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

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ClinicalTrials.gov Identifier: NCT04882358
Recruitment Status : Recruiting
First Posted : May 11, 2021
Last Update Posted : June 1, 2021
Sponsor:
Information provided by (Responsible Party):
Sequana Medical N.V.

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.

Condition or disease Intervention/treatment Phase
Heart Failure Volume Overload Device: ALFAPUMP DSR (DIRECT SODIUM REMOVAL) SYSTEM Drug: SGLT2 inhibitor Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicenter, randomized, open label, feasibility and safety study
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Alfapump® DSR Feasibility Study in Subjects With Persistent Congestion Due to Heart Failure, Resistant to Loop Diuretic Treatment
Actual Study Start Date : May 27, 2021
Estimated Primary Completion Date : November 30, 2022
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: GROUP 1 DIRECT SODIUM REMOVAL + SGLT-2 INHIBITOR
SUBJECTS TREATED WITH DSR + STANDARD DOSE OF APPROVED SGLT-2 INHIBITOR
Device: ALFAPUMP DSR (DIRECT SODIUM REMOVAL) 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

Drug: SGLT2 inhibitor
treatment with a standard dose of SGLT-2 inhibitor
Other Name: dapagliflozin

Experimental: GROUP 2 DIRECT SODIUM REMOVAL
SUBJECTS TREATED WITH DSR
Device: ALFAPUMP DSR (DIRECT SODIUM REMOVAL) 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




Primary Outcome Measures :
  1. Safety - Treatment related SAE [ Time Frame: up to day 156 ]
    Rate of treatment related serious adverse events

  2. Safety - Device related SAE [ Time Frame: up to day 156 ]
    Rate of Device related serious adverse events

  3. Safety - Procedure related SAE [ Time Frame: up to day 156 ]
    Rate of Procedure related serious adverse events


Secondary Outcome Measures :
  1. Safety - Treatment related [ Time Frame: day 14 ]
    Rate of treatment related serious adverse events

  2. Safety - Treatment related [ Time Frame: day 128 ]
    Rate of treatment related serious adverse events

  3. Safety - Treatment related [ Time Frame: up to day 156 ]
    Rate of treatment related serious adverse events

  4. Safety - Device related [ Time Frame: day 14 ]
    Rate of Device related serious adverse events

  5. Safety - Device related [ Time Frame: day 128 ]
    Rate of Device related serious adverse events

  6. Safety - Device related [ Time Frame: up to day 156 ]
    Rate of Device related serious adverse events

  7. Safety - Procedure related [ Time Frame: day 14 ]
    Rate of Procedure related serious adverse events

  8. Safety - Procedure related [ Time Frame: day 128 ]
    Rate of Procedure related serious adverse events

  9. Safety - Procedure related [ Time Frame: up to day 156 ]
    Rate of Procedure related serious adverse events

  10. Safety - Device Deficiencies [ Time Frame: day 14 ]
    Rate of device deficiencies

  11. Safety - Device Deficiencies [ Time Frame: day 128 ]
    Rate of device deficiencies

  12. Safety - Device Deficiencies [ Time Frame: up to day 156 ]
    Rate of device deficiencies

  13. Weight loss ≥ 5kgs [ Time Frame: day 14 ]
    % of subjects reaching weight loss of ≥ 5kgs

  14. Weight change [ Time Frame: day 14 ]
    Change in weight from baseline

  15. Weight change [ Time Frame: day 128 ]
    Change in weight from baseline

  16. Weight change [ Time Frame: up to day 156 ]
    Change in weight from baseline


Other Outcome Measures:
  1. Euvolemic state [ Time Frame: day 14 ]
    Time to reach euvolemic state

  2. Euvolemic state [ Time Frame: day 128 ]
    Time euvolemic state is maintained in maintenance period

  3. Restart PRN Loop diuretic treatment [ Time Frame: up to day 156 ]
    Time to restart of PRN loop diuretic treatment

  4. Restart Loop diuretic treatment [ Time Frame: up to day 156 ]
    Time to restart of systematic loop diuretic treatment after start of DSR treatment

