Last reviewed · How we verify
NCT02993601
Feasibility Study of a New Peripheral Oedema Monitor for Heart Failure
trial testing Heartfelt-1 in Heart Failure, Diastolic in 70 participants. Completed in 13 June 2017.
13 June 2017
Quick facts
| Lead sponsor | Heartfelt Technologies |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 70 |
| Start date | 15 January 2017 |
| Primary completion | 13 June 2017 |
| Estimated completion | 13 June 2017 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Heartfelt-1
- Weighing scales
- Medical grading of oedema
- Baseline assessements
- Water displacement method
- Callipers measurements
- Measuring tape
Conditions studied
- Heart Failure, Diastolic — all drugs for Heart Failure, Diastolic →
- Edema Brain — all drugs for Edema Brain →
- Decompensated Heartfailure — all drugs for Decompensated Heartfailure →
Sponsor
Heartfelt Technologies — full company profile →
Who can join
Adults 18 to 99, any sex, with Heart Failure, Diastolic or Edema Brain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The study aims at assessing the usefulness of the Heartfelt1 device in patients suffering from heart failure, who have peripheral oedema. The device is non-contact and does not requires patient compliance to work. It gives an output reading of the patient's lower leg volume. During the study, this measurement will be compared to clinical standard and gold standard measurements as well as clinical grading of peripheral oedema.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Evaluation of the Accuracy of a Video and AI Solution to Measure Lower Leg and Foot Volume.
Chausiaux O, Williams G, Nieznański M, Bagdu A, et al · · 2021 · cited 7× · PMID 33880069 · DOI 10.2147/mder.s297713
Verify or expand the search:
- PubMed search for NCT02993601
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Heart Failure, Diastolic
Currently open trials in the same condition.
- NCT07199088 — Comparative Efficacy and Safety of Acetazolamide Versus Metolazone as an Adjunct to Standard Therapy in Patients With Ac · NA · recruiting
- NCT05887271 — A Randomised, Controlled Trial of a Low-energy Diet for Improving Functional Status in Heart Failure With PRESERVED Ejec · Phase 2, PHASE3 · recruiting
- NCT05989945 — HIDRAdenitis Suppurativa and HEART Disease · active not recruiting
- NCT05752760 — Pilot Study Lp299v Supplementation in Chronic Heart Failure · NA · recruiting
- NCT06084468 — Cardiac Structure and Function in Patients with Cystic Fibrosis · active not 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 NCT02993601 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- 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: 13 October 2021
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/NCT02993601.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing