Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2026-01-04 @ 2:37 AM
Study NCT ID:
NCT02355769
Status:
COMPLETED
Last Update Posted:
2018-11-14
First Post:
2015-01-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Complex Pathophysiological Background of Heart Failure Deterioration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}, 'targetDuration': '24 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-10', 'studyFirstSubmitDate': '2015-01-22', 'studyFirstSubmitQcDate': '2015-01-30', 'lastUpdatePostDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'significant electrolyte disturbances (K <3,0mmol/l; Na < 120mmol/l and or change in Na 10 mmol/l)', 'timeFrame': '8 days', 'description': 'time frame - assumed mean time of hospitalization'}, {'measure': 'symptomatic hypotension (SBP <90 mmHg or change in40 mmHg)', 'timeFrame': '8 days', 'description': 'time frame - assumed mean time of hospitalization'}, {'measure': 'hospitalization time (days)', 'timeFrame': '8 days', 'description': 'time frame - assumed mean time of hospitalization'}, {'measure': 'change in NYHA class', 'timeFrame': '8 days', 'description': 'time frame - assumed mean time of hospitalization'}, {'measure': '"diuretic effectiveness ratio" - change in body mass change [%]/diuretics use [mg]', 'timeFrame': '8 days', 'description': 'time frame - assumed mean time of hospitalization'}, {'measure': 'change in HR', 'timeFrame': '8 days', 'description': 'time frame - assumed mean time of hospitalization'}, {'measure': 'change in SBP', 'timeFrame': '8 days', 'description': 'time frame - assumed mean time of hospitalization'}, {'measure': 'change in DBP', 'timeFrame': '8 days', 'description': 'time frame - assumed mean time of hospitalization'}, {'measure': 'change in SI', 'timeFrame': '8 days', 'description': 'time frame - assumed mean time of hospitalization'}, {'measure': 'change in CI', 'timeFrame': '8 days', 'description': 'time frame - assumed mean time of hospitalization'}, {'measure': 'change in TFC', 'timeFrame': '8 days', 'description': 'time frame - assumed mean time of hospitalization'}, {'measure': 'change in SVRI', 'timeFrame': '8 days', 'description': 'time frame - assumed mean time of hospitalization'}, {'measure': 'change in body mass', 'timeFrame': '8 days', 'description': 'time frame - assumed mean time of hospitalization'}, {'measure': 'change in TBW', 'timeFrame': '8 days', 'description': 'time frame - assumed mean time of hospitalization'}, {'measure': 'change in ECW', 'timeFrame': '8 days', 'description': 'time frame - assumed mean time of hospitalization'}, {'measure': 'change in ICW', 'timeFrame': '8 days', 'description': 'time frame - assumed mean time of hospitalization'}, {'measure': 'change in bilirubin', 'timeFrame': '8 days', 'description': 'time frame - assumed mean time of hospitalization'}, {'measure': 'change in eGFR', 'timeFrame': '8 days', 'description': 'time frame - assumed mean time of hospitalization'}, {'measure': 'change in urea', 'timeFrame': '8 days', 'description': 'time frame - assumed mean time of hospitalization'}, {'measure': 'change in hemoglobin', 'timeFrame': '8 days', 'description': 'time frame - assumed mean time of hospitalization'}, {'measure': 'change in hematocrit', 'timeFrame': '8 days', 'description': 'time frame - assumed mean time of hospitalization'}, {'measure': 'change in NTproBNP', 'timeFrame': '8 days', 'description': 'time frame - assumed mean time of hospitalization'}, {'measure': 'change in pH', 'timeFrame': '8 days', 'description': 'time frame - assumed mean time of hospitalization'}, {'measure': 'change in lactates', 'timeFrame': '8 days', 'description': 'time frame - assumed mean time of hospitalization'}], 'primaryOutcomes': [{'measure': 'in-hospital death', 'timeFrame': '8 days', 'description': 'time frame - assumed mean time of hospitalization'}, {'measure': 'combined primary endpoint (in-hospital death and/or myocardial infract and/or stroke and/or serious arrhythmia and/or worsening renal function)', 'timeFrame': '8 days', 'description': 'time frame - assumed mean time of hospitalization'}], 'secondaryOutcomes': [{'measure': 'myocardial infract', 'timeFrame': '8 days', 'description': 'time frame - assumed mean time of hospitalization'}, {'measure': 'stroke (clinical symptoms and confirmed in CT)', 'timeFrame': '8 days', 'description': 'time frame - assumed mean time of hospitalization'}, {'measure': 'serious arrhythmia (new onset sustained ventricular tachycardia/fibrillation, supraventricular tachycardia, atrial fibrillation/flutter, sustained bradycardia <40/min)', 'timeFrame': '8 days', 'description': 'time frame - assumed mean time of hospitalization'}, {'measure': 'worsening renal function (increase in creatinine 0,3mg/dl according to the definition of AKDI)', 'timeFrame': '8 days', 'description': 'time frame - assumed mean time of hospitalization'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['heart failure', 'renal failure', 'prognosis', 'impedance cardiography'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'Preventing heart failure (HF) deterioration is a great challenge for contemporary medicine. The progress course of HF is with increasing frequency of subsequent hospitalizations (approximately 30% of hospitalizations are the repeated ones). It is estimated that the costs of hospital stays constitute nearly 2/3 of healthcare costs provided for HF patients. The difficulty in treatment of patients with HF deterioration is associated with numerous comorbidities and coexisting complications (i.e. aggravation of ischaemic heart disease, lung diseases, infections, electrolyte disturbances, anaemia, renal failure as well as operations, in particular emergency ones). Our study is aimed to evaluation the complex pathophysiological background related to heart failure deterioration with respect to the effect of applied in-hospital treatment.', 'detailedDescription': 'PURPOSE:\n\nTreatment of patients with heart failure (HF) is a great challenge for contemporary medicine. HF