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Alfapump Direct Sodium Removal (DSR) Feasibility Study (RED DESERT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04116034
Recruitment Status : Completed
First Posted : October 4, 2019
Last Update Posted : May 28, 2021
Sponsor:
Collaborator:
Yale University
Information provided by (Responsible Party):
Sequana Medical N.V.

Tracking Information
First Submitted Date  ICMJE October 1, 2019
First Posted Date  ICMJE October 4, 2019
Last Update Posted Date May 28, 2021
Actual Study Start Date  ICMJE December 26, 2019
Actual Primary Completion Date April 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2019)
  • Safety in-hospital - Device related [ Time Frame: Through Day 14 of treatment period ]
    Rate of device related serious adverse events
  • Safety in-hospital - therapy related [ Time Frame: Through Day 14 of treatment period ]
    Rate of therapy related serious adverse events
  • Safety in-hospital - procedure related [ Time Frame: Through Day 14 of treatment period ]
    Rate of procedure related serious adverse events
  • Safety during treatment period - device related [ Time Frame: through Day 42 of treatment period ]
    Rate of device related serious adverse events
  • Safety during treatment period - procedure related [ Time Frame: through Day 42 of treatment period ]
    Rate of procedure serious adverse events
  • Safety during treatment period - therapy related [ Time Frame: through Day 42 of treatment period ]
    Rate of therapy related serious adverse events
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2019)
  • Feasibiity endpoint sodium balance in-hospital [ Time Frame: through Day 14 of DSR therapy ]
    Number of patients with neutral sodium balance (sodium intake equal to sodium output) in the absence of diuretic therapy during hospitalization period
  • Feasibility endpoint sodium balance during treatment period [ Time Frame: Through Day 42 of DSR Therapy ]
    Number of patients with neutral sodium balance (sodium intake equal to sodium output) in the absence of diuretic therapy in a titrated schedule during treatment period
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 2, 2019)
  • Bioimpedance [ Time Frame: At baseline, day 7, 14, and 42 ]
    Change in bioimpedance from baseline through treatment
  • Hemoconcentration markers [ Time Frame: At baseline, day 7, 14, and 42 ]
    Change in hemoglobin versus hematocrit ratio from baseline through treatment
  • N-Terminal Prohormone of Brain Natriuretic Peptide (nt-ProBNP) [ Time Frame: At baseline, day 7, 14, and 42 ]
    Change in nt-proBNP from basline through treatment
  • Weight [ Time Frame: At baseline, day 7, 14, and 42 ]
    Change in Weight from baseline through treatment
  • Glycolated Hemoglobine (HbA1c) [ Time Frame: At baseline, day 7, 14, and 42 ]
    Changes in HBA1c from baseline through treatment
  • Sodium balance [ Time Frame: Up to day 42 ]
    Daily sodium balance
  • Fluid balance [ Time Frame: Up to day 42 ]
    Daily fluid balance
  • 6-hour diuretic response [ Time Frame: At baseline, day 14, day 42 ]
    Change in response to 6 hour diuretic challenge from baseline through treatment
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Alfapump Direct Sodium Removal (DSR) Feasibility Study
Official Title  ICMJE Alfapump DSR System in the Treatment of Diuretic Resistant Heart Failure Subjects
Brief Summary First in Human feasibility and sfafety study of the alfapump DSR system in the treatment of Heart failure subects resistant to diuretic therapy. Up to 10 subjects will be enrolled in up to 3 centres in Belgium and Georgia and will be iplanted with the alfapump DSR system. Subjects will undergo DSR titration during a 2 week hospitalisation period, and will continue titrated DSR therapy as outpatients for 4 more weeks.
Detailed Description

