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FASTR II

  • Status
    Accepting Candidates
  • Age
    22 Years - N/A
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

The objective of this study is to prospectively compare decongestive therapy administered by the Reprieve System to Optimal Diuretic Therapy (ODT) in the treatment of patients diagnosed with acute decompensated heart failure (ADHF). The main objective is to determine if the Reprieve System can more efficiently decongest ADHF patients in comparison to Control Therapy.

Details

Full study title Fluid Management of Acute decompensated heart failure Subjects Treated with Reprieve System-FASTR II
Protocol number OCR47947
ClinicalTrials.gov ID NCT06898515
Phase Phase 3

Eligibility

Inclusion Criteria:

  1. Diagnosis of HF with expected hospitalization >24 hours, with >1 new or worsening symptom and >2 physical examination, laboratory, or invasive findings of HF, and receiving or with plans to receive a HF-specific treatment

  2. ≥10 lb. (4. 5 kg) above dry weight as estimated by health care provider.

  3. Current outpatient prescription for daily loop diuretic.

  4. Participants ≥ 22 years of age able to provide informed consent and comply with study procedures.

  5. Elevated risk of diuretic resistance, as indicated by at least one of the following: Baseline hypochloremia OR Urine output =40 mg furosemide equivalent OR Spot urine sodium = 40 mg furosemide equivalent

Exclusion Criteria:

  1. Urologic issues that would predispose the participant to a high rate of urogenital trauma or infection with catheter placement or known inability to place a Foley catheter.

  2. Hemodynamic instability as defined by any of the following: sustained systolic blood pressure 15 minutes within the past 48 hours, use of IV vasopressors or inotropes within past 48 hours, and/or current or previous mechanical circulatory support within the last week.

  3. Uncontrolled arrhythmias defined as sustained HR >130 beats/min for >10 minutes within the past 48 hours.

  4. Severe lung disease with chronic home oxygen requirement >2L/min.

  5. Acute infection with evidence of systemic involvement (e.g., clinically suspected infection with fever or elevated serum white blood cell count).

  6. Estimated glomerular filtration rate (eGFR)

Lead researcher

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  1. Step
    1

    Contact the research team

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  2. Step
    2

    Get screened to confirm eligibility

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  3. Step
    3

    Provide your consent to participate

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  4. Step
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    Participate

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