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Evaluating venous compliance in heart failure

Evaluating venous compliance in heart failure

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12622000011785
Enrollment
47
Registered
2022-01-11
Start date
2022-04-01
Completion date
2024-02-08
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 calcul

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.

Sponsors

The Alfred Hospital
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
45 Years to 70 Years
Healthy volunteers
Yes

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)

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

Outcome results

None listed

Source: ANZCTR · Data processed: Sep 17, 2026