Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2026-01-01 @ 10:27 PM
Study NCT ID:
NCT06418932
Status:
RECRUITING
Last Update Posted:
2024-10-21
First Post:
2024-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Compression Therapy of the Lower Limbs in Patients With Decompensated Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Sham procedure. Blinded to treatment allocation. The investigator and the patients will be blinded to treatment assignments. For this purpose, a restraint system will be used which will be applied to the lower limbs and will mask the assignment.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be assigned to standard treatment (parenteral administration of furosemide) versus parenteral administration of furosemide plus lower limb compression therapy for a maximum of 72 hours. The dose of furosemide in all participants will be based on the clinical judgment of the responsible health professional.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 106}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-18', 'studyFirstSubmitDate': '2024-05-13', 'studyFirstSubmitQcDate': '2024-05-16', 'lastUpdatePostDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Tolerance', 'timeFrame': '72 hours', 'description': 'Percentage of patients in whom tolerance of the compressive bandage is achieved at 24 and 72 hours'}, {'measure': 'eGFR', 'timeFrame': '72 hours', 'description': 'Estimated glomerular filtration rate (eGFR) at 72 hours'}, {'measure': 'Electrolyte disturbances', 'timeFrame': '72 hours', 'description': 'Electrolyte disturbances at 72 hours (hyponatremia: \\<135 mmo/l, hypernatremia\\>150 mmo/l, hypokalemia\\<3.5 mmo/l and hyperkalemia\\>5 mmo/l)'}, {'measure': 'Clinical adverse events', 'timeFrame': '30 days', 'description': 'Clinical adverse events at 30 days total and cardiovascular, with special emphasis on cardiovascular death and HF decompensation'}], 'primaryOutcomes': [{'measure': 'Natriuresis', 'timeFrame': '24 hours', 'description': 'Changes in natriuresis at 24 hours after randomization.'}, {'measure': 'Weight', 'timeFrame': '24 hours', 'description': 'Changes in weight at 24 hours after randomization'}], 'secondaryOutcomes': [{'measure': 'Diameter of the lower limbs', 'timeFrame': '72 hours', 'description': 'Changes in the diameter of the lower limbs (at 5 and 10 cm from the ankles) at 24 and 72 hours after randomization.'}, {'measure': 'Congestion score', 'timeFrame': '72 hours', 'description': 'Changes in clinical congestion score at 24 and 72 hours'}, {'measure': 'Inferior vena cava diameter', 'timeFrame': '72 hours', 'description': 'Changes in inferior vena cava diameter at 3, 24 and 72 hours'}, {'measure': 'NT-proBNP', 'timeFrame': '72 hours', 'description': 'Changes in circulating levels of the N-terminal portion of B-type natriuretic pro-peptide (NT-proBNP) at 72 hours.'}, {'measure': 'CA125', 'timeFrame': '15±3 days', 'description': 'Changes in circulating levels of carbohydrate antigen 125 (CA125) at 15±3 days'}, {'measure': 'Doses of furosemide', 'timeFrame': '72 hours', 'description': 'Doses of furosemide equivalents used in the first 72 hours after randomization'}, {'measure': 'Time to oral administration.', 'timeFrame': '72 hours', 'description': 'Time to switch from diuretics to oral administration'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'Randomized 1:1 multicenter double-blind clinical investigation evaluating the efficacy and safety of compression therapy of the lower limbs plus parenteral administration of diuretics vs. administration of parenteral diuretics alone (standard treatment) in patients with decompensated HF and predominantly systemic tissue congestion and absence of intravascular systemic congestion.\n\nPatients will be assigned to standard treatment (parenteral administration of furosemide) versus parenteral administration of furosemide plus lower limb compression therapy for up to 72 hours. The dose of furosemide in all participants will be based on the clinical judgment of the responsible healthcare professional.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 years or older.\n* Patient with clinical judgment of acute decompensated heart failure in the first 96 hours from the start of parenteral diuretic treatment.\n* Patient treated with furosemide at least 40 mg in the last 24 hours.