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

Not Applicable

Recruiting

• Conditions: heart transplant rejection; primary graft failure; Surgery - Other surgery; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12615001196538
• Lead Sponsor: Professor Igor E. Konstantinov

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Adults and children aged >15 years undergoing heart transplantation for the first time.

Exclusion Criteria

Patients taking oral hypoglycaemic drugs (i.e., sulfonylurea derivatives, glyburide, or glibenclamide) will be excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of participants with a reduction in post-transplant need for high-dose inotropes or circulatory support (this is a composite primary outcome). This will be assessed by review of hospital records.[measured at 3h, 6h, 12h, 24h and 72h after heart transplant];Proportion of participants with a reduction in post-transplant LVEF (assessed via routine echocardiogram)[measured at 24 hours, one week, one month, three months and six months after heart transplantation];Proportion of participants with a reduction in troponin I (assessed by blood testing)[measured at baseline, three, six, 12, 24 and 72 hours after heart transplantation]

Secondary Outcome Measures

Name	Time	Method
Proportion of participants with a reduction in ICU stay (days) (assessed by review of hospital records)<br><br>[recorded at six months after surgery];Proportion of participants with a reduction in number of treated rejection episodes during the first six months after heart transplant (assessed by review of hospital records)[recorded at six months after surgery];Proportion of participants with a reduction in hospital stay (days) (assessed by review of hospital records)[recorded at six months after surgery];Proportion of participants with a reduction in troponin T (assessed by blood testing) Note: this is a primary outcome.[measured at baseline, three, six, 12, 24 and 72 hours after heart transplantation]