Status:
UNKNOWN
Safety & Feasibility of DSR TherApy in Heart FAiluRe pAtients With Persistent Congestion
Lead Sponsor:
Sequana Medical N.V.
Conditions:
Heart Failure
Volume Overload
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Detailed Description
The feasibility trial will consist of a 24-subject randomized study in volume overloaded heart failure subjects receiving high dose of loop diuretics. Subjects providing consent for participating in t...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Subject has history of significant bladder dysfunction expected to interfere with ability of subject to tolerate DSR pumping into bladder
- Subject has uncontrolled diabetes with frequent hyperglycemia or Type 1 diabetes
- Subject has urinary incontinence
- 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
- Subject is pregnant or is breastfeeding or intends to become pregnant during the study
- Subject has severe peripheral artery disease
- Subject has hypersensitivity to SGLT2 inhibitors
- Subject is currently participating in another clinical trial
- Subject is unable or unwilling to comply with all required study follow-up procedures
Key Trial Info
Start Date :
May 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04882358
Start Date
May 27 2021
End Date
December 31 2024
Last Update
November 9 2022
Active Locations (2)
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1
Israeli-Georgian Medical Research Clinic Helsicore
Tbilisi, Georgia, 0112
2
Tbilisi Heart & Vascular Clinic
Tbilisi, Georgia, 0159