Clinical trial NCT06959927: Risk Factors and Application of Risk Management Strategies in Hemodialysis Patients Complicated With Heart Failure
Official title: Risk Factors and Application of Risk Management Strategies in Hemodialysis Patients Complicated With Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis
Heart Failure
Lead sponsor: Changsha Fourth Hospital
Sponsor class: OTHER_GOV
First posted: 2025-05-07
Enrollment: 170
Sex: ALL
Minimum age (years): 38
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients were aged 18 years or older who had been undergoing regular hemodialysis treatment for more than three months.

  * Patients were in good cardiopulmonary health without severe acute or chronic diseases, and were capable of undergoing the study-related examinations and treatments.

    * Patients had not undergone major surgeries or experienced acute complications within the three months prior to enrollment, and their conditions were stable.

      * Patients demonstrated high compliance by following medical advice and regularly attending dialysis sessions and related examinations.

        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.

Exclusion Criteria:

* 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.

  * Patients with congenital kidney diseases, congenital heart defects, or other severe congenital structural abnormalities were excluded.

    * 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.

      * Patients were excluded if they had severe mental disorders or cognitive impairments that prevented their cooperation with study assessments or treatments.

        ⑤Patients whose clinical records or examination data were incomplete, thereby precluding effective analysis, were excluded.

Primary outcomes:
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.
Secondary outcomes:
measure: Change in Inflammatory Biomarkers
timeFrame: Baseline, 3 months, and 6 months.
measure: Glycemic Control Improvement
timeFrame: Baseline and 6 months.
measure: Change in Psychological Distress (SAS/SDS Scores)
timeFrame: Baseline, 6, 12, and 24 months
measure: Complication Rates
timeFrame: Over 12 months.
measure: Nursing Satisfaction Score
timeFrame: 24 months
Other outcomes:
measure: Biomarker Correlates (HbA1c, CRP)
timeFrame: Baseline, 12, and 24 months
measure: Hospitalization Frequency
timeFrame: 24 months
Locations:
city: Changsha
country: China
facility: Changsha Fourth Hospital
Study officials:
affiliation: Changsha Fourth Hospital
name: Guiren Hou, MB
role: PRINCIPAL_INVESTIGATOR
References: