Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-27 @ 10:47 PM
Study NCT ID:
NCT05965934
Status:
UNKNOWN
Last Update Posted:
2023-07-28
First Post:
2023-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Management of Volume Overload HF Patients by Individual DSR Treatment adJustment-a clinicAl inVestigation of InfusatE2.0
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D004487', 'term': 'Edema'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077203', 'term': 'Sodium-Glucose Transporter 2 Inhibitors'}, {'id': 'C529054', 'term': 'dapagliflozin'}], 'ancestors': [{'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D007004', 'term': 'Hypoglycemic Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 33}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-25', 'studyFirstSubmitDate': '2023-07-13', 'studyFirstSubmitQcDate': '2023-07-25', 'lastUpdatePostDateStruct': {'date': '2023-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse event rate through end of treatment period', 'timeFrame': 'from Day 1 to day 28 (treatment period)', 'description': 'Safety'}, {'measure': 'Serious adverse event rate through end of treatment period', 'timeFrame': 'from Day 1 to day 28 (treatment period)', 'description': 'Safety'}], 'secondaryOutcomes': [{'measure': 'Change in Urine sodium output from baseline to end of treatment period', 'timeFrame': 'from Day 1 to day 28 (treatment period)', 'description': 'Efficacy'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Direct Sodium Removal'], 'conditions': ['Heart Failure', 'Volume Overload']}, 'referencesModule': {'references': [{'pmid': '38273436', 'type': 'DERIVED', 'citation': 'McIntyre CW. Update on Hemodialysis-Induced Multiorgan Ischemia: Brains and Beyond. J Am Soc Nephrol. 2024 May 1;35(5):653-664. doi: 10.1681/ASN.0000000000000299. Epub 2024 Jan 26.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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 Dialysis (PD) catheter will be implanted to administer the infusate 14 days post-PD catheter implantation. The infusate will be drained via the same route after up to 24 hr dwell time. This DSR process will be repeated up to daily over a treatment period of 4 weeks (D1-D28). The quantity of infusate and the duration of dwell time will be adjusted based on treatment effect and tolerability.\n\nAfter the treatment period, the PD catheter is removed and a 3 month safety follow-up period starts to the end of study (D29-D120).\n\nAfter Data and Safety Monitoring Board (DSMB) review of 30 days follow-up data (D58) of the non-randomized cohort and DSMB approval to proceed, the 2:1 randomized enrollment of up to 30 additional subjects will be opened.\n\n* DSR Group (N = 20) Treatment: DSR Infusate 2.0 DSR is to be started 14 days post-PD catheter implantation (= D1) for a period of 4 weeks (D28) on top of optimized usual care for HF, while loop diuretic treatment is suspended.\n* Control Group (N = 10) Treatment: 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).\n\nAll subjects should then enter the 3 month safety follow-up period (D29-D120) until the end of study (D120).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged ≥18 years at screening\n* Weight at screening ≥50 kg (110 lbs)\n* Creatinine-based estimated glomerular filtration rate (eGFR) (CKD-EPI\\] 2021 formula) ≥30 mL/min/1.73m² at screening\n* 6-hour cumulative urine sodium excretion \\<100 mmol to 40 mg IV furosemide on diuretic challenge\n* 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\n* 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\n* Systolic blood pressure ≥90 mmHg and \\<180 mmHg\n* Receiving maximally tolerated stable doses of guideline-directed medical therapy (GDMT)\n* 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\n* 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\n\nExclusion Criteria:\n\n* Reversible cause of persistent decompensation or diuretic resistance\n* Contraindications for peritoneal dialysis (PD) or PD catheter placement\n* Known contraindication to icodextrin use\n* Known contraindication or intolerance or allergy to SGLT2 inhibitors\n* Current diagnosis of severe bladder dysfunction\n* Imminent need for hospitalization\n* Current or prior (past 6 months) use of renal replacement therapy\n* Anemia with hemoglobin \\<8 g/dL\n* Serum sodium \\<130 mEq/L\n* Severe albuminuria (urinary albumin/creatinine ratio \\>1 at screening)\n* Severe cardiac cachexia\n* Clinically significant cirrhosis or history of clinically significant ascites (i.e., prior large volume paracentesis) or large volume ascites on imaging or exam\n* Type 1 diabetes, uncontrolled Type 2 diabetes, "brittle" diabetes or frequent hypoglycemia or severe hyperglycemic episodes requiring emergent intervention in the last 6 months\n* Known or suspected low output HF\n* Prior or planned heart transplant or mechanical cardiac support implantation (LVAD)\n* History of severe hyperkalemia \\> 5.5 mEq/L (past 6 months) or screening plasma potassium \\>4.5 mEq/L\n* Significant non-cardiac disease or comorbidities expected to reduce life expectancy to \\<1 year or to interfere with safety or conduct of the study\n* Severe restrictive or obstructive HF or hemodynamically significant, severe uncorrected stenotic valvular disease\n* Receiving anticoagulation or antiplatelet treatment, which cannot be withheld (bridging therapy allowed)\n* 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)\n* Received treatment with other investigational products or devices within 30 days of screening or 5 halflives of the previous investigational product\n* Pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT05965934', 'acronym': 'MOJAVE', 'briefTitle': 'Management of Volume Overload HF Patients by Individual DSR Treatment adJustment-a clinicAl inVestigation of InfusatE2.0', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sequana Medical N.V.'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': '2022-CHF-012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Direct Sodium Removal (DSR) Infusate 2.0', 'description': '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).', 'interventionNames': ['Drug: Direct Sodium Removal Infusate 2.0']}, {'type': 'NO_INTERVENTION', 'label': 'Optimized Usual Care for HF', 'description': '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': [{'name': 'Direct Sodium Removal Infusate 2.0', 'type': 'DRUG', 'otherNames': ['SGLT-2 inhibitor (dapagliflozin)'], 'description': '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.', 'armGroupLabels': ['Direct Sodium Removal (DSR) Infusate 2.0']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jeffrey Turner, MD', 'role': 'CONTACT', 'email': 'jeffrey.turner@yale.edu', 'phone': '203-785-2020'}], 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'centralContacts': [{'name': 'Jeroen Capel', 'role': 'CONTACT', 'email': 'Jeroen.capel@sequanamedical.com', 'phone': '+41 444 03 55 12'}, {'name': 'Oliver Goedje', 'role': 'CONTACT', 'email': 'oliver.goedje@sequanamedical.com', 'phone': '+32 9 292 80 65'}], 'overallOfficials': [{'name': 'Jeffrey Turner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale Universtiry'}, {'name': 'Marath Fudim, MD MHS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sequana Medical N.V.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}