RecruitingACTRN12615001196538

Effect of the remote ischemic preconditioning on primary graft failure after heart transplantation: A Randomized Controlled Trial

Sponsor

Professor Igor E. Konstantinov

Enrollment

50 participants

Start Date

Sep 3, 2015

Study Type

Interventional

Conditions

heart transplant rejection primary graft failure

Summary

Objectives of this study are to assess the effects of the remote ischemic preconditioning (RIPC) on the primary graft failure (PGF), heart function and multi-organ protection after heart transplantation. This is a prospective, multi-centre, double-blind randomized controlled clinical trial (RCT). The outcome of the study is expected to determine if significant protection by the RIPC previously achieved in animal study can be translated into clinical heart transplantation. Study Duration: Three years. Intervention is the RIPC stimulus (also referred to as ‘protocol’) which consists of four five-minute cycles of arm ischemia with intervening five minutes of reperfusion following induction of standard anaesthesia in the operating room, prior to heart transplantation (HT). Inflating a standard blood pressure cuff to a pressure exceeding systolic by 20 mmHg will interrupt blood flow. The cuff would be deflated during reperfusion. Control patients will have sham placement of cuff without inflation. Participants will be monitored after HT and an analysis of blood samples (involving an examination of markers of myocardial damage, i.e., troponin I) collected as a part of standard care will be used to determine if there are protective effects due to the RIPC protocol used. Number of Subjects: 50. Population: Adults and children aged >15 years undergoing heart transplantation for the first time.

Eligibility

Sex: Both males and femalesMin Age: 15 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether a technique called remote ischemic preconditioning (RIPC) can protect the heart during a heart transplant. RIPC involves briefly inflating a blood pressure cuff on the arm to temporarily restrict blood flow, which may help make the heart more resilient before transplant surgery. Researchers will check if it reduces heart damage and improves recovery after transplantation. You may be eligible if: - You are 15 years or older - You are scheduled to receive your first heart transplant You may NOT be eligible if: - You are taking oral blood sugar-lowering drugs such as sulfonylurea, glyburide, or glibenclamide Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The intervention is the application of remote ischaemic preconditioning (RIPC) protocol to patients undergoing heart transplantation. The RIPC protocol will be instituted by four five-minute cycles of arm ischaemia with intervening five minutes of reperfusion following induction of standard anaesthesia in the operating room. Inflating a standard blood pressure cuff to a pressure exceeding systolic by 20 mmHg will interrupt blood flow. The cuff would be deflated during reperfusion. Blood flow interruption and restoration will be documented by a standard finger pulse oximetry, which will serve to monitor adherence. Control patients will have sham placement of cuff without inflation. For early effect, the preconditioning will be performed after the patient has been anaesthetised while routine central lines are being placed, prior to heart transplantation.

Locations(1)

The Alfred - Melbourne

NSW,VIC, Australia

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ACTRN12615001196538