CompletedNCT02149316Updated Dec 23, 2016

Remote Ischemic Preconditioning With Postconditioning in Heart Transplantation Surgery

An interventional study of RIPC+RIPostC and control in Myocardial Ischemic Reperfusion Injury, End Stage Heart Disease and Heart Failure, sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital. Completed at 1 site in China. Open to participants aged 14 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-12-23.

Sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital · Not applicable, Interventional, and Supportive care

Phase: Not applicable
Study type: Interventional
Enrollment: 60
Allocation: Randomized
Ages: 14 Years to 70 Years
Sex: All

Study 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.

Conditions studied

Myocardial Ischemic Reperfusion Injury
End Stage Heart Disease
Heart Failure
Cardiomyopathy

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In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's enrollment of 60 is below the median of 100 across 1,778 interventional studies indexed under Heart Diseases.

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Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital is the lead sponsor of 141 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 14 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

scheduled for elective orthotopic heart transplantation surgery

Exclusion criteria

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

Phase: Not applicable
Primary purpose: Supportive care
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Care provider)
Enrollment: 60 participants (actual)

Study arms

Experimental
RIPC+RIPostC
Procedure: RIPC+RIPostC
Sham comparator
control
Procedure: control

Interventions

ProcedureRIPC+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)
Procedurecontrol
a deflated cuff placed on the right upper arm

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

1 site

State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS and PUMC
Beijing, 100037, China

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 23, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02149316
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Responsible party: Guyan Wang (The Chief of Infection-Control Department, Chinese Academy of Medical Sciences, Fuwai Hospital) — Principal investigator
First posted: May 29, 2014
Start date: Feb 2014
Primary completion: Feb 2016
Completion: Feb 2016
Last update: Dec 23, 2016

Study contacts

Guyan Wang, PhD

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

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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