RECRUITING

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

Conditions

Heart Failure Volume Overload Direct Sodium Removal

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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.

Quick Facts

Study Start:2023-07-07

Study Completion:2025-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05965934

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Jeroen Capel

CONTACT

+41 444 03 55 12

Jeroen.capel@sequanamedical.com

Oliver Goedje

CONTACT

+32 9 292 80 65

oliver.goedje@sequanamedical.com

Principal Investigator

Jeffrey Turner, MD

PRINCIPAL_INVESTIGATOR

Yale Universtiry

Marath Fudim, MD MHS

PRINCIPAL_INVESTIGATOR

Duke University

Study Locations (Sites)

Yale University

New Haven, Connecticut, 06510

United States

Collaborators and Investigators

Sponsor: Sequana Medical N.V.

Jeffrey Turner, MD, PRINCIPAL_INVESTIGATOR, Yale Universtiry
Marath Fudim, MD MHS, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-07

Study Completion Date2025-06-30

Study Record Updates

Study Start Date2023-07-07

Study Completion Date2025-06-30

Terms related to this study

Keywords Provided by Researchers

Direct Sodium Removal

Additional Relevant MeSH Terms

Heart Failure
Volume Overload