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Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-I

UCI Specialty Area: Cardiology
Principal Investigator: Alpesh Amin
Official Title: Fluid management of Acute decompensated heart failure Subjects Treated with Reprieve Decongestion Management System II - FASTR II Trial
A Study On:
Heart - Cardiovascular Circulatory
Heart Failure

Study Description

Eligibility

  1. Diagnosis of HF with expected hospitalization greater than 24 hours, with greater than 1 new or worsening symptom and greater than 2 physical examination, laboratory, or invasive findings of HF, and receiving or with plans to receive a HF-specific treatment
  2. Greater than or equal to 10 lb. (4.5 kg) above dry weight as estimated by health care provider.
  3. Current outpatient prescription for daily loop diuretic.
  4. Participants greater than or equal to 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 less than 1L in the 6 hours following IV loop diuretic greater than or equal to 40 mg furosemide equivalent OR Spot urine sodium less than 100 mmol/L 1-2 hours after IV loop diuretic greater than or equal to 40 mg furosemide equivalent
  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 less than 90 mmHg for greater than 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 greater than 130 beats/min for greater than 10 minutes within the past 48 hours.
  4. Severe lung disease with chronic home oxygen requirement greater than 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) less than 25 ml/min/1.73m2 (calculated with either MDRD or CKD-EPI) or current use of renal replacement therapy (RRT).
  7. Significant left ventricular outflow obstruction, severe uncorrected complex congenital heart disease, known severe stenotic valvular disease, severe infiltrative or constrictive cardiomyopathy or other diagnosis that would make aggressive decongestion unsafe.
  8. Current or recent (less than 30 days) type I myocardial infarction (e.g., acute coronary syndrome such as NSTEMI or STEMI from plaque rupture), coronary artery bypass surgery, or stroke. An isolated troponin elevation (e.g., from volume overload or demand ischemia) is not a reason for exclusion.
  9. Severe electrolyte abnormalities (e.g., serum potassium less than 3.0 mEq/L, magnesium less than 1.3 mEq/L or sodium less than 125 mEq/L). Note: These are based on baseline/screening labs. Participants whose electrolyte levels are repleted cannot be reassessed for inclusion in the trial.
  10. Other concomitant disease or condition the investigator believes will make it difficult to follow instructions or comply with study procedures and/or follow-up visits, including expected prolonged hospitalization for reasons other than decongestive therapy
  11. Currently enrolled in an interventional trial (observational studies are permitted).
  12. Life expectancy less than 6 months.
  13. Women who are pregnant or breastfeeding.
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Privacy Policy

University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

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