Subcutaneous Furosemide in Acute Decompensated Heart Failure: The SUBQ-HF Study

Overview

Información sobre este estudio

To determine if a strategy of early discharge using a novel subcutaneous delivery system for parenteral furosemide can improve clinical outcomes within 30 days of randomization (days alive and outside the hospital) compared to usual care.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  1. Age >18 years
  2. Willingness and ability to provide informed consent
  3. Hospitalization for AHF with at least 1 symptom (dyspnea, orthopnea, or edema) AND 1 sign (rales on auscultation, peripheral edema, ascites, pulmonary vascular congestion on chest radiography, BNP > 250 ng/mL or NTproBNP > 1000 ng/mL) of congestion
  4. Persistent congestion despite at least 18 hours of IV therapy, defined by the presence of at least 2 or more of the following at the time of consent:
    1. Peripheral edema
    2. Rales
    3. Elevated JVP
    4. Ascites
    5. BNP > 250 ng/mL or NTproBNP > 1000 ng/mL
  5. Total anticipated daily IV furosemide dose (at time of screening) >80-200mg (or equivalent)/day
  6. Anticipated need for at least 24 more hours of parenteral diuretic therapy

Exclusion Criteria:

  1. Severe renal dysfunction (eGFR< 30 ml/min/1.73m2)
  2. Requirement for inotropes (other than digoxin) or mechanical support during hospitalization
  3. Clinically significant electrical instability during hospitalization
  4. Ongoing need for other intravenous therapies beyond diuretics (vasodilators, antibiotics, etc.)
  5. Anticipated need for ongoing parenteral electrolyte repletion
  6. Planned discharge to location other than home (e.g., hospice, skilled nursing facility, etc.)
  7. Anticipated cardiac transplantation or left ventricular assist device within the next 30 days
  8. Primary hypertrophic cardiomyopathy, infiltrative cardiomyopathy, acute myocarditis, constrictive pericarditis or tamponade
  9. Known or anticipated pregnancy in the next 30 days
  10. Prior use of a subcutaneous furosemide pump or current use of any subcutaneous pump, on-body infusion devices or patients who give regimented injections at the intended site of the sc2Wear on body infusion pump
  11. Other psychosocial or physical barriers to following the protocol and using SQ pump device outside the hospital setting
  12. Known allergy to furosemide
  13. Known sensitivity or allergy to medical adhesive tape

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Margaret Redfield, M.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available
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CLS-20347335

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