Reprieve System Pilot Study

Acute Decompensated Heart Failure Clinical Trial

Official title:

Reprieve System for the Treatment of Subjects With Acute Decompensated Heart Failure Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06272734
• Other study ID #: RCV-0007
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Acute Decompensated Heart Failure
• Heart Failure

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.