Cardiovascular Disease, End-Stage Kidney Disease (ESKD), Secondary Hyperparathyroidism (SHPT)
Conditions
Keywords
Maintenance Hemodialysis, Cardiovascular Mortality, Serum Phosphate
Brief summary
This prospective, single-center observational cohort study evaluates cardiovascular mortality risk in adults receiving maintenance hemodialysis. During the first year after enrollment, four scheduled assessments are used to characterize demographic factors, dialysis treatment, medication use, routine laboratory measures, and the proportion of serum phosphate measurements within the protocol-defined target range. Participants are subsequently followed for cardiovascular mortality. The study evaluates factors associated with serum phosphate target achievement and develops a cardiovascular mortality prediction model in the overall cohort, with a prespecified subgroup analysis among participants who undergo parathyroidectomy. No treatment or procedure is assigned by the study investigators.
Detailed description
This is a prospective observational cohort study conducted at the Hemodialysis Center of Huashan Hospital, Fudan University. Adults aged 18 to 85 years who have received maintenance hemodialysis for at least 3 months and meet the eligibility criteria are enrolled after providing written informed consent. During the first year after enrollment, four scheduled assessments are performed. Data collected include demographic and clinical characteristics, dialysis treatment parameters, medication use, complete blood count, routine biochemical measurements, immunologic measurements, and other clinically relevant indicators. The principal exposure is the one-year serum phosphate target achievement rate, defined as the number of evaluable serum phosphate measurements within the protocol-defined target range divided by the total number of evaluable scheduled measurements during the one-year assessment period. Following the one-year exposure-assessment period, participants are followed for cardiovascular mortality for up to 5 years. The primary objective is to evaluate the association between the one-year serum phosphate target achievement rate and cardiovascular mortality and to develop a cardiovascular mortality prediction model. Secondary objectives include identifying factors associated with serum phosphate target achievement and developing a mortality prediction model in the prespecified subgroup of participants who undergo parathyroidectomy as part of routine clinical care. Descriptive analyses and appropriate parametric or nonparametric tests are used to summarize and compare participant characteristics. Multivariable regression is used to evaluate factors associated with serum phosphate target achievement. Cox proportional hazards regression and prespecified statistical or machine-learning methods are used to evaluate cardiovascular mortality risk and develop prognostic models. All statistical tests are two-sided with an alpha level of 0.05. No study-specific treatment is assigned, and clinical management is determined independently by the treating physicians.
Interventions
OTHEROne-Year Serum Phosphate Target Achievement Rate
The one-year serum phosphate target achievement rate is calculated as the number of evaluable scheduled serum phosphate measurements within the protocol-defined target range divided by the total number of evaluable scheduled measurements during the first year after enrollment. Four scheduled assessments are planned. Serum phosphate management is determined by routine clinical care and is not assigned by the study investigators.
PROCEDUREParathyroidectomy
Parathyroidectomy received as part of routine clinical care is recorded for prespecified subgroup analysis. The decision to perform parathyroidectomy is made by the treating clinical team and is not assigned by the study investigators.
Sponsors
Huashan Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Receipt of maintenance hemodialysis for at least 3 months. 2. Adequate ability to understand the study and communicate with the investigators. 3. Provision of written informed consent.
Exclusion criteria
1. Age younger than 18 years or older than 85 years. 2. Pregnancy or plans to become pregnant during the relevant study period. 3. Participation in another clinical research study within the preceding month. 4. Presence of a disease or clinical condition considered likely to materially affect serum phosphate concentrations. 5. Any other condition that, in the investigator's judgment, makes participation inappropriate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular Mortality | Up to 5 years after completion of the 1-year exposure-assessment period | Occurrence and date of death attributed to cardiovascular disease during follow-up, ascertained through study follow-up and available clinical or death records. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| One-Year Serum Phosphate Target Achievement Rate | During the first year after enrollment | The number of evaluable scheduled serum phosphate measurements within the protocol-defined target range divided by the total number of evaluable scheduled measurements during the first year after enrollment. Four scheduled assessments are planned for each participant. |
| Mortality in the Parathyroidectomy Subgroup | Up to 5 years after completion of the 1-year exposure-assessment period | Occurrence and date of death during follow-up among participants who undergo parathyroidectomy as part of routine clinical care. These data are used for prespecified subgroup prognostic modeling. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORJing Chen
Huashan Hospital
Outcome results
None listed