Status:
UNKNOWN
Management of Volume Overload HF Patients by Individual DSR Treatment adJustment-a clinicAl inVestigation of InfusatE2.0
Lead Sponsor:
Sequana Medical N.V.
Conditions:
Heart Failure
Volume Overload
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This study is a multi-center, prospective, randomized (2:1), open-label study to evaluate the safety and efficacy of DSR therapy using the Infusate 2.0 peritoneal solution (composed of 30% icodextrin ...
Detailed Description
The study will start with a non-randomized cohort in which 3 eligible subjects will be treated with Infusate 2.0 on top of their usual care while all loop diuretic treatment is stopped. A Peritoneal D...
Eligibility Criteria
Inclusion
- Aged ≥18 years at screening
- Weight at screening ≥50 kg (110 lbs)
- Creatinine-based estimated glomerular filtration rate (eGFR) (CKD-EPI\] 2021 formula) ≥30 mL/min/1.73m² at screening
- 6-hour cumulative urine sodium excretion \<100 mmol to 40 mg IV furosemide on diuretic challenge
- Diagnosis of symptomatic heart failure with NYHA class III or IV AND daily diuretic dose ≥80 mg furosemide (or ≥20 mg torsemide or ≥1 mg bumetanide) for ≥14 days prior to screening AND NT-proBNP \>2000 pg/mL (or BNP \>400 pg/mL) OR oral daily diuretic dose ≥160 mg furosemide (or ≥40 mg torsemide or ≥2 mg bumetanide) over the previous 14 days AND ≥2 HF volume overload events within the last 6 months prior to screening or 2 HF volume overload-related hospitalizations within the last 12 months prior to screening
- Persistent mild to moderate volume overload with ≥2,3 kg (5 lbs) of excess hypervolemia AND more than trace peripheral edema AND/OR jugular venous distention AND/OR elevated filling pressure on chronic remote pressure monitoring device
- Systolic blood pressure ≥90 mmHg and \<180 mmHg
- Receiving maximally tolerated stable doses of guideline-directed medical therapy (GDMT)
- For participants of childbearing potential: negative pregnancy test and agreement to use highly effective contraception for ≥1 month prior to screening and until ≥3 months after last exposure to investigational medicinal product
- For participants with intimate partners of childbearing potential: agreement to use highly effective contraception for ≥1 month prior to screening and until ≥3 months after last exposure to investigational medicinal product
Exclusion
- Reversible cause of persistent decompensation or diuretic resistance
- Contraindications for peritoneal dialysis (PD) or PD catheter placement
- Known contraindication to icodextrin use
- Known contraindication or intolerance or allergy to SGLT2 inhibitors
- Current diagnosis of severe bladder dysfunction
- Imminent need for hospitalization
- Current or prior (past 6 months) use of renal replacement therapy
- Anemia with hemoglobin \<8 g/dL
- Serum sodium \<130 mEq/L
- Severe albuminuria (urinary albumin/creatinine ratio \>1 at screening)
- Severe cardiac cachexia
- Clinically significant cirrhosis or history of clinically significant ascites (i.e., prior large volume paracentesis) or large volume ascites on imaging or exam
- Type 1 diabetes, uncontrolled Type 2 diabetes, "brittle" diabetes or frequent hypoglycemia or severe hyperglycemic episodes requiring emergent intervention in the last 6 months
- Known or suspected low output HF
- Prior or planned heart transplant or mechanical cardiac support implantation (LVAD)
- History of severe hyperkalemia \> 5.5 mEq/L (past 6 months) or screening plasma potassium \>4.5 mEq/L
- Significant non-cardiac disease or comorbidities expected to reduce life expectancy to \<1 year or to interfere with safety or conduct of the study
- Severe restrictive or obstructive HF or hemodynamically significant, severe uncorrected stenotic valvular disease
- Receiving anticoagulation or antiplatelet treatment, which cannot be withheld (bridging therapy allowed)
- Recent myocardial infarction, cerebrovascular accident, transient ischemic attack, coronary revascularization, arrhythmia ablation, cardiac resynchronization therapy, or surgical or transcatheter valve intervention (within 90 days prior to screening)
- Received treatment with other investigational products or devices within 30 days of screening or 5 halflives of the previous investigational product
- Pregnancy or lactation
Key Trial Info
Start Date :
July 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT05965934
Start Date
July 7 2023
End Date
June 30 2025
Last Update
July 28 2023
Active Locations (1)
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1
Yale University
New Haven, Connecticut, United States, 06510