Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2025-12-26 @ 4:11 AM
Study NCT ID:
NCT06959927
Status:
COMPLETED
Last Update Posted:
2025-05-07
First Post:
2025-03-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Risk Factors and Application of Risk Management Strategies in Hemodialysis Patients Complicated With 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': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 170}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-28', 'studyFirstSubmitDate': '2025-03-27', 'studyFirstSubmitQcDate': '2025-04-28', 'lastUpdatePostDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Biomarker Correlates (HbA1c, CRP)', 'timeFrame': 'Baseline, 12, and 24 months', 'description': 'Association between baseline HbA1c (\\>5.7%)/CRP (\\>3 mg/L) and HF incidence.'}, {'measure': 'Hospitalization Frequency', 'timeFrame': '24 months', 'description': 'All-cause and HF-related hospital admissions.'}], 'primaryOutcomes': [{'measure': 'Incidence of Major Adverse Cardiac Events (MACE) in Hemodialysis Patients with Heart Failure', 'timeFrame': 'From enrollment until first occurrence of any MACE component, assessed over 12 months.', 'description': 'Composite endpoint including:\n\nCardiovascular mortality (death due to heart failure, myocardial infarction, or arrhythmia).\n\nHospitalization for worsening heart failure (requiring IV diuretics, vasodilators, or mechanical support).\n\nDialysis-related cardiovascular complications (e.g., intradialytic hypotension, arrhythmias).'}], 'secondaryOutcomes': [{'measure': 'Change in Inflammatory Biomarkers', 'timeFrame': 'Baseline, 3 months, and 6 months.', 'description': 'Reduction in serum C-reactive protein (CRP) and interleukin-6 (IL-6) levels from baseline to 6 months.'}, {'measure': 'Glycemic Control Improvement', 'timeFrame': 'Baseline and 6 months.', 'description': 'Absolute change in glycated hemoglobin (HbA1c) levels in diabetic patients.'}, {'measure': 'Change in Psychological Distress (SAS/SDS Scores)', 'timeFrame': 'Baseline, 6, 12, and 24 months', 'description': 'Reduction in anxiety/depression scores post-intervention:\n\nSelf-rating Anxiety Scale (SAS; range 0-100, higher = worse)\n\nSelf-rating Depression Scale (SDS; range 0-100, higher = worse)'}, {'measure': 'Complication Rates', 'timeFrame': 'Over 12 months.', 'description': 'Incidence of dialysis-related complications (hypotension, pulmonary edema, infections).'}, {'measure': 'Nursing Satisfaction Score', 'timeFrame': '24 months', 'description': 'Patient-reported satisfaction (25-item Likert scale; 1-4 per item, total 25-100; higher = better), categorized as:\n\nVery satisfied (\\>90)\n\nSatisfied (70-90)\n\nDissatisfied (\\<70)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hemodialysis', 'Heart Failure']}, 'descriptionModule': {'briefSummary': 'Age, hyperglycemia, inflammation, and comorbidities (hypertension, diabetes, coronary disease) independently increase HF risk in hemodialysis patients. Targeted risk management reduces psychological distress, complications, and enhances care outcomes.', 'detailedDescription': 'To identify risk factors for heart failure (HF) in hemodialysis patients and assess the efficacy of targeted risk management strategies in improving prognosis and care quality. A total of 170 hospitalized dialysis patients from January 2022 to January 2024 were enrolled. They were divided into two groups based on the presence or absence of heart failure: the heart failure group (n=80) and the non-heart failure group (n=90). The inducing factors were analyzed, and targeted risk management strategies were implemented, with the participants further divided into a conventional group (n=40) and a study group (n=40) to explore the effect of these strategies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '68 Years', 'minimumAge': '38 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients were aged 18 years or older who had been undergoing regular hemodialysis treatment for more than three months.\n\n * Patients were in good cardiopulmonary health without severe acute or chronic diseases, and were capable of undergoing the study-related examinations and treatments.\n\n * Patients had not undergone major surgeries or experienced acute complications within the three months prior to enrollment, and their conditions were stable.\n\n * Patients demonstrated high compliance by following medical advice and regularly attending dialysis sessions and related examinations.\n\n ⑤Patients were able to understand the study objectives, had signed the informed consent form, and were willing to cooperate with follow-up visits and long-term observation.\n\nExclusion Criteria:\n\n* Patients were excluded if they had severe liver diseases (e.g., cirrhosis or liver failure), significant systemic infections, active tuberculosis, malignant tumors, connective tissue diseases, or other major illnesses.