Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12615001196538
Ethics application status
Approved
Date submitted
27/10/2015
Date registered
4/11/2015
Date last updated
1/11/2019
Date data sharing statement initially provided
27/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of the remote ischemic preconditioning on primary graft failure after heart transplantation: A Randomized Controlled Trial
Scientific title
Effect of the remote ischemic preconditioning on primary graft failure after heart transplantation: A Randomized Controlled Trial
Secondary ID [1] 287735 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
heart transplant rejection 296594 0
primary graft failure 296595 0
Condition category
Condition code
Surgery 296837 296837 0 0
Other surgery
Cardiovascular 296838 296838 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 293133 0
Treatment: Devices
Comparator / control treatment
Control patients will have sham placement of cuff without inflation.
Control group
Placebo

Outcomes
Primary outcome [1] 296447 0
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.
Timepoint [1] 296447 0
measured at 3h, 6h, 12h, 24h and 72h after heart transplant
Primary outcome [2] 296448 0
Proportion of participants with a reduction in post-transplant LVEF (assessed via routine echocardiogram)
Timepoint [2] 296448 0
measured at 24 hours, one week, one month, three months and six months after heart transplantation
Primary outcome [3] 296449 0
Proportion of participants with a reduction in troponin I (assessed by blood testing)
Timepoint [3] 296449 0
measured at baseline, three, six, 12, 24 and 72 hours after heart transplantation
Secondary outcome [1] 318470 0
Proportion of participants with a reduction in ICU stay (days) (assessed by review of hospital records)
Timepoint [1] 318470 0
recorded at six months after surgery
Secondary outcome [2] 318471 0
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)
Timepoint [2] 318471 0
recorded at six months after surgery
Secondary outcome [3] 318472 0
Proportion of participants with a reduction in hospital stay (days) (assessed by review of hospital records)
Timepoint [3] 318472 0
recorded at six months after surgery
Secondary outcome [4] 318520 0
Proportion of participants with a reduction in troponin T (assessed by blood testing) Note: this is a primary outcome.
Timepoint [4] 318520 0
measured at baseline, three, six, 12, 24 and 72 hours after heart transplantation

Eligibility
Key inclusion criteria
Adults and children aged >15 years undergoing heart transplantation for the first time.
Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients taking oral hypoglycaemic drugs (i.e., sulfonylurea derivatives, glyburide, or glibenclamide) will be excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
3/09/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
15
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 15084 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 28380 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 292279 0
Self funded/Unfunded
Name [1] 292279 0
N/A
Country [1] 292279 0
Primary sponsor type
Individual
Name
Professor Igor E. Konstantinov
Address
Royal Children’s Hospital
50 Flemington Road
Parkville VIC 3052
Australia
Country
Australia
Secondary sponsor category [1] 290964 0
None
Name [1] 290964 0
Address [1] 290964 0
Country [1] 290964 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293752 0
RCH HREC
Ethics committee address [1] 293752 0
Royal Children’s Hospital
50 Flemington Road
Parkville VIC 3052
Australia
Ethics committee country [1] 293752 0
Australia
Date submitted for ethics approval [1] 293752 0
17/10/2013
Approval date [1] 293752 0
28/01/2014
Ethics approval number [1] 293752 0
33224 B

Summary
Brief 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61178 0
Prof Igor E. Konstantinov
Address 61178 0
Royal Children’s Hospital
50 Flemington Road
Parkville VIC 3052
Australia
Country 61178 0
Australia
Phone 61178 0
61 3 9345 5200
Fax 61178 0
Email 61178 0
[email protected]
Contact person for public queries
Name 61179 0
Prof Igor E. Konstantinov
Address 61179 0
Royal Children’s Hospital
50 Flemington Road
Parkville VIC 3052
Australia
Country 61179 0
Australia
Phone 61179 0
61 3 9345 5200
Fax 61179 0
Email 61179 0
[email protected]
Contact person for scientific queries
Name 61180 0
Prof Igor E. Konstantinov
Address 61180 0
Royal Children’s Hospital
50 Flemington Road
Parkville VIC 3052
Australia
Country 61180 0
Australia
Phone 61180 0
61 3 9345 5200
Fax 61180 0
Email 61180 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.