Recruiting

Phase 1

Phase 2

Infuse2.0Management of Volume Overload HF Patients by Individual DSR Treatment adJustment-a clinicAl inVestigation of InfusatE2.0

Sponsor:

Sequana Medical N.V.

Code:

NCT05965934

Conditions

Heart Failure

Volume Overload

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Direct Sodium Removal Infusate 2.0

Study Details

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

Conditions

Heart Failure

Volume Overload

Study ID

NCT05965934

Start date

Jul 7, 2023

Status verified date

Jul, 2023

Completion date

Jun 30, 2025

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

33 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Direct Sodium Removal (DSR) Infusate 2.0

Participants will receive a peritoneal dialysis catheter implant. DSR is to be started 14 days after catheter implantation (= D1) for a period of 4 weeks (D28) on top of optimized usual care for HF, while loop diuretic treatment is suspended. Participants then enter enter a 3 month safety follow-up period (D29-D120) until the end of study (D120).

no intervention: Optimized Usual Care for HF

IV loop diuretic treatment is to be started (or continued) after a 14 days observation period (= D1) and can be continued for up to 4 weeks (D28). Participants then enter enter a 3 month safety follow-up period (D29-D120) until the end of study (D120).

Interventions

Direct Sodium Removal Infusate 2.0

Direct Sodium Removal via peritoneal ultrafiltration using Infusate 2.0 (30% icodextrin, 10% dextrose). Patients (if not yet on SGLT-2 inhibitors) will receive SGLT-2 inhibitors.

Primary outcome measure

Adverse event rate through end of treatment period [ Time Frame: from Day 1 to day 28 (treatment period) ]
Serious adverse event rate through end of treatment period [ Time Frame: from Day 1 to day 28 (treatment period) ]

Central Contacts and Locations

Central contacts

Jeroen Capel

+41 444 03 55 12 Jeroen.capel@sequanamedical.com

Oliver Goedje

+32 9 292 80 65 oliver.goedje@sequanamedical.com

Locations

Yale University

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Jeffrey Turner, MD

203-785-2020 jeffrey.turner@yale.edu

More Information

Sponsor

Sequana Medical N.V.

Last update posted

Jul 28, 2023

Last verified

Jul, 2023

Keywords

Direct Sodium Removal

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sequana Medical N.V. on 2023-07-28.