\n* NT-proBNP levels\\>1000 pg/ml at least 1 time since the onset of decompensation.\n* Presence of tibio-malleolar edema at least grade II/IV at the time of inclusion.\n* Inferior vena cava (IVC) diameter on ultrasonography ≤21 mm at the time of the "screening" visit.\n\nExclusion Criteria:\n\n* Being admitted to the Intensive Care Unit.\n* Renal transplant, chronic renal failure stage 5 (eGFR \\<15 ml/min/1.73m2) or being included in dialysis program (peritoneal/hemodialysis) or in need of ultrafiltration.\n* Absence of peripheral pulses.\n* Ankle brachial index (ABI) \\<0.9.\n* History of severe peripheral artery disease.\n* Previous intolerance to compressive bandaging.\n* HF secondary to acute myocardial infarction.'}, 'identificationModule': {'nctId': 'NCT06418932', 'briefTitle': 'Compression Therapy of the Lower Limbs in Patients With Decompensated Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Fundación para la Investigación del Hospital Clínico de Valencia'}, 'officialTitle': 'Compression Therapy of the Lower Limbs in Patients With Decompensated Heart Failure and Predominant Systemic Tissue Congestion', 'orgStudyIdInfo': {'id': 'COMPRESSION-HF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Compressive', 'description': 'Compressive therapy of the lower limbs plus parenteral administration of diuretics', 'interventionNames': ['Device: UrgoK2 / UrgoK2 Lite']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Parenteral diuretics alone', 'interventionNames': ['Other: Controll']}], 'interventions': [{'name': 'UrgoK2 / UrgoK2 Lite', 'type': 'DEVICE', 'description': 'Multicomponent compressive bandage system consisting of an internal bandage of short traction and an external cohesive bandage of long traction, with pressure indicators on both bandages, which provides a sustained ankle pressure of \\~20/40mmHg.', 'armGroupLabels': ['Compressive']}, {'name': 'Controll', 'type': 'OTHER', 'description': 'Administration of parenteral diuretics only', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03700', 'city': 'Denia', 'state': 'Alicante', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Sergio Luengo Pérez', 'role': 'CONTACT', 'email': 'sergioluepe@gmail.com', 'phone': '651593649'}], 'facility': 'Hospital de Denia', 'geoPoint': {'lat': 38.84078, 'lon': 0.10574}}, {'zip': '03186', 'city': 'Torrevieja', 'state': 'Alicante', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'María Montesinos Aldeguer', 'role': 'CONTACT', 'email': 'marieta336@hotmail.com', 'phone': '670257680'}], 'facility': 'Hospital Universitario de Torrevieja', 'geoPoint': {'lat': 37.97872, 'lon': -0.68222}}, {'zip': '08025', 'city': 'Barcelona', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Clara Simón Ramón', 'role': 'CONTACT', 'email': 'simonramonc@gmail.com', 'phone': '678220578'}], 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28034', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Pau Llàcer Iborra', 'role': 'CONTACT', 'email': 'paullacer@hotmail.com', 'phone': '639202963'}], 'facility': 'Hospital Universitario Ramón y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28222', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Juan Carlos López-Azor', 'role': 'CONTACT', 'email': 'lopez.gcia.juan.carlos@gmail.com', 'phone': '628026462'}], 'facility': 'Hospital Puerta de Hierro', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '30120', 'city': 'Murcia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Francisco José Pastor Pérez', 'role': 'CONTACT', 'email': 'franpastor79@hotmail.com', 'phone': '932 91 90 00'}], 'facility': 'Hospital Clínico Universitario Virgen de la Arrixaca', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}, {'zip': '46014', 'city': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'José Pérez Silvestre', 'role': 'CONTACT', 'email': 'jopesilver@hotmail.com', 'phone': '630786752'}], 'facility': 'Hospital General de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Julio JN Nuñez', 'role': 'CONTACT', 'email': 'yulnunez@gmail.com', 'phone': '652856689', 'phoneExt': '+34'}], 'facility': 'Hospital Clínico Universitario de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación para la Investigación del Hospital Clínico de Valencia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}