Up to 10 subjects diagnosed with stable chronic heart failure (CHF) on high oral diuretic dose and an MDRD eGFR > 30ml/min/1.73m2 will undergo subcutaneous implantation of the alfapump DSR system (Day-13) and portacath system and participate in a 6 week interventional study. Prior to an inpatient study period, the subject will undergo a 40mg IV furosemide (or 1 mg IV bumetanide) diuretic challenge with timed biospecimen collection. On day 14 post-implant (Day 0), the subject will be admitted for a 14-day period in which diuretics will be withheld and subjects will be on a strict low-sodium (3g/day) diet with strict intake/output and all urine collected and samples saved for analysis. During the first 7 days (Day 0 - 6) subjects will be treated with 1000ml of DSR Infusate Monday, Wednesday, Friday administered to the peritoneal cavity through the subcutaneous peritoneal catheter. The infusate will remain in the peritoneal cavity for a 2 hour dwell time, then all fluid will be removed from the peritoneal cavity to the urinary bladder using the alfapump DSR system over the subsequent 8 hours. On day 7, subjects will be transitioned to a moderate to high salt diet given as the same low-sodium (3g/day) diet with supplementation with sodium chloride tablets (2g/day) (5g/day total sodium), as this will likely represent their typical home sodium intake. During this time, the optimal treatment protocol (frequency of administration and volume of DSR infusate administered) for individual subjects based on daily sodium balance, weight changes, and blood pressure will be created and tested over the next seven days in hospital (Day 7 - 13). Following the inpatient period, a second diuretic challenge will be conducted. Over the subsequent 28 days, diuretics will continue to be withheld with preferential maintenance of euvolemia through DSR and subjects will come into the clinic based on their tailored therapy schedule and undergo supervised DSR infusate administration. Addition of diuretic treatment will only be allowed if maximal DSR therapy has been instituted (DSR 7 days per week (i.e., including weekends) at 1.5L per session with dwell time of 4 hours) and/or holding diuretics until additional DSR can be utilized would represent a risk to the subject, as described in the CIP diuretic algorithm.

After the completion of the study period, the alfapump DSR therapy is halted and the subject undergoes a third diuretic challenge to quantify diuretic response. At this point oral diuretic therapy will be resumed. At the end of the study the alfapump can remain implanted and set to 'dormant' state after discussion and agreement between subject and investigator, and if there are no clinical, ethical or other reasons indicating explanation of the alfapump. Alternatively, the subject may elect to enroll into a low intensity follow-on study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
up to 10 subjects will be enrolled to evaluate feasibility and safety of thealfapump DSR system
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE
  • Heart Failure
  • Congestive Heart Failure
  • Cardiorenal Syndrome
  • Volume Overload
  • Sodium Excess
  • Sodium Disorder
Intervention  ICMJE Device: alfapump DSR system
Infusion of sodium free Dextrose 10% into peritoneal cavity to remove sodium and fluid using principles of peritoneal dialysis, sodium and ultrafiltrate will be evacuated to the bladder by the alfapump
Study Arms  ICMJE Experimental: DSR
Up to 10 subjects will be treated with alfapump DSR system for a total treatment period of 59 days post-implantation
Intervention: Device: alfapump DSR system
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 27, 2021)
8
Original Estimated Enrollment  ICMJE
 (submitted: October 2, 2019)
10
Actual Study Completion Date  ICMJE April 15, 2021
Actual Primary Completion Date April 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subjects > 18 years of age
  2. eGFR > 30ml/min/14.73m2
  3. Diagnosis of heart failure with one of the following: a. nt-proBNP > 400 pg/ml (or BNP > 100 pg/mp) and oral diuretic dose ≥ 80mg furosemide (or 20mg torsemide or 1mg bumetanide) OR b. Oral diuretic dose ≥ 120mg furosemide (or 30 mg torsemide or 1.5 mg bumetanide)
  4. Stable diuretic dose for 30 days
  5. Systolic blood pressure ≥ 100 mmHg
  6. Determined by treating provider to be at optimal volume status

Exclusion Criteria:

Candidates for participation will be ineligible for the study if any of the following exclusion criteria apply:

  1. Proteinuria > 1g/day
  2. BMI > 40
  3. History of abdominal surgery or peritonitis
  4. Anemia with hemoglobin < 8g/dL
  5. Serum sodium < 135 mEq/L
  6. Severe hyperkalemia or baseline plasma potassium > 4.5 mEq/L
  7. Significant other organ disease or comorbidities
  8. Hospitalization within 90 days
  9. Cirrhosis
  10. Hemodynamically significant stenotic valvular disease
  11. Active or recurrent urinary tract infection or history of renal transplant
  12. History of significant bladder dysfunction expected to interfere with ability of subject to tolerate DSR pumping into bladder
  13. Uncontrolled diabetes with frequent hyperglycemia or Type 1 diabetes
  14. Subject is currently participating in another clinical trial
  15. Subject is unable to comply with all required study follow-up procedures
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Georgia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04116034
Other Study ID Numbers  ICMJE 2019-CHF-005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No IPD data will be shared with other researchers
Responsible Party Sequana Medical N.V.
Study Sponsor  ICMJE Sequana Medical N.V.
Collaborators  ICMJE Yale University
Investigators  ICMJE
Principal Investigator: Jozef Bartunek, MD Onze Lieve Vrouw Hospital Aalst, Belgium
PRS Account Sequana Medical N.V.
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP