RecruitingNot applicable

Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II) (IDE-G210258)

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
22 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares the Reprieve System with standard water pill treatment to see which removes extra fluid more efficiently. It is for adults age 22 or older who are hospitalized with new or worsening heart failure and may not respond well to water pills.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have heart failure, expect to stay in the hospital over 24 hours, and receive or plan to receive heart failure treatment.
  • Have at least 2 new or worsening symptoms and at least 3 signs of heart failure found by exams or tests.
  • Weigh at least 10 pounds above your estimated weight without extra fluid.
  • Have a current prescription for a daily loop diuretic, a type of water pill.
  • Be age 22 or older, able to agree to join, and able to follow study steps.
  • Have signs that water pills may not work well: low blood chloride, low urine output, or low urine salt after a water pill given through a vein. Study tests must meet set limits.

Who can't join

  • Cannot safely have a Foley catheter, a tube that drains urine, because of placement problems or a high risk of injury or infection.
  • Have unstable blood flow: top blood pressure below 90 for over 15 minutes in the past 48 hours, recent medicines through a vein to support blood pressure or heart pumping, or heart-support machines within the past week. Also excluded: heart rate above 130 for over 10 minutes in the past 48 hours.
  • Have severe lung disease needing over 2 liters of home oxygen per minute, or an active infection affecting the body, such as an infection with fever.
  • Have a kidney filtering test result below 25 or need dialysis or another treatment that replaces kidney function.
  • Have serious heart blockage, narrowed valves, birth defects, or stiff heart muscle that makes rapid fluid removal unsafe; or had a heart attack from a ruptured artery plaque, heart bypass surgery, or stroke within 30 days.
  • Have severely low blood minerals at screening: potassium below 3.0, magnesium below 1.3, or sodium below 125. Correcting these levels does not allow another eligibility check.
  • Have another condition that could prevent following study steps or visits, need a long hospital stay for another reason, or are expected to live less than 6 months.
  • Are pregnant or breastfeeding, or are in another study that tests a treatment. Studies that only observe care are allowed.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 \<1L in the 6 hours following IV loop diuretic \>=40 mg furosemide equivalent OR Spot urine sodium \<100 mmol/L 1-2 hours after IV loop diuretic \>= 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 \<90 mmHg for \>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) \<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 (\< 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 \<3.0 mEq/L, magnesium \<1.3 mEq/L or sodium \<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.

Study sites (35)

CA

FL

GA

IL

KS

KY

MI

MN

MO

MS

NC

OH

OK

PA

SC

TN

TX

VA

WI