Fluid management of Acute decompensated heart failure Subjects Treated with Reprieve Decongestion Management System (DMS) - FASTR Trial

Recruiting

• Conditions: Acute decompensated heart failure; heart failure; 10019280

• Registration Number: NL-OMON56708
• Lead Sponsor: Reprieve Cardiovascular, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

1. Hospitalized with a diagnosis of heart failure as defined by the presence of
at least 1 symptom (dyspnea, orthopnea, or edema/swelling) AND 1 sign
(peripheral edema, ascites, jugular venous distension).
2. >=10 lb (4.5 kg) above dry weight either by historical weights or as
estimated by health care provider.
3. Prior use of outpatient oral loop diuretics within 30 days prior to
admission.
4. Patients >= 18 years of age able to provide informed consent (or deferred
consent) and comply with study procedures.

Exclusion Criteria

1. Inability to place Foley catheter or IV catheter or other urologic issues
that would predispose the patient to a high rate of urogenital trauma or
infection with catheter placement.
2. Hemodynamic instability as defined by any of the following: systolic blood
pressure <90 mmHg, use of vasopressors, use of IV inotropes to treat
hypotension (systolic blood pressure <90 mm Hg) or suspected/confirmed low
cardiac output/shock, mechanical circulatory support, uncontrolled arrhythmias,
active severe bleeding, or confirmed or suspected cardiogenic shock. Note: In
the absence of the above conditions, use of inotropes to augment diuresis is
permitted.
3. Dyspnea due primarily to non-cardiac causes (e.g., severe chronic
obstructive pulmonary disease or pneumonia).
4. Acute infection with evidence of systemic involvement (e.g., clinically
suspected infection with fever or elevated serum white blood cell count).
5. Estimated glomerular filtration rate (eGFR) < 20 ml/min/1.73m2 calculated
using the MDRD equation or current use of renal replacement therapy (RRT).
6. Significant left ventricular outflow obstruction, uncorrected complex
congenital heart disease, known severe stenotic valvular disease, infiltrative
or constrictive cardiomyopathy, acute myocarditis, type 1 acute myocardial
infarction requiring treatment (within previous week), or any other pathology
that, in the opinion of the investigator, would make aggressive diuresis poorly
tolerated.
7. Inability to follow instructions or comply with follow-up procedures.
8. Other concomitant disease or condition that investigator deems unsuitable
for the study, including drug or alcohol abuse or psychiatric, behavioral or
cognitive disorders, sufficient to interfere with the patient*s ability to
understand and comply with the study instructions or follow-up procedures.
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. Subjects whose electrolyte levels are repleted cannot
be reassessed for inclusion in the trial.
10. Presence of active COVID-19 infection.
11. Enrollment in another interventional trial during the trial participation.
12. Inability to return for follow-up study visits.
13. Life expectancy less than 3 months.
14. Women who are pregnant. Pregnancy must be ruled out and the patient must
make every effort not to become pregnant.

Study & Design

• Study Type: Interventional
• Study Design: Not specified