Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2025-12-25 @ 3:21 PM
Study NCT ID:
NCT06362668
Status:
COMPLETED
Last Update Posted:
2025-03-10
First Post:
2024-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EU Sites: Fluid Management of Acute Decompensated Heart Failure With Reprieve Decongestion Management System (FASTR-EU)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004232', 'term': 'Diuretics'}, {'id': 'D005665', 'term': 'Furosemide'}, {'id': 'D002034', 'term': 'Bumetanide'}, {'id': 'D000077786', 'term': 'Torsemide'}, {'id': 'D006852', 'term': 'Hydrochlorothiazide'}, {'id': 'D000086', 'term': 'Acetazolamide'}], 'ancestors': [{'id': 'D045283', 'term': 'Natriuretic Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D013424', 'term': 'Sulfanilamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D062368', 'term': 'meta-Aminobenzoates'}, {'id': 'D062365', 'term': 'Aminobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002740', 'term': 'Chlorothiazide'}, {'id': 'D001581', 'term': 'Benzothiadiazines'}, {'id': 'D049971', 'term': 'Thiazides'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D013830', 'term': 'Thiadiazoles'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D001393', 'term': 'Azoles'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-04-11', 'size': 572358, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-04-11T13:32', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-07', 'studyFirstSubmitDate': '2024-02-21', 'studyFirstSubmitQcDate': '2024-04-08', 'lastUpdatePostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total sodium loss (in mmol of sodium) per 24 hours', 'timeFrame': 'End of treatment, an average of 72 hours', 'description': 'Primary efficacy endpoint is total sodium loss in mmol of sodium at end of randomized therapy normalized to 24 hours (up to a maximum of 72 hours).'}, {'measure': 'Comparison of occurrence of composite endpoint comprised of clinically significant acute kidney injury, severe electrolyte abnormality, or symptomatic hypotension or hypertensive emergency.', 'timeFrame': 'Through study completion, an average of 90 days', 'description': 'Primary safety endpoint is positive if any of the following occurs in an individual participant:\n\n1. Clinically significant acute kidney injury defined as Kidney Disease-Improving Global Outcomes (KDIGO) stage 2 or greater Acute Kidney Injury (AKI) \\[≥ doubling of baseline serum creatinine or use of renal replacement therapy (RRT)\\]\n2. Severe electrolyte abnormality defined as serum potassium \\<3.0 milliequivalent/liter (mEq/L), magnesium \\<1.3 mEq/L, or sodium \\<135 mEq\n3. Symptomatic hypotension (systolic pressure \\<80mmHg) or hypertensive (systolic pressure \\>200 mmHg and/or diastolic pressure \\>120 mmHg) emergency.'}], 'secondaryOutcomes': [{'measure': 'Total net fluid volume loss (difference between urine output volume and fluid input volume) per 24 hours', 'timeFrame': 'End of treatment, an average of 72 hours', 'description': 'Difference between volume of urine output and fluid input during primary treatment normalized to 24 hours.'}, {'measure': 'Weight loss per 24 hours at end of randomized therapy', 'timeFrame': 'End of treatment, an average of 72 hours', 'description': 'Total time on loop diuretics during primary treatment'}, {'measure': 'Time on IV loop diuretic', 'timeFrame': 'End of treatment, an average of 72 hours', 'description': 'Total time on loop diuretics from initiation of randomized therapy to last dose of IV loop diuretic administered for ADHF'}, {'measure': 'Number of participants with ≥ 0.3 mg/dL increase in serum creatinine', 'timeFrame': 'End of treatment, an average of 72 hours', 'description': 'In hospital worsening renal function defined as ≥ 0.3 mg/dL increase in serum creatinine during randomized therapy.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Acute Decompensated Heart Failure']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to prospectively compare decongestive therapy administered by the Reprieve DMS system to Optimal Diuretic Therapy (ODT) in the treatment of patients diagnosed with acute decompensated heart failure (ADHF). The main objective is to determine if the Reprieve DMS is non-inferior to state-of-the-art urine sodium guided aggressive diuretic titration in two European HF centers of excellence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Hospitalized with a diagnosis of heart failure as defined by the presence of at least 1 symptom AND 1 sign.