wang

The Chief of Infection-Control Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guyan Wang, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS and PUMC

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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FW2012-863B-C

Identifier Type: -

Identifier Source: org_study_id