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Inter-organ cross talk in heart failure: A multisite biomarker sampling study

Inter-organ cross talk in heart failure: A multisite biomarker sampling study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001725853
Enrollment
38
Registered
2021-12-16
Start date
2022-02-22
Completion date
2025-07-01
Last updated
2024-07-29

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 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 in healthy control subjects, and of the relationship between biomarkers in cardiovascular function. The past studies have demonstrated the association between many biomarkers in the peripheral blood only and the regional blood is somewhat lack of information. This study is hypothesized to investigate the biomarkers at regional blood sampling to better understand the pathophysiology of heart failure

Interventions

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 pr

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.

Sponsors

ALFRED HOSPITAL
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Primary purpose
Diagnosis

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years
Healthy volunteers
Yes

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026