frequency in European population is assessed for 0.4 - 2%. This disease is characterized by high morbidity and mortality rate, poor quality of life and the necessity of frequent hospitalizations. Along with the medicine progress, in particular in the scope of acute coronary syndromes treatment, the number of HF patients is constantly growing. The essential problem connected with HF is its progress course and an increasing frequency of subsequent hospitalizations (approximately 30% of hospitalizations are the repeated ones). It is estimated that the costs of hospital stays constitute nearly 2/3 of healthcare costs provided for HF patients. In the United States approximately 50% of HF patients have been rehospitalized within 6 months from discharge and 70% of these hospitalizations were caused by HF deterioration.The prognosis in HF is closely connected with the progression of the disease defined in accordance with the NYHA (New York Heart Association) functional classification. The yearly mortality rate among each NYHA class is: class 1 - up to 10%, class 2 - 10-20%, class 3 - 20-40%, class 4 - mortality 40-60%. Over half of the patients with symptomatic HF die within 4 years of observation The high in-hospital mortality has been a great problem and results not only from the natural history of HF progression, but also from a number of coexisting complications (i.e. aggravation of ischaemic heart disease, lung diseases, infections, electrolyte disturbances, anaemia, renal failure as well as operations, in particular emergency ones). The optimal schemes of identifying the individual risk are of fundamental importance to guide the safe therapy. Undoubtedly hemodynamic status and its change during hospitalization is one of the main predictive factors of treatment response and occurrences of adverse effects of therapy, i.e. renal function worsening. However, there are no clear guidelines on how to perform safe and effective non-invasive hemodynamic monitoring.\n\nAIMS:\n\nThe evaluation of complex pathophysiological features related to heart failure deterioration, including the parameters characterizing i.e. cardiovascular hemodynamics, hydration status, renal failure, iron metabolism and gas exchange, with respect to the effect of applied in-hospital treatment The evaluation of clinical value of the parameters characterizing i.e. cardiovascular hemodynamics, hydration status, renal failure, iron metabolism and gas exchange in prognosis of patients with heart failure deterioration\n\nMETHODS:\n\nAll the recruited patients will undergo the following assessment:\n\nClinical examination Laboratory tests, ncluding i.e. white blood cells count, red blood cells count, hemoglobin, hematocrit, mean cell volume (MCV), red cell distribution width (RDW); sodium, potassium, creatinine, estimated glomerular filtration rat (eGFR), urea, cystatin C; fasting glucose; bilirubin; total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), triglycerides, N-terminal of the prohormone brain natriuretic peptide (NT-proBNP); hs-TnT (high sensitive troponin T), iron; ferritin; unsaturated iron binding capacity (UIBC), total iron binding capacity (TIBC), transferrin saturation, soluble transferrin receptor; pH, carbon dioxide partial pressure (pCO2), oxygen partial pressure (pO2), arterial oxygen saturation (SaO2), bicarbonate content (HCO3-), base excess (BE), lactates; thyroid-stimulating hormone (TSH), testosterone, dehydroepiandrosterone sulfate (DHEAS), estradiol Electrocardiogram Echocardiography Chest X-ray Holter-ekg monitoring ambulatory blood pressure monitoring impedance cardiography (including assessment of: resting heart rate (HR), systolic and diastolic blood pressure (SBP and DBP), thoracic fluid content (TFC), cardiac index (CI), stroke index (SI), systemic vascular resistance index (SVRI) bioimpedance (including assessment total body water (TBW), intracellular and extracellular water (ICW, ECW)) applanation tonometry (including assessment of augmentation index (AI) and central pulse pressure (CPP))'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with heart failure admitted to the Department of Internal Diseases and Cardiology urgently because of symptomatic heart failure deterioration', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* patients of either sex\n* urgent hospitalization caused by deterioration of HF.\n\nExclusion Criteria:\n\n* unstable coronary artery disease including myocardial infarct within the last 40 days prior to recruitment\n* stroke within 40 days prior to recruitment\n* cardiac surgery within 90 days prior to recruitment\n* pulmonary embolism\n* severe pulmonary diseases (chronic obstructive pulmonary diseases - stage C/D, uncontrolled asthma, pulmonary hypertension)\n* chronic kidney disease (stage 5 and requiring dialysis)\n* severe inflammatory disease\n* severe mental and physical disorders\n* patients' refusal to participate"}, 'identificationModule': {'nctId': 'NCT02355769', 'briefTitle': 'Complex Pathophysiological Background of Heart Failure Deterioration', 'organization': {'class': 'OTHER', 'fullName': 'Military Institute od Medicine National Research Institute'}, 'officialTitle': 'Multiparametric Assessment of Complex Pathophysiological Background of Heart Failure Deterioration - Relation to Treatment Effects and Prognosis', 'orgStudyIdInfo': {'id': 'WIM-0000000213'}}, 'contactsLocationsModule': {'locations': [{'zip': '04-141', 'city': 'Warsaw', 'state': 'Masovian Voivodeship', 'country': 'Poland', 'facility': 'Military Institute of Medicine', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'overallOfficials': [{'name': 'Pawel Krzesinski, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Military Institute of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Military Institute od Medicine National Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Scientific Assistant', 'investigatorFullName': 'Paweł Krzesiński', 'investigatorAffiliation': 'Military Institute od Medicine National Research Institute'}}}}