Cardiovascular Mortality Prediction in Maintenance Hemodialysis Patients | NCT07769190 | Trialant

CompletedObservationalUpdated Aug 17, 2026

Cardiovascular Mortality Prediction in Maintenance Hemodialysis Patients

Development of a Mortality Prediction Model for Patients Receiving Maintenance Hemodialysis

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT07769190
Lead Sponsor: Huashan HospitalOTHER
Overall Status: Completed
Study Type: Observational
Enrollment: 192Actual
Last Update Posted: Aug 17, 2026Actual
Start Date: Jul 16, 2021Actual
Primary Completion Date: Apr 21, 2022Actual
Completion Date: Apr 21, 2022Actual

Description

What the study is about and why it is being run, in the researchers' own words.

Official Title: Development of a Mortality Prediction Model for Patients Receiving Maintenance Hemodialysis
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

Conditions

The medical conditions and diseases this study investigates.

End-Stage Kidney Disease (ESKD)
Cardiovascular Disease
Secondary Hyperparathyroidism (SHPT)

Interventions

The treatments and procedures being evaluated in this study.

One-Year Serum Phosphate Target Achievement Rate
Parathyroidectomy

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Receipt of maintenance hemodialysis for at least 3 months.

Adequate ability to understand the study and communicate with the investigators.

Provision of written informed consent.

Exclusion Criteria:

Age younger than 18 years or older than 85 years.

Pregnancy or plans to become pregnant during the relevant study period.

Participation in another clinical research study within the preceding month.

Presence of a disease or clinical condition considered likely to materially affect serum phosphate concentrations.

Any other condition that, in the investigator's judgment, makes participation inappropriate.

Design

How the study is designed and how its participant groups are organized.

Observational Model: Cohort
Time Perspective: Prospective

Contacts

The people to reach with questions about this study or how to join it.

No central contacts

There are no central contacts for this study.

Locations

Where the study is run and whether each site is currently recruiting.

Huashan hospital, Fudan university

Shanghai, Shanghai Municipality 200040, China

Collaborators

The organizations and people involved in this study.

Lead Sponsor: Huashan HospitalOTHER

Similar Studies

Other registered studies that closely resemble this one.

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.