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 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT04787393
Eligibility Criteria:
Inclusion criteria:
Patients with HF who recently (\< 6 months) received treatment with IV diuretics for worsening congestion or outpatients with HF and peripheral oedema (any degree) who are treated with at least 80 mg furosemide (or equivalent) orally per day Patients with HF older than 18 years Patients who took part in LOVE-HF can also be approached.
The research team will try to include as many patients as possible in the month following discharge, however we will not exclude consideration of a small proportion of patients within 6 months of decompensation. This has the extra advantage of demonstrating the value of the device beyond 1-2 months of decompensation.
Exclusion Criteria:
1. Inability to provide informed consent\*
2. Participant has bandages to lower limbs everyday
3. Participant has an amputation of the foot
4. Participant is a regular wheelchair user
5. Participant is of no fixed abode
6. Participant has a potentially reversible cause of decompensated heart failure and is awaiting urgent intervention (revascularisation/ valvular heart disease), which means the patient cannot be discharged for home-based care
7. Participant is taking part in a conflicting evaluation/study that could confound the results of this evaluation and/or impact clinical interventions and participant outcomes
8. Participant must not be pregnant, and is taking relevant birth control if of child-bearing potential\*
Note that a participant not able to comply with weighing, or questionnaires is NOT an exclusion criteria as the Heartfelt device should provide data for these participants despite their lack of ability to adhere to the usual monitoring protocol, and this is seen as one of the long term benefits that the device can provide.
* This exclusion criteria (a) has been added as participants would need to be able to communicate directly with the Heartfelt team, etc.
* This exclusion criteria (h) has been requested by the insurance provider for clinical trial cover.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04787393
Study Brief:
Protocol Section:
NCT04787393