Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2026-03-07 @ 2:04 PM
Study NCT ID:
NCT05318105
Status:
RECRUITING
Last Update Posted:
2025-05-15
First Post:
2022-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrafiltration Versus IV Diuretics in Worsening Heart Failure
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': 'D049994', 'term': 'Sodium Potassium Chloride Symporter Inhibitors'}], 'ancestors': [{'id': 'D049990', 'term': 'Membrane Transport Modulators'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D004232', 'term': 'Diuretics'}, {'id': 'D045283', 'term': 'Natriuretic Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 372}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-12', 'studyFirstSubmitDate': '2022-03-10', 'studyFirstSubmitQcDate': '2022-03-31', 'lastUpdatePostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to first heart failure (HF) event', 'timeFrame': 'within 30 days', 'description': 'Heart Failure (HF) event defined as any HF rehospitalization or unplanned use of IV loop diuretics, vasoactive medications or Aquadex therapy in any outpatient setting.'}], 'secondaryOutcomes': [{'measure': 'Win ratio analysis', 'timeFrame': 'within 30 days', 'description': 'Win ratio analysis of cardiovascular (CV) mortality, HF events and quality of life'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Heart failure', 'Fluid overload'], 'conditions': ['Heart Failure (for Example, Fluid Overload)', 'Heart Failure', 'Fluid Overload']}, 'referencesModule': {'references': [{'pmid': '36787124', 'type': 'DERIVED', 'citation': 'McCallum W, Sarnak MJ. Cardiorenal Syndrome in the Hospital. Clin J Am Soc Nephrol. 2023 Jul 1;18(7):933-945. doi: 10.2215/CJN.0000000000000064. Epub 2023 Jan 13.'}]}, 'descriptionModule': {'briefSummary': 'The REVERSE-HF study is a randomized controlled trial to evaluate clinical outcomes of adjustable ultrafiltration with the Aquadex System as compared to adjustable IV loop diuretics in patients with worsening heart failure (HF) and fluid overload.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* Man, or non-pregnant woman\n* Admitted to the hospital with a diagnosis of acute decompensated heart failure\n* On regularly prescribed oral loop diuretics, Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors or a Mineralcorticoid Receptor Antagonists (MRA) prior to admission\n* Fluid overload manifested by at least three clinical indications (e.g., edema, an excess of at least 10 pounds of fluid, etc.)\n* Provide written informed consent\n\nExclusion Criteria:\n\n* New diagnosis of heart failure\n* Acute coronary syndromes\n* Creatinine ≥ 3.0 mg/dl or planned renal replacement therapies at the time of enrollment\n* Contraindications to systemic anticoagulation\n* Severe concomitant disease expected to prolong hospitalization or cause death in less than 90 days\n* Sepsis or ongoing systemic infection\n* Active myocarditis\n* Constrictive pericarditis or restrictive cardiomyopathy\n* Severe aortic stenosis\n* Any condition in the opinion of the investigator that would prevent the patient from follow-up/survival'}, 'identificationModule': {'nctId': 'NCT05318105', 'acronym': 'REVERSE-HF', 'briefTitle': 'Ultrafiltration Versus IV Diuretics in Worsening Heart Failure', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nuwellis, Inc.'}, 'officialTitle': 'A Randomized Controlled Study to Evaluate the Safety and Effectiveness of the Aquadex System in Patients With Heart Failure and Fluid Overload', 'orgStudyIdInfo': {'id': 'CLIN07687'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aquadex ultrafiltration therapy', 'interventionNames': ['Device: Aquadex Smartflow® System']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IV loop diuretics', 'interventionNames': ['Drug: IV Loop Diuretics']}], 'interventions': [{'name': 'Aquadex Smartflow® System', 'type': 'DEVICE', 'description': 'ultrafiltration', 'armGroupLabels': ['Aquadex ultrafiltration therapy']}, {'name': 'IV Loop Diuretics', 'type': 'DRUG', 'description': 'diuretics', 'armGroupLabels': ['IV loop diuretics']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85721', 'city': 'Tucson', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dalise Dai', 'role': 'CONTACT', 'email': 'daliseshatz@arizona.edu', 'phone': '312-237-5891'}, {'name': 'Radha Gopalan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Banner Health', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Morgan Ebbert', 'role': 'CONTACT', 'email': 