Volume Optimization Incorporating Negative Pressure Diuresis in Heart Failure (VOID-HF)

NCT04227977 | Completed DMC FDA Device

• 1 other identifier: VOID-HF
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 4

Brief Summary

The Cardiorenal Syndrome during Acute decompensated heart failure (ADHF) with persistent congestion despite high dose IV diuretic therapy is associated with remarkable morbidity, which can include the need for renal dialysis or ultrafiltration, an increased length of stay, and high mortality rates. The aims and purpose of this feasibility clinical research trial are: 1. to evaluate the safety profiles associated with performing negative pressure diuresis for the treatment of hypervolemia associated with the cardiorenal syndrome during ADHF with persistent congestion despite high dose IV diuretic therapy via the investigational JuxtaFlow® System, and 2. to evaluate the effectiveness of the investigational JuxtaFlow System in treatment of hypervolemia associated with ADHF.

Conditions

Cardiorenal Syndrome

Outcome Measures

Primary Outcomes (1)

• Device related adverse events

  The characterization of the type, frequency, severity, and device-relatedness of adverse events (AEs) associated with the placement, use, and removal of the JuxtaFlow System and a 28-day post-treatment follow up.

  28 days

Secondary Outcomes (3)

• Urine output

  24 hours

• Congestion

  24 hours

• Creatinine Clearance

  24 hours

Study Arms (1)

Treatment

EXPERIMENTAL

JuxtaFlow

Device: JuxtaFlow System

Interventions

JuxtaFlow System DEVICE

The JuxtaFlow System consists of proprietary ureteral catheters deployed endoscopically over the wire to deliver mild controlled negative pressure into the renal pelvis.

Treatment

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients ≥22 years of age
• Patients admitted with primary diagnosis of ADHF
• Persistent volume overload with venous congestion despite at least 24 hours of IV diuretic therapy, including either a single bolus ≥ 100 mg or continuous drip ≥ 10 mg/hour of furosemide equivalent, where:
• Volume overload defined by the presence of pulmonary edema, 2+ peripheral edema, or orthopnea
• Venous congestion defined by at least one of the following:
• i. Jugular venous pressure \> 10 cm on physical exam ii. Central venous pressure \> 10 mmHg iii. Pulmonary capillary wedge pressure \> 22 mmHg c) Evidence of low natriuretic response to high dose diuretic therapy defined by spot urine sodium \< 70 mmol
• Ability to have the JuxtaFlow® System catheters placed at bedside
• Anticipated to have an inpatient hospital admission that is ≥ 72 hours
• Patients that are willing and able to provide informed consent for this research trial, or if the patient is not able to provide consent due to their clinical condition, a legal guardian, spouse, or next of kin to the patient with medical power of attorney that is willing to provide consent for the patient's participation in this research trial
• Patients who agree to comply with the study procedures and specified evaluations

You may not qualify if:

• Females who are pregnant or nursing mothers
• Creatinine \> 3.0 mg/dL at admission to the hospital
• Systolic blood pressure \< 100 mmHg at the time of enrollment
• Clinical instability likely to require the addition of intravenous vasoactive drugs, vasodilators and/or inotropic agents.
• Alternative explanation for the renal impairment causing the persistent volume overload, such as obstructive nephropathy, contrast induced nephropathy, or acute tubular necrosis
• Any patient with an eGFR \< 15 ml/min or prior diagnosis of CKD 5
• Any patient presenting with hematuria as defined by urine dipstick reading of \> 1+ blood
• Any patient presenting with proteinuria as defined by urine dipstick reading of \> 3+ protein.
• Any patient that would not potentially benefit from this therapy in the opinion of the investigator
• Any patient with a current upper or lower urinary tract infection (tested during pre-screening)
• Any patient with a malignancy of the upper urinary tract
• Any patient who are currently experiencing unexplained/unexpected proteinuria as determined by the investigator
• Any patient with a current unrepaired ureteral avulsion as determined by the investigator
• Any patient that would require an MRI between enrollment and completion of the post-treatment baseline period
• Any secondary condition as determined by the investigator that would place the subject at an increased risk, or preclude the subject's full compliance with the study procedures, including injuries to the urinary organs and/or external genitals

Sponsors & Collaborators

• 3ive Labs: lead

Study Sites (4)

University of Florida

Gainesville, Florida, 32611, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Univ. of Texas Health

San Antonio, Texas, 78229, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Cardio-Renal Syndrome

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Heart Failure; Heart Diseases; Cardiovascular Diseases

Study Officials

• Wilson Tang, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Alex Parker, MD

  Univ. of Florida, Gainesville

  PRINCIPAL INVESTIGATOR

• Wayne Old, MD

  Sentara Norfolk General Hospital

  PRINCIPAL INVESTIGATOR

• Shweta Bansal, MD

  Univ. of Texas Health, San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2020
• First Posted: January 14, 2020
• Study Start: June 12, 2020
• Primary Completion: May 1, 2023
• Study Completion: October 20, 2023
• Last Updated: October 25, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)