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Die klinische Studie NCT06218199 (DART-HA) für Kongestive Herzinsuffizienz ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen.
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Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts (DART-HA) Phase 4 80 Offene Studie

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 NCT06218199 (DART-HA) untersucht Behandlung im Zusammenhang mit Kongestive Herzinsuffizienz. Diese interventionsstudie der Phase 4 hat den Status offene rekrutierung und startete am 8. Juli 2021. Es ist geplant, 80 Teilnehmer aufzunehmen. Durchgeführt von Heart Center Research, LLC wird der Abschluss für 31. Dezember 2026 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 29. Januar 2024 aktualisiert.
Kurzbeschreibung
The DART-HA study is a single-center, open label, trial intended to evaluate the clinical efficacy of standard treatment options for congestive heart failure (observation, diuretic or afterload reduction therapy) in patients without new symptoms who have developed abnormalities of the HeartLogic heart failure diagnostic feature.
Ausführliche Beschreibung
Subjects with congestive heart failure (CHF) who have undergone implantation of a Boston Scientific pacemaker/defibrillator with a HeartLogic sensor will be remotely monitored for for elevation of their HeartLogic score which is indicative of worsening heart failure. Subjects whose devices demonstrate HeartLogic score elevations and also do not demonstrate symptoms from heart failure will be randomized to observation...Mehr anzeigen
Offizieller Titel

Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts (DART-HA)

Erkrankungen
Kongestive Herzinsuffizienz
Publikationen
Wissenschaftliche Artikel und Forschungspapiere zu dieser klinischen Studie:
Weitere Studien-IDs
  • DART-HA
  • Dart-HA
NCT-Nummer
NCT06218199
Studienbeginn (tatsächlich)
2021-07-08
Zuletzt aktualisiert
2024-01-29
Studienende (vorauss.)
2026-12-31
Geplante Rekrutierung
80
Studientyp
Interventionsstudie
PHASE
Phase 4
Status
Offene Rekrutierung
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
Aktives VergleichspräparatDiuretic protocol
If asymptomatic at time of HeartLogic(HL) alert, will add or increase diuretic based on current medications. If currently taking ≤ 20 mg. furosemide, begin furosemide 40mg orally daily until recovery from alert or re-alert. If currently taking ≥ 40mg furosemide begin torsemide 20 mg orally daily or bumetanide 1 mg orally daily. If patient unable to obtain torsemide or bumetanide double furosemide daily dose (maximum...Mehr anzeigen
Furosemide
oral administration
Torsemide
oral administration
Bumetanide
oral administration
Aktives VergleichspräparatAfterload reduction protocol
If asymptomatic at time of HL alert, increase afterload reduction drugs based on current medications. If on Sacubitril/valsartan, double the dose. If on maximum Sacubitril/valsartan, add Hydralazine 10mg and Isordil10 mg both three times a day. If on Angiotensin Receptor Blocker (ARB) at low dose (less than or equal to Valsartan 160mg daily or equivalent) then stop ARB and start sacubitril/valsartan 24-26mg twice a ...Mehr anzeigen
sacubitril/valsartan
oral administration
Hydralazine
oral administration
Isosorbide Dinitrate
oral administration
Keine InterventionObservation protocol
Standard therapy offered until development of symptoms of heart failure decompensation occurs. Patients will be monitored until out of alert and at 30, 60, and 90 days.
Nicht zutreffend
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Number of participants with recovery from HeartLogic Alert
change in HeartLogic score to ≤ 6
by 30, 60, 90 days
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Number of participants with development of symptoms of heart failure decompensation
change from baseline or new development of, dyspnea, orthopnea, paroxysmal nocturnal dyspnea or edema
30, 60, 90 days
Number of participants with unintended office visit, emergency department visit, CHF admission
office visit, emergency department visit and/or CHF admission
30, 60, 90 days
Number of participants with Heart Failure Events (HFE)
1\) the patient was admitted or 2) the patient received 1 or more IV medications (including diuretic agents, inotropes, and vasodilators), or other parenteral therapy.
30, 60, 90 days
Teilnahme-Assistent
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
19 Years
Zugelassene Geschlechter
Alle

  • Boston Scientific device with HeartLogic enabled

  • Lack of standard contraindications to Sacubitril/valsartan:

    • history of ACE-inhibitor induced angioedema and in those with angiotensin II receptor blocker (ARB) therapy induced angioedema.
    • hypotension, hypovolemia
    • renal artery stenosis, renal failure
    • hyperkalemia
    • hepatic disease Child-Pugh class C
    • Pregnancy/Breast-feeding

  • Lack of standard contraindications to diuretic therapy

  • Systolic Blood Pressure > 105

  • Glomerular filtration rate <25 mL/min who are non-responsive to diuretic therapy or are on chronic renal dialysis
  • ongoing symptoms of heart failure decompensation (increased dyspnea and/or fatigue, for purposes of this study increased weight is not considered, see question 2 KCCQ).
  • recent significant change in arrhythmia burden (within the past 2 weeks)
  • in cardiac resynchronization therapy (CRT) patients, recent change (60 days) in effective delivery of CRT (eg. decreased biventricular paving %)
  • the subject is unable to sign or refuses to sign the patient informed consent
  • Symptomatic heart failure at rest or New York Heart Association Class IV at the time of enrollment
  • the subject is implanted with unipolar right atrial or right ventricular leads
  • subject has received or is scheduled to receive a heart transplant or ventricular assist device within the next 6 months
  • subject is pregnant or planning to become pregnant during the study
  • regularly scheduled IV heart failure therapy (e.g. inotropes or diuretics)
Heart Center Research, LLC logoHeart Center Research, LLC
Zentrale Studienkontakte
Kontakt: COO, 256-519-8472, [email protected]
1 Studienstandorte in 1 Ländern

Alabama

Heart Center Research, LLC, Huntsville, Alabama, 35801, United States
COO, Kontakt, 256-519-8472, [email protected]
Jay Dinerman, MD, Hauptprüfer
Offene Rekrutierung