  5. Time Loop diuretic treatment reaching dose [ Time Frame: up to day 156 ]
    Time to reach loop diuretic treatment dose ≥ loop diuretic dose prior to DSR treatment start

  6. Time increase Loop diuretic treatment [ Time Frame: up to day 156 ]
    Time to loop diuretic dose increase once on therapy

  7. Amount Loop diuretic treatment [ Time Frame: up to day 156 ]
    Total mg of loop diuretic administered

  8. Change Renal function - urea [ Time Frame: up to day 156 ]
    Change in renal function -urea from baseline through treatment

  9. Change Renal function - creatinin [ Time Frame: up to day 156 ]
    Change in renal function -creatinin from baseline through treatment

  10. Change Hemoconcentration markers - serum hematocrit [ Time Frame: up to day 156 ]
    Change in hemoconcentration markers (serum hematocrit) from baseline through treatment

  11. Change Hemoconcentration markers - serum hemoglobin [ Time Frame: up to day 156 ]
    Change in hemoconcentration markers (serum hemoglobin) from baseline through treatment

  12. Hemoconcentration markers - serum albumin [ Time Frame: up to day 156 ]
    Change in hemoconcentration markers (serum albumin) from baseline through treatment

  13. Change Hemoconcentration markers - total serum protein [ Time Frame: up to day 156 ]
    Change in hemoconcentration markers (total serum protein) from baseline through treatment

  14. Change N-Terminal Prohormone of Brain Natriuretic Peptide (nt-ProBNP) [ Time Frame: up to day 156 ]
    Change in nt-proBNP from basline through treatment

  15. Change Hemoglobin A1c [ Time Frame: day 128 ]
    Change in hemoglobin A1c

  16. DSR doses [ Time Frame: up to day 156 ]
    Number of DSR doses per week

  17. Amount of 10% Dextrose infusate [ Time Frame: up to day 156 ]
    Amount of 10% Dextrose infusate given

  18. DSR dose adjustments [ Time Frame: day 14 ]
    Number of DSR dose adjustments

  19. DSR dose adjustments [ Time Frame: day 128 ]
    Number of DSR dose adjustments

  20. Sodium [ Time Frame: up to day 156 ]
    Net sodium loss with each DSR treatment (8 hours of DSR exposure)

  21. Urine volume [ Time Frame: up to day 156 ]
    Net fluid loss with each DSR treatment (8 hours of DSR exposure)

  22. Change 6-hour diuretic challenge response [ Time Frame: day 14 ]
    Change in response to 6 hour diuretic challenge from baseline

  23. Change 6-hour diuretic challenge response [ Time Frame: day 128 ]
    Change in response to 6 hour diuretic challenge from baseline

  24. Change 6-hour diuretic challenge response [ Time Frame: up to day 156 ]
    Change in response to 6 hour diuretic challenge from baseline

  25. Change Plasma electrolytes - sodium [ Time Frame: up to day 156 ]
    Change in plasma electrolytes - Sodium from baseline

  26. Change Plasma electrolytes - potassium [ Time Frame: up to day 156 ]
    Change in plasma electrolytes - potassium from baseline

  27. Change Plasma electrolytes - magnesium [ Time Frame: up to day 156 ]
    Change in plasma electrolytes - magnesium from baseline

  28. Change Plasma electrolytes - calcium [ Time Frame: up to day 156 ]
    Change in plasma electrolytes - calcium from baseline

  29. Change Plasma electrolytes - phosphor [ Time Frame: up to day 156 ]
    Change in plasma electrolytes - phosphor from baseline

  30. DSR dwell time [ Time Frame: up to day 156 ]
    Dwell time per DSR treatment

  31. Change Bio-impedance vector analysis [ Time Frame: up to day 156 ]
    Change in Bio-impedance vector analysis

  32. Ultrafiltration [ Time Frame: up to day 156 ]
    Total ultrafiltration

  33. Volume [ Time Frame: up to day 156 ]
    Total volume removed

  34. Glucose [ Time Frame: up to day 156 ]
    Total glucose resorption during DSR treatment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is ≥18 years of age
  2. Subject has creatinine based eGFR (MDRD or CKD-EPI formula) >30ml/min/1.73m²
  3. Subject is diagnosed with heart failure including the follow-ing:

    1. nt-proBNP > 2000 pg/ml and oral diuretic dose >80mg furosemide (or >20mg torsemide or >1mg bume-tanide)
    2. at least 1 hospitalization due to HF-related volume overload within the year prior to enrolment in the study
    3. at least 2 clinical signs and symptoms of volume over-load
  4. Subject has extravascular volume overload as evidenced by:

    1. Peripheral edema > trace
    2. Known fluid weight gain, or physician estimate of ≥5kg of fluid overload;
  5. Subject has systolic blood pressure ≥ 100 mmHg
  6. Subject is able to tolerate surgical implantation of the alfapump using local standard of care anesthesia practices

Exclusion Criteria:

  1. Subject has proteinuria > 1g/l as confirmed by dipstick (≥ +++)
  2. 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.
  3. Subject has anemia with hemoglobin < 8g/dL
  4. Subject has serum sodium < 135 mEq/L
  5. Subject has clinical signs of low output heart failure
  6. Subject has severe cardiac cachexia
  7. 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).
  8. Subject has significant non-cardiac disease or comorbidities expected to reduce life expectancy to less than 1 year.
  9. Subject has cirrhosis or history of clinically significant ascites (i.e., prior large volume paracentesis) or large volume ascites on imaging or exam
  10. Subject has hemodynamically significant stenotic valvular disease
  11. 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;
  12. Subject has suffered myocardial infarction (MI), cerebro-vascular accident (CVA) or transient ischemic attack (TIA) within 90 days prior to enrolment in the study
  13. Subject has history of peritonitis or history of abdominal surgery with increased risk of major abdominal adhesion as assessed by the investigator
  14. Subject has any active infection or history of recurrent urinary tract infection or history of current urosepsis
  15. Subject has history of renal transplant
  16. Subject has history of significant bladder dysfunction expected to interfere with ability of subject to tolerate DSR pumping into bladder
  17. Subject has uncontrolled diabetes with frequent hyperglycemia or Type 1 diabetes
  18. Subject has urinary incontinence
  19. Subject has history of type 1 diabetes, diabetic ketoacidosis, "brittle" diabetes or frequent hypoglycemia or severe hypoglycemic episodes requiring emergent intervention (ER visit or EMS response, glucagon administration or forced oral carbs) in the last 6 months
  20. Subject is pregnant or is breastfeeding or intends to become pregnant during the study
  21. Subject has severe peripheral artery disease
  22. Subject has hypersensitivity to SGLT2 inhibitors
  23. Subject is currently participating in another clinical trial
  24. Subject is unable or unwilling to comply with all required study follow-up procedures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04882358


Contacts
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Contact: Danny Detiège, RN +32 9 292 8065 danny.detiege@sequanamedical.com
Contact: Oliver Goedje, MD +32 9 292 8065 oliver.goedje@sequanamedical.com

Locations
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Georgia
Israeli-Georgian Medical Research Clinic Helsicore Not yet recruiting
Tbilisi, Georgia, 0112
Contact: Mamuka Kobalava, MD         
Contact: Tamila Diasamidze, RN         
Principal Investigator: Mamuka Kobalava, MD         
Tbilisi Heart & Vascular Clinic Recruiting
Tbilisi, Georgia, 0159
Contact: Tamaz SHABURISHVILI, MD    +995599502244    tamaz_shaburishvili@yahoo.com   
Contact: TAMAR BIGVAVA, MD    +995598111355    tamri.bigvava@gmail.com   
Principal Investigator: Tamaz SHABURISHVILI, MD         
Sponsors and Collaborators
Sequana Medical N.V.
Investigators
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Principal Investigator: TAMAZ SHABURISHVILI, MD TBILISI HEART & VASCULAR CLINIC
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Responsible Party: Sequana Medical N.V.
ClinicalTrials.gov Identifier: NCT04882358    
Other Study ID Numbers: 2019-CHF-006
First Posted: May 11, 2021    Key Record Dates
Last Update Posted: June 1, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD data will be shared with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sequana Medical N.V.:
sodium
alfapump
direct sodium removal
diuretic resistance
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs