A Prospective, Randomized Study of Infusate 2.0 Direct Sodium Removal (DSR) Treatment in Subjects With Chronic Heart Failure (CHF) Induced Persistent Congestion, Resistant to Loop Diuretic Treatment.

2022-CHF-012

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 and 10% dextrose) in diuretic resistant patients with HF and persistent volume overload.

2023-07-07

2024-12-31

2025-06-30

Recruiting

Early phase I

33

Inclusion Criteria: * 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 Criteria: * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 33, 'type': 'ESTIMATED'}}

2023-07-28