Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:35 AM
Ignite Modification Date:
2025-12-25 @ 2:35 AM
NCT ID:
NCT05026034
Eligibility Criteria:
Inclusion Criteria:
Written informed consent
* Male or female over18 years of age Cohort A
* Meet European Society of Cardiology 1 (ESC) criteria for diagnosis of HF
* Undergoing clinically-indicated RHC Cohort B
* Established on haemodialysis for \>90 days
* Undergoing haemodialysis with target volume removal ≥1.5 litres fluid Cohort C
* Meet ESC criteria for diagnosis of HF including heart failure
* Requiring treatment with intravenous (IV) diuretics Training Cohort
* Meet ESC criteria for diagnosis of HF including heart failure
* Requiring treatment with intravenous (IV) diuretics
Exclusion Criteria:
* Unable to consent to inclusion in study due to cognitive impairment
* Allergies or skin sensitivities to silicone-based adhesive
* Skin breakdown or dermatological condition on the left chest or breast areas or chest wall deformity where the device is placed
* Pregnancy or breast-feeding
* Conditions that may confound congestion assessments
* COVID-19 infection.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05026034
Study Brief:
Protocol Section:
NCT05026034