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
ACTRN12618001163291
Ethics application status
Approved
Date submitted
22/06/2018
Date registered
13/07/2018
Date last updated
14/01/2021
Date data sharing statement initially provided
14/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The biochemical and molecular identity of hormones in the human heart
Scientific title
The biochemical and molecular identity of hormones in the human heart in heart transplant patients
Secondary ID [1] 295284 0
None
Universal Trial Number (UTN)
U1111-1216-0437
Trial acronym
The HEART-MAP study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiology 308453 0
Heart transpant 308509 0
Condition category
Condition code
Cardiovascular 307435 307435 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
12 patients in the Auckland Heart Transplant programme will be invited to participate in a study to measure the gene and protein levels of various hormones in the heart and blood. Participants will be asked to complete a questionnaire about their past medical history, medications, social history (tobacco and alcohol use) and demographic details (age, sex, ethnic group). Blood samples (20ml volume) will be taken at the time of transplant surgery. Participants are not followed up after completion of transplant surgery.
We also require 10grams of tissue from each of the atrium and ventricle chambers of the explanted heart.
Intervention code [1] 301608 0
Not applicable
Comparator / control treatment
none
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306400 0
Composite clinical outcomes include success of transplantation, rejection events, morbidity with respect to alternate organ failure and general outcomes such as exercise ability etc. This data is obtained via the NZ Heart Transplant Program Medical Records system.
Timepoint [1] 306400 0
The time points of <30 days, 6 months, and then yearly assessments.
Secondary outcome [1] 348393 0
A secondary outcome will be more precise and sophisticated mass spectrometry analysis of target peptides in explant heart tissue.
Timepoint [1] 348393 0
at the time of transplant
Secondary outcome [2] 348732 0
The cause of heart failure or disease requiring transplant will be correlated with the peptide modifications observed. We will simply observe if the presence or absence of peptide modifications bear any relationship the etiology of the explanted hearts. The presence or absence of peptide modifications will be assessed by high performance liquid chromatography and mass spectrometry
Timepoint [2] 348732 0
At the time of transplant

Eligibility
Key inclusion criteria
All participants on the cardiac transplant waiting list aged 18-63
will be invited to participate.
Minimum age
18 Years
Maximum age
63 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
unable or unwilling to participate

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
The study itself has a straight forward and appropriate design. The group involved has access to the cardiac tissue and extensive experience in the methods which will be used. Appropriate consent for use of the tissue will be obtained from those patients having cardiac transplantation. The information provided from the transplant centre suggests an appropriate number of tissue samples will be obtained over a very reasonable time frame of around 2-3 years. A relatively limited number of people undergo heart transplantation, but this is a unique source of human cardiac tissue and numbers be adequate to provide important and significant information.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
27/02/2018
Date of last participant enrolment
Anticipated
31/12/2021
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
2
Final
Recruitment outside Australia
Country [1] 10579 0
New Zealand
State/province [1] 10579 0
Auckland

Funding & Sponsors
Funding source category [1] 299866 0
Charities/Societies/Foundations
Name [1] 299866 0
The Christchurch Heart Institute Trust
Country [1] 299866 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
The Christchurch Heart Institute Trust
Address
Department of Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 299219 0
None
Name [1] 299219 0
Address [1] 299219 0
Country [1] 299219 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300737 0
Health and Disability Ethics Committees
Ethics committee address [1] 300737 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 300737 0
New Zealand
Date submitted for ethics approval [1] 300737 0
22/05/2017
Approval date [1] 300737 0
22/06/2017
Ethics approval number [1] 300737 0
17/STH/80

Summary
Brief summary
12 patients in the Auckland Heart Transplant programme will be invited to participate in a study to measure the gene and protein levels of various hormones in the heart and blood. These hormones are important in controlling blood pressure and the load placed upon the heart. We are investigating which hormones are potentially important in the development of heart problems. Measurements of these hormones could potentially be useful for clinical disease diagnosis and outcome.
Participants will be asked to give consent for the use of their heart tissue and blood for this study. They will be asked to complete a questionnaire about their health and demographic details.
Blood samples (20ml volume) will be taken at the time of the transplant surgery.
We also require 10grams of tissue from each of the atrium and ventricle chambers of the heart. This will be taken from the heart removed at the time of surgery. The process of taking this tissue will in no way compromise the safety and procedure of surgery or affect standard clinical care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84646 0
A/Prof Christopher Pemberton
Address 84646 0
Christchurch Heart Institute
Department of Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
Country 84646 0
New Zealand
Phone 84646 0
+6433640887
Fax 84646 0
+6433641115
Email 84646 0
[email protected]
Contact person for public queries
Name 84647 0
A/Prof Chris Pemberton
Address 84647 0
Christchurch Heart Institute
Department of Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
Country 84647 0
New Zealand
Phone 84647 0
+6433640887
Fax 84647 0
+6433641115
Email 84647 0
[email protected]
Contact person for scientific queries
Name 84648 0
A/Prof Christopher Pemberton
Address 84648 0
Christchurch Heart Institute
Department of Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
Country 84648 0
New Zealand
Phone 84648 0
+6433640887
Fax 84648 0
+6433641115
Email 84648 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.