'MEbbert@memorialcare.org'}, {'name': 'Andrew Yoon, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'MemorialCare, Long Beach Medical Center', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Emma Burkhalter, RN, MSN', 'role': 'CONTACT', 'email': 'eburkhalter@sdcardiac.com', 'phone': '858-244-6889'}, {'name': 'Diana Nguyen', 'role': 'CONTACT', 'email': 'dnguyen@sdcardiac.com'}, {'name': 'Brian Jaski, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sharp Memorial Hospital, San Diego Cardiac Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'University of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '33756', 'city': 'Clearwater', 'state': 'Florida', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'BayCare Medical Group, Morton Plant', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33614', 'city': 'Tampa', 'state': 'Florida', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': "St. Joseph's Hospital", 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jennifer Isaacs', 'role': 'CONTACT', 'email': 'jennifer.isaacs@uky.edu', 'phone': '859-323-4738'}, {'name': 'Andrew Kolodziej, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kelsey Neaton', 'role': 'CONTACT', 'email': 'kneaton1@hfhs.org'}, {'name': 'Jennifer Cowger, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Henry Ford Health', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '10025', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Katharine Idrissi', 'role': 'CONTACT', 'email': 'katharine.idrissi2@mountsinai.org'}, {'name': 'Ashish Correa, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mount Sinai Morningside', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kathryn Bass', 'role': 'CONTACT', 'email': 'Kathryn.Bass@mountsinai.org', 'phone': '212-241-3149'}, {'name': 'Umesh Gidwani, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Mount Sinai Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10075', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alana Gulliver', 'role': 'CONTACT', 'email': 'agulliver@northwell.edu', 'phone': '212-434-3802'}, {'name': 'Sirish Vullaganti, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Northwell Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Karen Federle', 'role': 'CONTACT', 'email': 'karen.federle@thechristhospital.com'}, {'name': 'Sitaramesh Emani, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Christ Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43215', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'maeve McLoughlin, MPH', 'role': 'CONTACT', 'email': 'Maeve.McLoughlin@osumc.edu', 'phone': '614-292-4084'}, {'name': 'Sitaramesh Emani, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19001', 'city': 'Abington', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Colleen Marchand, RN', 'role': 'CONTACT', 'email': 'colleen.marchand@jefferson.edu', 'phone': '215-481-4661'}, {'name': 'Donald Haas, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Abington Jefferson Health', 'geoPoint': {'lat': 40.12067, 'lon': -75.11795}}, {'zip': '38301', 'city': 'Jackson', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mary Harris, RN', 'role': 'CONTACT', 'email': 'mary.harris@wth.org', 'phone': '731-541-6910'}, {'name': 'Shree Mulay, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Jackson Madison County General Hospital', 'geoPoint': {'lat': 35.61452, 'lon': -88.81395}}, {'zip': '75207', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amy Watts', 'role': 'CONTACT', 'email': 'Amy.Watts@BSWHealth.org', 'phone': '254-724-1392'}, {'name': 'Jamie Hernandez Montfort, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Baylor Scott & White Research Institute', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kelly Jordan', 'role': 'CONTACT', 'email': 'knjorda1@sentara.com'}, {'name': 'Ashley Williams', 'role': 'CONTACT', 'email': 'anwill10@sentara.com'}, {'name': 'Amin Yehya, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sentara Norfolk General Heart Hospital', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}], 'centralContacts': [{'name': 'Megan Cotts', 'role': 'CONTACT', 'email': 'megan.cotts@nuwellis.com', 'phone': '952-345-4217'}], 'overallOfficials': [{'name': 'Sean Pinney, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mount Sinai Morningside'}, {'name': 'Maria DeVita, MD, FASN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lenox Hill Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nuwellis, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}