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

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sequana Medical N.V.
• Treatments: 2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol; Dapagliflozin; Sodium-Glucose Transporter 2 Inhibitors

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