Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000011785
Ethics application status
Approved
Date submitted
29/11/2021
Date registered
11/01/2022
Date last updated
4/08/2023
Date data sharing statement initially provided
11/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating venous compliance in heart failure
Scientific title
Evaluating venous compliance in heart failure
Secondary ID [1] 305880 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart failure 324429 0
Condition category
Condition code
Cardiovascular 321925 321925 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Venous compliance measurement by strain gauge plethysmography in patients with diagnosed heart failure compared with healthy volunteers. Heart failure patients will require a single visit with the research team, an approximately 30 minute window following a clinically indicated procedure to participate in the study. We will collect the following information for all participants as screening procedures: vital signs including blood pressure and heart rate, a height and weight measurement to calculate BMI, an electrocardiogram, a physical examination and medication review by a medical doctor, a peripheral blood test for renal function, a full blood count and a NT-pro BNP as a marker of heart failure, an echocardiogram. We will also use data-linkage to medical records to collect all other relevant clinical information such as medical history or to use existing information like recently recorded echocardiogram reports if one has been performed within 3 months of enrolment to prevent the need to repeat these during the study. For the study itself a Venous occlusion by strain gauge plethysmography will be performed followed up a collection of blood using the same intravenous catheter used during the venous stiffness test.
Intervention code [1] 322274 0
Diagnosis / Prognosis
Comparator / control treatment
Venous compliance will also be measured in a group of healthy volunteers to collect baseline data for comparison with the investigational demographic.

Healthy volunteers will require a 2 hour visit for screening followed by a 1 hour visit on the study day within 14 days of screening to take part in the project.
Control group
Active

Outcomes
Primary outcome [1] 329668 0
To measure venous stiffness through strain-gauge plethysmography in heart failure patients compared with healthy volunteers as a baseline
Timepoint [1] 329668 0
on same day of investigation
Primary outcome [2] 329877 0
To compare measurements of venous stiffness in heart failure patients with central haemodynamics assessed during clinically indicated right heart catheterisation, and other clinical indicators of heart failure severity measured in echocardiography, vital signs, electrocardiogram and serum NT-proBNP levels
Timepoint [2] 329877 0
On the same day of investigation
Secondary outcome [1] 403387 0
Nil
Timepoint [1] 403387 0
Nil

Eligibility
Key inclusion criteria
Investigative group:
- diagnosed Heart failure, aiming for an equal share of 25 HFpEF patients and 25 HFrEF patients
- NYHA II-IV.
- Ischaemic or non-Ischaemic aetiology.
- Stable heart failure therapy for 1 month (a <50% adjustment to diuretics is permissible)

Healthy volunteers:
-never diagnosed with heart failure (nil diagnosis of cardiomyopathy)
Minimum age
45 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
o Prior heart transplantation
o Complex congenital heart disease
o Unstable heart failure requiring high dose inotropes (milrinone >15ug/min, dobutamine >5 ug/kg/min or adrenaline > 2ug/min) or mechanical circulatory support

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Venous compliance curves will be constructed as a function of venous pressure and the forearm volume and the venous diameter (as separate curves). Between group comparisons will be performed by Student's t-test. Correlation with measures of haemodynamic severity will be performed. Statistical analysis will be performed using SPSS or R.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/02/2022
Actual
1/04/2022
Date of last participant enrolment
Anticipated
31/03/2024
Actual
Date of last data collection
Anticipated
31/03/2024
Actual
Sample size
Target
70
Accrual to date
60
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 21196 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 36062 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 310226 0
Government body
Name [1] 310226 0
National Health and Medical Research Council of Australia
Country [1] 310226 0
Australia
Funding source category [2] 310227 0
Hospital
Name [2] 310227 0
The Alfred Hospital
Country [2] 310227 0
Australia
Primary sponsor type
Hospital
Name
The Alfred Hospital
Address
55 Commercial Road, Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 311324 0
None
Name [1] 311324 0
Address [1] 311324 0
Country [1] 311324 0
Other collaborator category [1] 282077 0
Other Collaborative groups
Name [1] 282077 0
Baker Heart and Diabetes Institute
Address [1] 282077 0
75 Commercial Rd, Melbourne VIC 3004
Country [1] 282077 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309911 0
Alfred Health Office of Ethics & Research Governance.
Ethics committee address [1] 309911 0
Level 2, 541 St Kilda Road , Melbourne VIC 3004
Ethics committee country [1] 309911 0
Australia
Date submitted for ethics approval [1] 309911 0
06/12/2021
Approval date [1] 309911 0
28/02/2022
Ethics approval number [1] 309911 0

Summary
Brief summary
This is a single centre, investigator-led study of venous compliance in patients with heart failure (heart failure with reduced ejection fraction: HFrEF and heart failure with preserved ejection fraction: HFpEF) and the relationship with central haemodynamics.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115802 0
Prof David Kaye
Address 115802 0
Heart Centre, Level 3 Phillip Block
The Alfred Hospital
55 Commercial Road, Melbourne VIC 3004
Country 115802 0
Australia
Phone 115802 0
+61 03 9076 2157
Fax 115802 0
Email 115802 0
d.kaye@alfred.org.au
Contact person for public queries
Name 115803 0
Ms Jia Tang
Address 115803 0
Heart Centre, Level 3 Phillip Block
The Alfred Hospital
55 Commercial Road, Melbourne VIC 3004
Country 115803 0
Australia
Phone 115803 0
+61 3 9076 2948
Fax 115803 0
Email 115803 0
j.tang@alfred.org.au
Contact person for scientific queries
Name 115804 0
Prof David Kaye
Address 115804 0
Heart Centre, Level 3 Phillip Block
The Alfred Hospital
55 Commercial Road, Melbourne VIC 3004
Country 115804 0
Australia
Phone 115804 0
+61 03 9076 2157
Fax 115804 0
Email 115804 0
d.kaye@alfred.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Raw data including confidential patient identifiers or details will not be disclosed or made available publicly.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14203Informed consent form    Healthy volunteers 383186-(Uploaded-15-12-2021-11-00-45)-Study-related document.pdf
14204Study protocol    383186-(Uploaded-15-12-2021-11-03-23)-Study-related document.pdf
14252Informed consent form    HF patients 383186-(Uploaded-15-12-2021-11-01-04)-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.