Safety & Feasibility of DSR TherApy in Heart FAiluRe pAtients With Persistent Congestion

NCT04882358 | Unknown DMC

• 1 other identifier: 2019-CHF-006
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

Feasibility and safety study of the alfapump DSR system in the treatment of volume overloaded heart failure subjects receiving high doses of loop diuretics. Up to 24 subjects will be enrolled in up to 3 centres in Republic of Georgia, and randomized into 2 parallel treatment arms. Once implanted with the alfapump DSR system they will undergo DSR therapy in 2 phases: intensive treatment phase followed by maintenance treatment phase.

Conditions

Heart Failure; Volume Overload

Keywords

sodium; alfapump; direct sodium removal; diuretic resistance

Outcome Measures

Primary Outcomes (3)

• Safety - Treatment related SAE

  Rate of treatment related serious adverse events

  up to day 156

• Safety - Device related SAE

  Rate of Device related serious adverse events

  up to day 156

• Safety - Procedure related SAE

  Rate of Procedure related serious adverse events

  up to day 156

Secondary Outcomes (16)

• Safety - Treatment related

  day 14

• Safety - Treatment related

  day 128

• Safety - Treatment related

  up to day 156

• Safety - Device related

  day 14

• Safety - Device related

  day 128

Other Outcomes (34)

• Euvolemic state

  day 14

• Euvolemic state

  day 128

• Restart PRN Loop diuretic treatment

  up to day 156

Study Arms (2)

GROUP 1 DIRECT SODIUM REMOVAL + SGLT-2 INHIBITOR

EXPERIMENTAL

SUBJECTS TREATED WITH DSR + STANDARD DOSE OF APPROVED SGLT-2 INHIBITOR

Device: ALFAPUMP DSR (DIRECT SODIUM REMOVAL) SYSTEM; Drug: SGLT2 inhibitor

GROUP 2 DIRECT SODIUM REMOVAL

EXPERIMENTAL

SUBJECTS TREATED WITH DSR

Device: ALFAPUMP DSR (DIRECT SODIUM REMOVAL) SYSTEM

Interventions

ALFAPUMP DSR (DIRECT SODIUM REMOVAL) 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

GROUP 1 DIRECT SODIUM REMOVAL + SGLT-2 INHIBITOR; GROUP 2 DIRECT SODIUM REMOVAL

SGLT2 inhibitor DRUG

treatment with a standard dose of SGLT-2 inhibitor

Also known as: dapagliflozin

GROUP 1 DIRECT SODIUM REMOVAL + SGLT-2 INHIBITOR

Eligibility Criteria

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

You may qualify if:

• Subject is ≥18 years of age
• Subject has creatinine based eGFR (MDRD or CKD-EPI formula) \>30ml/min/1.73m²
• Subject is diagnosed with heart failure including the follow-ing:
• nt-proBNP \> 2000 pg/ml and oral diuretic dose \>80mg furosemide (or \>20mg torsemide or \>1mg bume-tanide)
• at least 1 hospitalization due to HF-related volume overload within the year prior to enrolment in the study
• at least 2 clinical signs and symptoms of volume over-load
• Subject has extravascular volume overload as evidenced by:
• Peripheral edema \> trace
• Known fluid weight gain, or physician estimate of ≥5kg of fluid overload;
• Subject has systolic blood pressure ≥ 100 mmHg
• Subject is able to tolerate surgical implantation of the alfapump using local standard of care anesthesia practices

You may not qualify if:

• Subject has proteinuria \> 1g/l as confirmed by dipstick (≥ +++)
• Subject presents an excessive subcutaneous fatty tissue layer at the intended location of alfapump implant, or with other characteristics which could interfere with implantation procedure or transcutaneous charging of the alfapump.
• Subject has anemia with hemoglobin \< 8g/dL
• Subject has serum sodium \< 135 mEq/L
• Subject has clinical signs of low output heart failure
• Subject has severe cardiac cachexia
• Subject has history of severe hyperkalemia or screening plasma potassium \> 4.5 mEq/L (K can be 4.5-5 meq/L if on 40meq or greater daily potassium supplementation and this can be stopped for the study).
• Subject has significant non-cardiac disease or comorbidities expected to reduce life expectancy to less than 1 year.
• Subject has cirrhosis or history of clinically significant ascites (i.e., prior large volume paracentesis) or large volume ascites on imaging or exam
• Subject has hemodynamically significant stenotic valvular disease
• Subject is receiving anti-coagulative or anti-platelet treatment which cannot be withheld for 5 days (replaced by bridging therapy low molecular weight heparin or unfractionated heparin) prior to and 2-3 days after alfapump DSR system implantation;
• Subject has suffered myocardial infarction (MI), cerebro-vascular accident (CVA) or transient ischemic attack (TIA) within 90 days prior to enrolment in the study
• Subject has history of peritonitis or history of abdominal surgery with increased risk of major abdominal adhesion as assessed by the investigator
• Subject has any active infection or history of recurrent urinary tract infection or history of current urosepsis
• Subject has history of renal transplant

Sponsors & Collaborators

• Sequana Medical N.V.: lead

Study Sites (2)

Israeli-Georgian Medical Research Clinic Helsicore

Tbilisi, 0112, Georgia

Location

Tbilisi Heart & Vascular Clinic

Tbilisi, 0159, 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; Edema

Interventions

Drug Delivery Systems; Sodium-Glucose Transporter 2 Inhibitors; dapagliflozin

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Study Officials

• TAMAZ SHABURISHVILI, MD

  TBILISI HEART & VASCULAR CLINIC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter, randomized, open label, feasibility and safety study

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: May 11, 2021
• Study Start: May 27, 2021
• Primary Completion: August 31, 2022
• Study Completion: December 31, 2024
• Last Updated: November 9, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

GE (2)