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NCT04787380: LOVE-HF
Lancashire Objective Volume Evaluation of Leg Oedema in Heart Failure
NA trial testing Heartfelt device in Heart Failure in 27 participants. Completed in 30 September 2021.
30 September 2021
Quick facts
| Lead sponsor | Heartfelt Technologies |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | other |
| Enrollment | 27 |
| Start date | 5 March 2021 |
| Primary completion | 30 September 2021 |
| Estimated completion | 30 September 2021 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Heartfelt device
Conditions studied
- Heart Failure — all drugs for Heart Failure →
Sponsor
Heartfelt Technologies — full company profile →
Who can join
18 and older, any sex, with Heart Failure. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Patients with heart failure (HF) who recently received treatment with IV diuretics for worsening congestion or outpatients with HF and peripheral oedema treated with at least 80 mg furosemide (or equivalent)/day will be recruited for the LOVE-HF trial at Blackpool Victoria Hospital. Eligible participants will be randomized to use the Heartfelt Device alongside standard care (weighing + symptom reporting), or standard care alone. Participants and clinicians will be blinded (double blind) as to which arm participants are in, and after 30 days, participants will be crossed over to the other arm. This can be done without disrupting patients as the Heartfelt device can be switched remotely from a 'technical checks only' mode to a 'full data analysis' mode and vice versa. The investigators aim to recruit 30 participants for the pilot study. The study will also run in parallel with its sister pilot trial, LOVE-HF-2. Through this study, we are testing the capability to get the answers from patients, healthcare systems, and devices, in order to inform future clinical trial design.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04787380
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Heartfelt device
Trials testing the same drug.
- NCT04787393 — Lancashire Objective Volume Evaluation of Leg Oedema in Heart Failure Second Pilot · completed
Other recruiting trials for Heart Failure
Currently open trials in the same condition.
- NCT06118983 — Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home Health CaRe (I-TRANSFER-HF) · NA · recruiting
- NCT07496372 — Efficacy and Safety of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) in Advanced Heart · Phase 3 · recruiting
- NCT07527156 — Prolonged Nasogastric Administration of Ketones in Decompensated Heart Failure · Phase 4 · recruiting
- NCT07263035 — Urine Sodium-Driven Diuretic Adjustment Strategy in Acute Decompensated Heart Failure · Phase 4 · recruiting
- NCT07531966 — Vascular Complications After Kidney Transplantation · recruiting
Other Heartfelt Technologies trials
Trials by the same sponsor.
- NCT07067658 — Monitoring Oedema in Heart Failure to Improve Function and Reduce Hospitalisation Risk · NA · recruiting
- NCT06222099 — The HEARTFELT Study · NA · recruiting
- NCT06334822 — HF-TRACK: A UK RCT of an Passive Heart Failure Monitoring and Tracking Device · NA · active not recruiting
- NCT04787393 — Lancashire Objective Volume Evaluation of Leg Oedema in Heart Failure Second Pilot · completed
- NCT05193084 — Remote Monitoring of Ambulatory Intravenous Diuretics in Heart Failure · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04787380 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Heartfelt Technologies
- Last refreshed: 21 March 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04787380.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing