Alfapump Direct Sodium Removal (DSR) Feasibility Study

NCT04116034 | Completed DMC

• 1 other identifier: 2019-CHF-005
• Study Type: interventional
• Target: 8
• Locations: 2 countries
• Sites: 2

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.

Conditions

Heart Failure; Congestive Heart Failure; Cardiorenal Syndrome; Volume Overload; Sodium Excess; Sodium Disorder

Outcome Measures

Primary Outcomes (6)

• Safety in-hospital - Device related

  Rate of device related serious adverse events

  Through Day 14 of treatment period

• Safety in-hospital - therapy related

  Rate of therapy related serious adverse events

  Through Day 14 of treatment period

• Safety in-hospital - procedure related

  Rate of procedure related serious adverse events

  Through Day 14 of treatment period

• Safety during treatment period - device related

  Rate of device related serious adverse events

  through Day 42 of treatment period

• Safety during treatment period - procedure related

  Rate of procedure serious adverse events

  through Day 42 of treatment period

• Safety during treatment period - therapy related

  Rate of therapy related serious adverse events

  through Day 42 of treatment period

Secondary Outcomes (2)

• Feasibiity endpoint sodium balance in-hospital

  through Day 14 of DSR therapy

• Feasibility endpoint sodium balance during treatment period

  Through Day 42 of DSR Therapy

Other Outcomes (8)

• Bioimpedance

  At baseline, day 7, 14, and 42

• Hemoconcentration markers

  At baseline, day 7, 14, and 42

• N-Terminal Prohormone of Brain Natriuretic Peptide (nt-ProBNP)

  At baseline, day 7, 14, and 42

Study Arms (1)

DSR

EXPERIMENTAL

Up to 10 subjects will be treated with alfapump DSR system for a total treatment period of 59 days post-implantation

Device: alfapump DSR system

Interventions

alfapump DSR system DEVICE

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

DSR

Eligibility Criteria

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

You may qualify if:

• Subjects \> 18 years of age
• eGFR \> 30ml/min/14.73m2
• 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)
• Stable diuretic dose for 30 days
• Systolic blood pressure ≥ 100 mmHg
• Determined by treating provider to be at optimal volume status

You may not qualify if:

• Proteinuria \> 1g/day
• BMI \> 40
• History of abdominal surgery or peritonitis
• Anemia with hemoglobin \< 8g/dL
• Serum sodium \< 135 mEq/L
• Severe hyperkalemia or baseline plasma potassium \> 4.5 mEq/L
• Significant other organ disease or comorbidities
• Hospitalization within 90 days
• Cirrhosis
• Hemodynamically significant stenotic valvular disease
• Active or recurrent urinary tract infection or history of renal transplant
• History of significant bladder dysfunction expected to interfere with ability of subject to tolerate DSR pumping into bladder
• Uncontrolled diabetes with frequent hyperglycemia or Type 1 diabetes
• Subject is currently participating in another clinical trial
• Subject is unable to comply with all required study follow-up procedures

Sponsors & Collaborators

• Sequana Medical N.V.: lead
• Yale University: collaborator

Study Sites (2)

OLV Ziekenhuis

Aalst, 9300, Belgium

Location

Tbilisi Heart & Vascular Clinic

Tbilisi, Georgia

Location

Related Publications (1)

• Rao VS, Ivey-Miranda JB, Cox ZL, Moreno-Villagomez J, Ramos-Mastache D, Neville D, Balkcom N, Asher JL, Bellumkonda L, Bigvava T, Shaburishvili T, Bartunek J, Wilson FP, Finkelstein F, Maulion C, Turner JM, Testani JM. Serial direct sodium removal in patients with heart failure and diuretic resistance. Eur J Heart Fail. 2024 May;26(5):1215-1230. doi: 10.1002/ejhf.3196. Epub 2024 Mar 31.

  PMID: 38556717 DERIVED

MeSH Terms

Conditions

Heart Failure; Cardio-Renal Syndrome; Edema; Hypernatremia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jozef Bartunek, MD

  Onze Lieve Vrouw Hospital Aalst, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: up to 10 subjects will be enrolled to evaluate feasibility and safety of thealfapump DSR system

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: October 4, 2019
• Study Start: December 26, 2019
• Primary Completion: April 15, 2021
• Study Completion: April 15, 2021
• Last Updated: May 28, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

GE (1); BE (1)