Foot Oedema Observed Over Time Study

Launched by HEARTFELT TECHNOLOGIES · Aug 27, 2019

Keywords

ClinConnect Summary

This is a phase 2 observational study during which Subjects with chronic heart failure will be monitored in their home using the Heartfelt device.

The participant inclusion criteria will be those patients who are at high risk of hospital admission with a primary diagnosis of chronic heart failure or pulmonary oedema due to Heart failure (HF), during either of which peripheral oedema was also noted.

When heart failure decompensates, the amount of peripheral oedema that is clinically significant is unknown. The main objective of this study is to characterise the volume changes indicative of...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients age 18 years or older.
• • 2. Patient able, agrees and signs the Informed Consent Form.
• • 3. Patient with any heart failure diagnosis.
• • 4. Patient under the care of a cardiologist with heart failure nurse care.
• • 5. Patient with one prolonged inpatient stay
• • 6. Patient with significant peripheral oedema at admission
• • 7. Patient with significant weight loss following admission (at least 5kg weight loss).
• • 8. Patient has been discharged on at least furosemide 80mg or Bumetanide 2mg/d
• Exclusion Criteria:
• • 1. Patient has bandages everyday
• • 2. Patient has an amputation of the foot
• • 3. Patient lacks capacity to consent
• • 4. Patient is of no fixed abode
• • 5. Patient has plans for intervention (CRT, Valves)
• • 6. Patient taking part in another study
• • 7. Patient must not been pregnant, and is taking relevant birth control\*
• • Note that criteria (g) has been requested by the insurance for clinical trial cover. However we do not expect participants of this study to be trying to get pregnant (participants are expected to be over 55 years old).