Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001725853
Ethics application status
Approved
Date submitted
21/10/2021
Date registered
16/12/2021
Date last updated
21/07/2024
Date data sharing statement initially provided
16/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Inter-organ cross talk in heart failure: A multisite biomarker sampling study
Scientific title
Inter-organ cross talk in heart failure: A multisite biomarker sampling study
Secondary ID [1] 305612 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
heart failure 324043 0
Condition category
Condition code
Cardiovascular 321550 321550 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a single centre, investigator-led study of the regional origins of biomarkers in patients with heart failure (heart failure with reduced ejection fraction: HFrEF, and heart failure with preserved ejection fraction: HFpEF) , and of the relationship between biomarkers in cardiovascular function.
It consists of two parts of visit: initial visit will assess participants' eligibility via face-to face consultation. If they are qualified, patients will proceed for second visit which is the procedure called right heart catheterization.
The right heart catheterisation will take around one hour on your second visit. It involves insertion of a catheter (a thin plastic tube) into a large vein usually in the arm but sometimes in the right side of the neck (jugular vein) using ultrasound to identify the correct placement. Through this tube a smaller tube will be advanced step by step to the heart, lungs, kidney and liver using x-ray guidance to measure the blood pressure and to collect a blood sample from each location. A fine tube will also be placed into an artery located at the wrist or elbow under local anaesthetic to measure your blood pressure and to collect blood samples.
There is a visit checklist detailing the component of each visit including vital signs, blood samples, medical history etc. and further details are explained in the PICF.
Patients having heart failure with reduced ejection fraction and patients with preserved ejection fraction will undergo the same procedures.
Intervention code [1] 322015 0
Diagnosis / Prognosis
Comparator / control treatment
healthy control subjects
Control group
Active

Outcomes
Primary outcome [1] 329317 0
methods of assessment: all samples will be assessed as a composite primary outcome including arterial blood, coronary sinus blood and renal venous blood
outcome: the outcomes of biomarkers include and not limited to small molecule metabolites, NT proBNP, troponin I, miRNA
Timepoint [1] 329317 0
end of regional catheterization
Primary outcome [2] 329574 0
hepatic venous blood will be assessed as the primary outcome including inflammatory biomarkers that are exploratory as this cannot be explained by cardiac release
Timepoint [2] 329574 0
end of right heart catheterization procedure
Secondary outcome [1] 402114 0

cardio-renal signaling biomarkers including NTproBNP, miRNA, proteins assessed using blood samples

Timepoint [1] 402114 0
at the completion of right heart catheterization procedure
at the completion of initial screening visit
Secondary outcome [2] 403070 0
cardiac performance via haemodynamics assessed by Swan Ganz catheter and echocardiography
Timepoint [2] 403070 0
at end of procedure
Secondary outcome [3] 403071 0
heart function is assessed by 6-minute walk test and echocardiography
Timepoint [3] 403071 0
at end of procedure
Secondary outcome [4] 403072 0
quality of life via questionaires of EQ5D-5L
Timepoint [4] 403072 0
at end of procedure
Secondary outcome [5] 403718 0
renal functions are assessed via blood test of eGFR
Timepoint [5] 403718 0
at end of procedure
Secondary outcome [6] 403719 0
Medications are assessed via collecting the con-conmittent medication at each visit
Timepoint [6] 403719 0
at end of each visit

Eligibility
Key inclusion criteria
Inclusion Criteria:

Heart failure either HFpEF (n=50) or HFrEF (n=50)
NYHA II-IV.
Ischaemic or non-Ischaemic aetiology.
Stable heart failure therapy for 1 month (a <50% adjustment to diuretics is permissible)
Age: more than 18 years old
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria:

Prior heart transplantation
Complex congenital heart disease
Unstable heart failure requiring high dose inotropes (milrinone >15ug/min, dobutamine >5 ug/kg/min or adrenaline > 2ug/min) or mechanical circulatory support.
Pregnant women
For healthy controls: if any problems of heart failure are detected during screening


Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/01/2022
Actual
22/02/2022
Date of last participant enrolment
Anticipated
1/07/2025
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
125
Accrual to date
38
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 20821 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 35646 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 309973 0
Government body
Name [1] 309973 0
National Health and Medical Research Council
Country [1] 309973 0
Australia
Primary sponsor type
Hospital
Name
ALFRED HOSPITAL
Address
55 COMMERCIAL ROAD
Melbourne
3004
Victoria
Country
Australia
Secondary sponsor category [1] 311021 0
None
Name [1] 311021 0
Address [1] 311021 0
Country [1] 311021 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309684 0
ALFRED ETHICS COMMITTEE
Ethics committee address [1] 309684 0
Ethics committee country [1] 309684 0
Australia
Date submitted for ethics approval [1] 309684 0
18/10/2021
Approval date [1] 309684 0
16/12/2021
Ethics approval number [1] 309684 0

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

Contacts
Principal investigator
Name 115034 0
Prof David Kaye
Address 115034 0
55 commercial road, Melbourne, 3004, Victoria
Alfred Health
Country 115034 0
Australia
Phone 115034 0
+61390762461
Fax 115034 0
Email 115034 0
[email protected]
Contact person for public queries
Name 115035 0
David Kaye
Address 115035 0
55 commercial road, Melbourne, 3004, Victoria
Alfred health
Country 115035 0
Australia
Phone 115035 0
+61390763040
Fax 115035 0
Email 115035 0
[email protected]
Contact person for scientific queries
Name 115036 0
David Kaye
Address 115036 0
55 commercial road, Melbourne, Victoria, 3004
Alfred health
Country 115036 0
Australia
Phone 115036 0
+61390763040
Fax 115036 0
Email 115036 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13688Study protocol    382994-(Uploaded-21-10-2021-11-22-11)-Study-related document.docx
13689Informed consent form    382994-(Uploaded-16-11-2021-10-11-38)-Study-related document.pdf



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.