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Fluid Guided Heart Failure Treatment at the Cleveland Clinic (FIGHT-HF)

Offene Rekrutierung
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT07205120 (FIGHT-HF) ist eine interventionsstudie zur Untersuchung von Herzinsuffizienz und hat den Status offene rekrutierung. Die Studie startete am 8. Oktober 2025 und soll 50 Teilnehmer aufnehmen. Durchgeführt von Bodyport Inc. ist der Abschluss für 1. März 2026 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 12. November 2025 aktualisiert.
Kurzbeschreibung
FIGHT-HF is an exploratory non-randomized open-label study evaluating a heart failure management intervention.

The goal of this pilot is to assess the performance of a fluid-guided heart failure management program and Alert Response Guide (ARG) using the Bodyport Cardiac Scale and Congestion Index in 50 adult participants with acute and chronic heart failure, who are followed by a Cleveland Clinic cardiologist.

Ausführliche Beschreibung
This study will assess the clinical integration of the Cardiac Scale and a composite biomarker algorithm, the Congestion Index and Alert, into existing health system workflows for HF management. The data collected in this study will be used to test and refine existing Congestion Index-guided HF management protocols contained within an Alert Response Guide (ARG). The final Alert Response Guide may be further validated in future randomized control trials.
Offizieller Titel

Fluid Guided Heart Failure Treatment

Erkrankungen
Herzinsuffizienz
Weitere Studien-IDs
  • FIGHT-HF
  • 25-529
NCT-Nummer
NCT07205120
Studienbeginn (tatsächlich)
2025-10-08
Zuletzt aktualisiert
2025-11-12
Studienende (vorauss.)
2026-03
Geplante Rekrutierung
50
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Stichwörter
scale
Primäres Ziel
Behandlung
Zuteilungsmethode
Nicht zutreffend
Interventionsmodell
Einarmige Studie
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellInterventional arm
Participants will begin receiving fluid-guided care when they begin using the device in the outpatient (home) setting. Participants will be monitored per routine clinical care and receive study follow-up visits at 45- and 90-days to assess clinical status, events, and medication changes.
Heart Failure Management Intervention
Participants will receive access to their weight and fluid levels on the Cardiac Scale and through the Bodyport Patient Portal. The provider will receive access to the Congestion Index, alerts, and Clinical Dashboard to support the remote management of the participant. The provider will receive a notice when an alert is generated and twice weekly reminders until the Congestion Index returns below an alert threshold. When an alert is generated, providers will attempt to contact the participant and will be encouraged to follow the recommendations contained within the ARG. Providers will also be encouraged to provide feedback and suggest improvements to the ARG throughout the study. Any changes to medical therapy resulting from an alert will be documented in the Bodyport Clinical Dashboard.
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Congestion Index Alert Statistics
From enrollment to the end of the study duration at 90 days
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
21 Years
Zugelassene Geschlechter
Alle
  • Hospitalized for acute decompensated heart failure
  • Age 21 years or older
  • Able to speak and read English

  • New York Heart Association functional class IV symptoms
  • Received or are scheduled to receive a heart transplant or ventricular assist - device in the next 12 months
  • Have a glomerular filtration rate of less than 25 mL/min while nonresponsive to diuretic therapy or on chronic renal dialysis
  • Have a history of regularly scheduled intravenous HF therapy (e.g., inotropes or diuretics)
  • Have a life expectancy of less than 12 months
  • Are pregnant or plan to become pregnant during the next 12 months
  • Weigh greater than 375 lbs
  • Unable to stand on two bare feet without assistance
Bodyport Inc. logoBodyport Inc.
Keine Kontaktdaten vorhanden
1 Studienstandorte in 1 Ländern

Ohio

The Cleveland Clinic, Cleveland, Ohio, 44195, United States
Elaine Franko, Kontakt, 216-444-9020, [email protected]
Offene Rekrutierung