HemodialysisNCT06959927
Risk Factors and Application of Risk Management Strategies in Hemodialysis Patients Complicated With Heart Failure
A study testing Risk-Stratified Management Group in people with Hemodialysis and Heart Failure, run by Guiren Hou at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 38 to 68 years
- Conditions the study is for
- Hemodialysis, Heart Failure
- What is being tested?
- Risk-Stratified Management Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 38 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hemodialysis, Heart Failure
- Being tested
- Standard Care Group, Risk-Stratified Management Group
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Care GroupOther
Patients in this group received conventional hemodialysis care, including:
Continuous 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.
Risk-Stratified Management GroupOther
Patients in this group received standard care plus targeted risk management interventions:
System Enhancement:
Standardized 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)
Risk Stratification:
Admission 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
Environmental Modification:
Optimized dialysis unit conditions (temperature: 22-24°C; humidity: 50-60%) Dedicated cardiac care zones for HF patients
Quality Control:
Quarterly audits of critical care domains (patient education, vital signs documentation, protocol compliance, satisfaction metrics) Corrective actions for identified deficiencies
| Study group | Role | What they receive |
|---|---|---|
| Standard Care Group | Other | Patients in this group received conventional hemodialysis care, including:
Continuous 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. Receives: Other: Standard Care Group |
| Risk-Stratified Management Group | Other | Patients in this group received standard care plus targeted risk management interventions:
System Enhancement:
Standardized 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)
Risk Stratification:
Admission 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
Environmental Modification:
Optimized dialysis unit conditions (temperature: 22-24°C; humidity: 50-60%) Dedicated cardiac care zones for HF patients
Quality Control:
Quarterly audits of critical care domains (patient education, vital signs documentation, protocol compliance, satisfaction metrics) Corrective actions for identified deficiencies Receives: Other: Risk-Stratified Management Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Major Adverse Cardiac Events (MACE) in Hemodialysis Patients with Heart Failure
Composite endpoint including:
Cardiovascular mortality (death due to heart failure, myocardial infarction, or arrhythmia).
Hospitalization for worsening heart failure (requiring IV diuretics, vasodilators, or mechanical support).
Dialysis-related cardiovascular complications (e.g., intradialytic hypotension, arrhythmias).
Measured: From enrollment until first occurrence of any MACE component, assessed over 12 months.
Secondary outcomes (5)
Change in Inflammatory Biomarkers
Reduction in serum C-reactive protein (CRP) and interleukin-6 (IL-6) levels from baseline to 6 months.
Measured: Baseline, 3 months, and 6 months.
Glycemic Control Improvement
Absolute change in glycated hemoglobin (HbA1c) levels in diabetic patients.
Measured: Baseline and 6 months.
Change in Psychological Distress (SAS/SDS Scores)
Reduction in anxiety/depression scores post-intervention:
Self-rating Anxiety Scale (SAS; range 0-100, higher = worse)
Self-rating Depression Scale (SDS; range 0-100, higher = worse)
Measured: Baseline, 6, 12, and 24 months
Complication Rates
Incidence of dialysis-related complications (hypotension, pulmonary edema, infections).
Measured: Over 12 months.
Nursing Satisfaction Score
Patient-reported satisfaction (25-item Likert scale; 1-4 per item, total 25-100; higher = better), categorized as:
Very satisfied (>90)
Satisfied (70-90)
Dissatisfied (<70)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start1 Jan 2022
- Primary completion1 Jan 2024
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guiren Hou
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Guiren Hou, Changsha Fourth Hospital
- Investigators
- Guiren Hou, MB, Principal investigator, Changsha Fourth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06959927
- Sponsor's protocol ID
- No. DSYY-2024-26
- Status last verified
- Apr 2025
- First submitted
- 27 Mar 2025
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors and Application of Risk Management Strategies in Hemodialysis Patients Complicated With Heart Failure
- ClinicalTrials.gov ID
- NCT06959927
- Acronym / sponsor ID
- No. DSYY-2024-26
- Conditions
- Hemodialysis, Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Guiren HouOther government
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 7 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care Group | Other | Other: Standard Care GroupPatients in this group received conventional hemodialysis care, including: Continuous 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. |
| Risk-Stratified Management Group | Other | Other: Risk-Stratified Management GroupPatients in this group received standard care plus targeted risk management interventions: System Enhancement: Standardized 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) Risk Stratification: Admission 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 Environmental Modification: Optimized dialysis unit conditions (temperature: 22-24°C; humidity: 50-60%) Dedicated cardiac care zones for HF patients Quality Control: Quarterly audits of critical care domains (patient education, vital signs documentation, protocol compliance, satisfaction metrics) Corrective actions for identified deficiencies |
Who may qualify
- Ages
- 38 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients were aged 18 years or older who had been undergoing regular hemodialysis treatment for more than three months.
- 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.
Key exclusion criteria (5 listed)
- 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.
- ⑤Patients whose clinical records or examination data were incomplete, thereby precluding effective analysis, were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Care GroupPatients in this group received conventional hemodialysis care, including: Continuous 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. | Other | Standard Care Group |
| Risk-Stratified Management GroupPatients in this group received standard care plus targeted risk management interventions: System Enhancement: Standardized 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) Risk Stratification: Admission 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 Environmental Modification: Optimized dialysis unit conditions (temperature: 22-24°C; humidity: 50-60%) Dedicated cardiac care zones for HF patients Quality Control: Quarterly audits of critical care domains (patient education, vital signs documentation, protocol compliance, satisfaction metrics) Corrective actions for identified deficiencies | Other | Risk-Stratified Management Group |
Primary outcome
Incidence of Major Adverse Cardiac Events (MACE) in Hemodialysis Patients with Heart Failure
Time frame: From enrollment until first occurrence of any MACE component, assessed over 12 months.
Composite endpoint including: Cardiovascular mortality (death due to heart failure, myocardial infarction, or arrhythmia). Hospitalization for worsening heart failure (requiring IV diuretics, vasodilators, or mechanical support). Dialysis-related cardiovascular complications (e.g., intradialytic hypotension, arrhythmias).
5 secondary outcomes
Change in Inflammatory Biomarkers
Time frame: Baseline, 3 months, and 6 months.
Glycemic Control Improvement
Time frame: Baseline and 6 months.
Change in Psychological Distress (SAS/SDS Scores)
Time frame: Baseline, 6, 12, and 24 months
Complication Rates
Time frame: Over 12 months.
Nursing Satisfaction Score
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guiren Hou, MB principal investigator
Changsha Fourth Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risk-Stratified Management Group in people with Hemodialysis and Heart Failure, run by Guiren Hou at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Major Adverse Cardiac Events (MACE) in Hemodialysis Patients with Heart Failure (time frame: From enrollment until first occurrence of any MACE component, assessed over 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.