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New treatment option for Heart Failure
Official title Monitoring Oedema in Heart Failure to Improve Function and Reduce Hospitalisation Risk
ClinicalTrials.gov ID: NCT07067658
What this study is testing
- What it's testing
- This study will evaluate the Heartfelt device, a novel, passive monitoring system that detects early signs of fluid build-up in patients (oedema) with heart failure by measuring changes in foot and lower leg volume through capture of 3D images. The trial will assess whether this device, when added to standard NHS care, improves quality of life and reduces heart failure-related events compared to standard care alone.
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants are eligible if they meet all General Criteria and at least one of Pathways A, B, or C. 1\. General Criteria (all participants must meet)
- Aged ≥18 years, AND
- Diagnosis of heart failure (any aetiology or LVEF classification), AND
- Documented or patient-reported moderate to severe leg oedema, AND
- Lives in the UK with a home environment suitable for installation of the Heartfelt device Pathway A: High risk patient with daily diuretics
You likely can't join if
- 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 treatment trial that may interfere with endpoints
See the full eligibility criteria
- Participants are eligible if they meet all General Criteria and at least one of Pathways A, B, or C. 1\. General Criteria (all participants must meet)
- Aged ≥18 years, AND
- Diagnosis of heart failure (any aetiology or LVEF classification), AND
- Documented or patient-reported moderate to severe leg oedema, AND
- Lives in the UK with a home environment suitable for installation of the Heartfelt device Pathway A: High risk patient with daily diuretics
- Currently prescribed ≥40 mg/day of furosemide (or equivalent loop diuretic, eg. bumetanide or torsemide) for at least one month, AND
- Any cardiorespiratory admission\ \ in the last 12 months (Includes outpatient IV diuretics, subcutaneous loop diuretics, or escalation to combination therapy with a loop diuretic and a thiazide or thiazide-like diuretic...
- Patients prescribed SGLT2 inhibitor (eg; dapagliflozin or empagliflozin) , AND
- Patients prescribed oral furosemide ≥40mg/day but advised to take it only as needed AND either: a) at least two admissions\ caused or complicated by worsening heart failure in the previous 12 months, OR b) a measurement...
- Uses an implantable device designed to monitor congestion (e.g. CardioMEMS, HeartLogic, or equivalent)
- Enrichment criteria: Patients must also meet a minimum total score of 4 from the characteristics below.
- NYHA class III and IV (score: 2)
- ≥80 mg/day Furosemide or equivalent loop diuretic (score: 2)
- \<3 Number of times the patient has weighed themselves in the last 2 weeks (score: 2)
- Help for essential daily activities required (score: 2)
- GRMT score \<5 (score: 2)
- Use of a walking stick, walker or mobility scooter (score: 2)
- \>2 Number of HF events in last 12 months (score: 2)
- Aged over 75 (score: 1)
- Health issues limiting daily activities (score: 1)
- Help getting to medical appointment required (score: 1)
- Problematic / not tolerated uptitration of medications: MRA (score: 1) SGLT2i (score: 1) Other (score: 1)
- English as a second language (score: 1)
- eGFR 20-45 (score: 1)
- Patient unable to regularly attend appointments for any reason (score: 1)
- \>3 Number of co-morbidities (score: 1)
- 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 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Aylesbury, Buckinghamshire, United Kingdom
- Croydon, Greater London, United Kingdom
- Welwyn Garden City, Hertfordshire, United Kingdom
- Patrington, Hull, United Kingdom
- Ashford, Kent, United Kingdom
- Lincoln, Lincolnshire, United Kingdom
- Hardwick, Stockton-on-Tees, United Kingdom
- Belfast, United Kingdom
- Bridgend, United Kingdom
- Glasgow, United Kingdom
- Hull, United Kingdom
- London, United Kingdom
- Manchester, United Kingdom
- Milton Keynes, United Kingdom
- Nottingham, United Kingdom
- Plymouth, United Kingdom
- Pont-y-clun, United Kingdom
- Walsall, United Kingdom
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aylesbury, Buckinghamshire, United Kingdom; Croydon, Greater London, United Kingdom; Welwyn Garden City, Hertfordshire, United Kingdom; Patrington, Hull, United Kingdom; Ashford, Kent, United Kingdom; Lincoln, Lincolnshire, United Kingdom and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.