Heart Failure Clinical Trial
— RED DESERTOfficial title:
Alfapump DSR System in the Treatment of Diuretic Resistant Heart Failure Subjects
Verified date | May 2021 |
Source | Sequana Medical N.V. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 8 |
Est. completion date | April 15, 2021 |
Est. primary completion date | April 15, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Subjects > 18 years of age 2. eGFR > 30ml/min/14.73m2 3. 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) 4. Stable diuretic dose for 30 days 5. Systolic blood pressure = 100 mmHg 6. Determined by treating provider to be at optimal volume status Exclusion Criteria: Candidates for participation will be ineligible for the study if any of the following exclusion criteria apply: 1. Proteinuria > 1g/day 2. BMI > 40 3. History of abdominal surgery or peritonitis 4. Anemia with hemoglobin < 8g/dL 5. Serum sodium < 135 mEq/L 6. Severe hyperkalemia or baseline plasma potassium > 4.5 mEq/L 7. Significant other organ disease or comorbidities 8. Hospitalization within 90 days 9. Cirrhosis 10. Hemodynamically significant stenotic valvular disease 11. Active or recurrent urinary tract infection or history of renal transplant 12. History of significant bladder dysfunction expected to interfere with ability of subject to tolerate DSR pumping into bladder 13. Uncontrolled diabetes with frequent hyperglycemia or Type 1 diabetes 14. Subject is currently participating in another clinical trial 15. Subject is unable to comply with all required study follow-up procedures |
Country | Name | City | State |
---|---|---|---|
Belgium | OLV Ziekenhuis | Aalst | |
Georgia | Tbilisi Heart & Vascular Clinic | Tbilisi |
Lead Sponsor | Collaborator |
---|---|
Sequana Medical N.V. | Yale University |
Belgium, Georgia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Bioimpedance | Change in bioimpedance from baseline through treatment | At baseline, day 7, 14, and 42 | |
Other | Hemoconcentration markers | Change in hemoglobin versus hematocrit ratio from baseline through treatment | At baseline, day 7, 14, and 42 | |
Other | N-Terminal Prohormone of Brain Natriuretic Peptide (nt-ProBNP) | Change in nt-proBNP from basline through treatment | At baseline, day 7, 14, and 42 | |
Other | Weight | Change in Weight from baseline through treatment | At baseline, day 7, 14, and 42 | |
Other | Glycolated Hemoglobine (HbA1c) | Changes in HBA1c from baseline through treatment | At baseline, day 7, 14, and 42 | |
Other | Sodium balance | Daily sodium balance | Up to day 42 | |
Other | Fluid balance | Daily fluid balance | Up to day 42 | |
Other | 6-hour diuretic response | Change in response to 6 hour diuretic challenge from baseline through treatment | At baseline, day 14, day 42 | |
Primary | Safety in-hospital - Device related | Rate of device related serious adverse events | Through Day 14 of treatment period | |
Primary | Safety in-hospital - therapy related | Rate of therapy related serious adverse events | Through Day 14 of treatment period | |
Primary | Safety in-hospital - procedure related | Rate of procedure related serious adverse events | Through Day 14 of treatment period | |
Primary | Safety during treatment period - device related | Rate of device related serious adverse events | through Day 42 of treatment period | |
Primary | Safety during treatment period - procedure related | Rate of procedure serious adverse events | through Day 42 of treatment period | |
Primary | Safety during treatment period - therapy related | Rate of therapy related serious adverse events | through Day 42 of treatment period | |
Secondary | Feasibiity endpoint sodium balance in-hospital | Number of patients with neutral sodium balance (sodium intake equal to sodium output) in the absence of diuretic therapy during hospitalization period | through Day 14 of DSR therapy | |
Secondary | Feasibility endpoint sodium balance during treatment period | Number of patients with neutral sodium balance (sodium intake equal to sodium output) in the absence of diuretic therapy in a titrated schedule during treatment period | Through Day 42 of DSR Therapy |
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