\n2. ≥10 pounds (4.5 kg) above dry weight either by historical weights or as estimated by health care provider.\n3. Prior use of loop diuretics within 30 says prior to admission.\n4. ≥ 18 years of age able to provide informed consent and comply with study procedures.\n\nExclusion Criteria:\n\n1. Inability to place Foley catheter or IV catheter.\n2. Hemodynamic instability.\n3. Dyspnea due primarily to non-cardiac causes.\n4. Acute infection with evidence of systemic involvement.\n5. Estimated glomerular filtration rate (eGFR) \\< 20 ml/min/1.73m2 calculated using the MDRD equation or current use of renal replacement therapy.\n6. Significant left ventricular outflow obstruction, uncorrected complex congenital heart disease, severe stenotic valvular disease, infiltrative or constrictive cardiomyopathy, acute myocarditis, type 1 acute myocardial infarction requiring treatment, or any other pathology that, in the opinion of the investigator, would make aggressive diuresis poorly tolerated.\n7. Inability to follow instructions or comply with follow-up procedures.\n8. Other concomitant disease or condition that investigator deems unsuitable for the study, including drug or alcohol abuse or psychiatric, behavioral or cognitive disorders, sufficient to interfere with the patient's ability to understand and comply with the study instructions or follow-up procedures.\n9. Severe electrolyte abnormalities.\n10. Presence of active coronavirus disease 2019 (COVID-19) infection.\n11. Enrollment in another interventional trial during the index hospitalization.\n12. Inability to return for follow-up study visits.\n13. Life expectancy less than 3 months.\n14. Women who are pregnant or intend to become pregnant."}, 'identificationModule': {'nctId': 'NCT06362668', 'acronym': 'FASTR-EU', 'briefTitle': 'EU Sites: Fluid Management of Acute Decompensated Heart Failure With Reprieve Decongestion Management System (FASTR-EU)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Reprieve Cardiovascular, Inc'}, 'officialTitle': 'EU Sites: Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve Decongestion Management System (DMS) (FASTR-EU)', 'orgStudyIdInfo': {'id': 'RCV-0006-EU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Reprieve Decongestion Management System', 'description': 'Subjects randomized to Reprieve System will receive personalized and optimized diuretic and saline infusion using the study device during the course of the treatment.', 'interventionNames': ['Device: Reprieve Decongestion Management System']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Optimal Diuretic Therapy', 'description': 'Sites will consider best practices of optimal diuretic dosing such as those demonstrated in recent randomized trials \\[Diuretic Strategies in Patients with Acute Heart Failure Trail (DOSE), Acetazolamide in Decompensated Heart Failure with Volume Overload Trial (ADVOR), and Safety and Efficacy of the Combination of Loop with Thiazide-type Diuretics in Patients with Decompensated Heart Failure Trial (CLOROTIC)\\] for patients randomized to control arm of the trial.', 'interventionNames': ['Drug: Diuretic (furosemide, bumetanide, torsemide, hydrochlorothiazide, and/or acetazolamide)']}], 'interventions': [{'name': 'Reprieve Decongestion Management System', 'type': 'DEVICE', 'description': "The Reprieve Decongestion Management System, or Reprieve DMS, is a hospital bedside fluid management console designed to provide personalized and automated infusion of the IV diuretic furosemide and physiological saline in response to the patient's real-time urine output to safely and rapidly decongest patients suffering from Acute Decompensated Heart Failure.", 'armGroupLabels': ['Reprieve Decongestion Management System']}, {'name': 'Diuretic (furosemide, bumetanide, torsemide, hydrochlorothiazide, and/or acetazolamide)', 'type': 'DRUG', 'description': 'Best practices of optimal diuretic dosing such as those demonstrated in recent randomized trials (DOSE, ADVOR, CLOROTIC).', 'armGroupLabels': ['Optimal Diuretic Therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Groningen', 'country': 'Netherlands', 'facility': 'University Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Wroclaw Medical University', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Reprieve Cardiovascular, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}