\n\n * Patients with congenital kidney diseases, congenital heart defects, or other severe congenital structural abnormalities were excluded.\n\n * Patients who had a documented history of severe cardiac diseases were excluded, including those with primary/secondary cardiomyopathy, valvular heart disease, myocarditis, or pericardial diseases.\n\n * Patients were excluded if they had severe mental disorders or cognitive impairments that prevented their cooperation with study assessments or treatments.\n\n ⑤Patients whose clinical records or examination data were incomplete, thereby precluding effective analysis, were excluded.'}, 'identificationModule': {'nctId': 'NCT06959927', 'briefTitle': 'Risk Factors and Application of Risk Management Strategies in Hemodialysis Patients Complicated With Heart Failure', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Changsha Fourth Hospital'}, 'officialTitle': 'Risk Factors and Application of Risk Management Strategies in Hemodialysis Patients Complicated With Heart Failure', 'orgStudyIdInfo': {'id': 'No. DSYY-2024-26'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Standard Care Group', 'description': 'Patients in this group received conventional hemodialysis care, including:\n\nContinuous monitoring of vital signs (blood pressure, respiratory rate, pulse, heart rhythm); Supplemental oxygen therapy as needed; Instruction on effective coughing techniques; Strict fluid and electrolyte management; Metabolic support therapies; Positional adjustments (upright posture with lower limb dependency); Environmental regulation (temperature: 22-24°C; humidity: 50-60%); Individualized dietary counseling.', 'interventionNames': ['Other: Standard Care Group']}, {'type': 'OTHER', 'label': 'Risk-Stratified Management Group', 'description': 'Patients in this group received standard care plus targeted risk management interventions:\n\nSystem Enhancement:\n\nStandardized nursing protocols and accountability frameworks Competency-based staff training (emergency response, fluid management) Individualized care plans (e.g., intensified glycemic control for diabetics, optimized BP monitoring for hypertensives)\n\nRisk Stratification:\n\nAdmission assessments and follow-up evaluations to identify high-risk patients Hemodynamic monitoring with alert thresholds for early deterioration detection Strict pharmacological supervision and fluid balance protocols\n\nEnvironmental Modification:\n\nOptimized dialysis unit conditions (temperature: 22-24°C; humidity: 50-60%) Dedicated cardiac care zones for HF patients\n\nQuality Control:\n\nQuarterly audits of critical care domains (patient education, vital signs documentation, protocol compliance, satisfaction metrics) Corrective actions for identified deficiencies', 'interventionNames': ['Other: Risk-Stratified Management Group']}], 'interventions': [{'name': 'Standard Care Group', 'type': 'OTHER', 'description': 'Patients in this group received conventional hemodialysis care, including:\n\nContinuous monitoring of vital signs (blood pressure, respiratory rate, pulse, heart rhythm); Supplemental oxygen therapy as needed; Instruction on effective coughing techniques; Strict fluid and electrolyte management; Metabolic support therapies; Positional adjustments (upright posture with lower limb dependency); Environmental regulation (temperature: 22-24°C; humidity: 50-60%); Individualized dietary counseling.', 'armGroupLabels': ['Standard Care Group']}, {'name': 'Risk-Stratified Management Group', 'type': 'OTHER', 'description': 'Patients in this group received standard care plus targeted risk management interventions:\n\nSystem Enhancement:\n\nStandardized nursing protocols and accountability frameworks Competency-based staff training (emergency response, fluid management) Individualized care plans (e.g., intensified glycemic control for diabetics, optimized BP monitoring for hypertensives)\n\nRisk Stratification:\n\nAdmission assessments and follow-up evaluations to identify high-risk patients Hemodynamic monitoring with alert thresholds for early deterioration detection Strict pharmacological supervision and fluid balance protocols\n\nEnvironmental Modification:\n\nOptimized dialysis unit conditions (temperature: 22-24°C; humidity: 50-60%) Dedicated cardiac care zones for HF patients\n\nQuality Control:\n\nQuarterly audits of critical care domains (patient education, vital signs documentation, protocol compliance, satisfaction metrics) Corrective actions for identified deficiencies', 'armGroupLabels': ['Risk-Stratified Management Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Changsha', 'country': 'China', 'facility': 'Changsha Fourth Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'overallOfficials': [{'name': 'Guiren Hou, MB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Changsha Fourth Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guiren Hou', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Guiren Hou', 'investigatorAffiliation': 'Changsha Fourth Hospital'}}}}