Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06272734
Other study ID # RCV-0007
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 23, 2024
Est. completion date January 31, 2025

Study information

Verified date February 2024
Source Reprieve Cardiovascular, Inc
Contact Tony Fields
Phone +1-650-224-3884
Email tfields@reprievecardio.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of the study is to evaluate the use of the Reprieve System to decongest subjects with acute decompensated heart failure.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date January 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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, pulmonary vascular congestion on chest radiography) 2. =10 lb. (4.5 kg) above dry weight either by historical weights or as estimated by health care provider. 3. Patients = 18 years of age able to provide informed 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 protocol instructions or follow-up procedures. 9. Severe baseline 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. Enrollment in another interventional trial during the index hospitalization 11. Life expectancy less than 3 months 12. Women who are pregnant or intend to become pregnant.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Reprieve System
The Reprieve System is a hospital bedside fluid management console designed to provide personalized and automated infusion of the IV diuretic furosemide and physiological saline in response to the patient's real-time urine output to safely and rapidly decongest patients suffering from Acute Decompensated Heart Failure.

Locations

Country Name City State
Georgia Tbilisi Heart and Vascular Clinic Tbilisi

Sponsors (1)

Lead Sponsor Collaborator
Reprieve Cardiovascular, Inc

Country where clinical trial is conducted

Georgia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Functional Device Success Defined as the device's ability to perform its intended function as specified in the study protocol without any device-related adverse events or malfunctions as determined by the treating physician. Over the 72-hours maximum duration of therapy.
See also
  Status Clinical Trial Phase
Completed NCT04049045 - Effects of Empagliflozin on Diuresis and Renal Function in Patients With Acute Decompensated Heart Failure Phase 2
Active, not recruiting NCT05100836 - SURPASS Impella 5.5 Study
Recruiting NCT02898181 - Low Level Tragus Stimulation in Acute Decompensated Heart Failure N/A
Completed NCT02823626 - High-dose Aldosterone Antagonist for Acute Decompensated Heart Failure
Completed NCT02196038 - A Trial of Rehabilitation Therapy in Older Acute Heart Failure Patients N/A
Completed NCT02248831 - Evaluation of Cardiopulmonary Diseases by Ultrasound N/A
Completed NCT00693745 - Neutrophil Gelatinase-Associated Lipcalin (NGAL) Evaluation Along With B-Type Natriuretic Peptide in Acutely Decompensated HF N/A
Not yet recruiting NCT04391231 - HEMolysis in a Percutaneous Axial Flow LVAD, Effects of Pentoxifylline in a Randomized Controlled Trial Phase 4
Recruiting NCT05206422 - DORAYA-HF Early Feasibility Study N/A
Recruiting NCT01960218 - Gas Exchange for Predicting Hospital Heart Failure Readmissions N/A
Terminated NCT00904488 - Oral Metolazone and Intermittent Intravenous Furosemide Versus Continuous Infusion Furosemide in Acute Heart Failure Phase 4
Terminated NCT02620384 - Metolazone As Early Add On Therapy For Acute Decompensated Heart Failure (MELT-HF)--A Single Center Pilot Study. Phase 3
Completed NCT04318093 - Study of the Safety of BMS-986259 in Participants With Post-Acute Decompensated Heart Failure Phase 2
Recruiting NCT06161649 - Mobile Education System to Improve Disease Knowledge, Self-efficacy and Quality of Life in Patients With Heart Failure N/A
Completed NCT02289508 - Role of USCOM in Adult Patients With Heart Failure N/A
Terminated NCT01457053 - Assessment of Coronary Flow Reserve in Heart Failure Patients After Ultrafiltration Versus Diuretics N/A
Completed NCT04877652 - DR REGISTRY: Prospective Observational Study of ADHF Patients With Insufficient Response to Diuretics
Completed NCT03505788 - Acetazolamide in Decompensated Heart Failure With Volume OveRload (ADVOR) Phase 4
Completed NCT03146754 - A Study to Evaluate Lung Ultrasound as a Method to Measure Changes in Extravascular Lung Water Induced by Positional Changes (LUPE) N/A
Not yet recruiting NCT06414759 - Efficacy and Safety of Combination Diuretic Therapy in Patients With Acute Decompensated Heart Failure and Volume Overload Phase 4