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:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-24 @ 11:58 PM
NCT ID:
NCT07067658
Eligibility Criteria:
Inclusion Criteria:
* Adults \>18 years
* Diagnosis of heart failure (any aetiology or left ventricular ejection fraction classification), any timeframe
* Currently prescribed ≥40 mg/day of furosemide (or equivalent loop diuretic) for at least one month.
* Heart failure hospital admission and moderate or severe leg oedema in the previous 12 months.
* Lives in the UK, with a home environment suitable for installation of the Heartfelt device.
Exclusion Criteria:
* Amputation of both feet
* Bed-bound for more than 20h per 24h period
* Bandages to lower limbs every day
* Regular wheelchair user inside their home
* No fixed abode
* Participation in another interventional trial that may interfere with endpoints
* Life expectancy \<6 months, in the opinion of the investigator
* Inability to provide informed consent due to cognitive impairment
* Language barriers that preclude understanding of trial procedures (unless translation resources are available in relevant language)
* Inability to install the device (even with assistance) allowing at least 6 months of data capture by the end of the study.
* Patients with severe aortic stenosis or awaiting a heart procedure or surgery
* Patient with end stage renal disease (eGFR \<20)
* Pregnancy or lack of contraceptive measures if of child-bearing potential
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07067658
Study Brief:
Protocol Section:
NCT07067658