Phase
Condition
Chest Pain
Heart Failure
Congestive Heart Failure
Treatment
Reprieve System
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Hospitalized with a diagnosis of heart failure as defined by the presence of atleast 1 symptom (dyspnea, orthopnea, or edema/swelling) AND 1 sign (peripheraledema, ascites, jugular venous distension, pulmonary vascular congestion on chestradiography)
≥10 lb. (4.5 kg) above dry weight either by historical weights or as estimated byhealth care provider.
Patients ≥ 18 years of age able to provide informed consent and comply with studyprocedures.
Exclusion
Exclusion Criteria:
Inability to place Foley catheter or IV catheter or other urologic issues that wouldpredispose the patient to a high rate of urogenital trauma or infection withcatheter placement.
Hemodynamic instability as defined by any of the following: systolic blood pressure <90 mmHg, use of vasopressors, use of IV inotropes to treat hypotension (systolicblood pressure <90 mm Hg) or suspected/confirmed low cardiac output/shock,mechanical circulatory support, uncontrolled arrhythmias, active severe bleeding, orconfirmed or suspected cardiogenic shock. Note: In the absence of the aboveconditions, use of inotropes to augment diuresis is permitted.
Dyspnea due primarily to non-cardiac causes (e.g., severe chronic obstructivepulmonary disease or pneumonia).
Acute infection with evidence of systemic involvement (e.g., clinically suspectedinfection with fever or elevated serum white blood cell count).
Estimated glomerular filtration rate (eGFR) < 20 ml/min/1.73m2 calculated using theMDRD equation or current use of renal replacement therapy (RRT).
Significant left ventricular outflow obstruction, uncorrected complex congenitalheart disease, known severe stenotic valvular disease, infiltrative or constrictivecardiomyopathy, acute myocarditis, type 1 acute myocardial infarction requiringtreatment (within previous week), or any other pathology that, in the opinion of theinvestigator, would make aggressive diuresis poorly tolerated.
Inability to follow instructions or comply with follow-up procedures.
Other concomitant disease or condition that investigator deems unsuitable for thestudy, including drug or alcohol abuse or psychiatric, behavioral, or cognitivedisorders, sufficient to interfere with the patient's ability to understand andcomply with the protocol instructions or follow-up procedures.
Severe baseline electrolyte abnormalities (e.g., serum potassium <3.0 mEq/L ormagnesium <1.3 mEq/L). Note: These are based on baseline/screening labs. Subjectswhose electrolyte levels are repleted cannot be reassessed for inclusion in thetrial.
Serum sodium <135 mmol/L or history of severe hyponatremia
Poorly controlled diabetes
Enrollment in another interventional trial during the index hospitalization
Life expectancy less than 3 months
Women who are pregnant or intend to become pregnant.
Study Design
Connect with a study center
Tbilisi Heart and Vascular Clinic
Tbilisi, 0159
GeorgiaActive - Recruiting
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