Management of Volume Overload HF Patients by Individual DSR Treatment adJustment-a clinicAl inVestigation of InfusatE2.0

Launched by SEQUANA MEDICAL N.V. · Jul 25, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with heart failure who struggle with excess fluid in their bodies, a condition known as volume overload. The researchers want to see if a special solution called Infusate 2.0 can help these patients feel better and manage their symptoms more effectively. The trial will involve several medical centers and will compare the new treatment to standard care. It is looking for participants who are at least 18 years old, have been diagnosed with heart failure, and have not responded to traditional diuretics (medications that help remove excess fluid).

Eligible participants will need to meet specific health criteria, such as having a certain level of kidney function and showing signs of excess fluid. If you join the study, you can expect regular check-ups and monitoring to track how well the treatment is working and to ensure your safety. It's also essential to know that participants will be required to use effective birth control if they are of childbearing potential. This study aims to provide new insights into managing heart failure, and those who participate could play a crucial role in advancing treatment options for others facing similar challenges.

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Eligibility criteria

• 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