The Effect of Exercise on Blood Pressure Variability on Peritoneal Dialysis Patients (NCT07098923) | Clinical Trial Compass
CompletedNot Applicable
The Effect of Exercise on Blood Pressure Variability on Peritoneal Dialysis Patients
China55 participantsStarted 2024-02-02
Plain-language summary
In China, the chronic kidney disease (CKD) incidence rate is as high as 10.8%. Renal replacement therapy plays an critical role in the later stage of CKD and becomes mandatory, as end-stage renal disease (ESRD) is unavoidable in progressive CKD. Peritoneal dialysis (PD) has becoming an essential alternative treatment for patient with end-stage renal disease (ESRD). Hypertension is common among ESRD patients receiving PD treatment, with a prevalence rate of 80% -90%, It is major cause for cardiovascular related complications and deaths among ESRD patients. Therefore hypertension increases the cardiovascular disease risk among the patients of ESRD and at the same time plays an independent risk for the progression of ESRD. Most studies uses average blood pressure as a risk indicator, but in recent years, more evidence has shown that blood pressure variability (BPV), the degree of fluctuation of blood pressure for a long period, is an additional risk factors for cardiovascular events.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Dialysis time ≥ 3 months, a stable condition;
* Age ≥ 18 years old;
* Hypertension (blood pressure\>140 and/or 90 mmHg or currently under antihypertensive drugs), antihypertensive drugs was not changed or replaced during the complete trial;
* Patients with regular and sufficient peritoneal dialysis with kt/v\>1.7, high compliance, and voluntary participation.
Exclusion Criteria:
* Blood pressure more than - systolic blood pressure ≥ 180mmHg, diastolic blood pressure ≥ 110mmHg;
* Severe anaemia Hb ≤ 60g;
* Cardiac function Class IV - In accordance with The New York Heart Association classification system, patients with severe cardiac disease resulting in inability to perform any physical activity without discomfort (If any physical activity is undertaken, discomfort is increased) or symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest.
* Using erythropoietin;
* There have been recent acute cardiovascular and cerebrovascular events, including vascular embolism, surgery, trauma, etc.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference between the coefficient of variation of mean daytime Systolic Blood Pressure from the baseline to the end of the study
Timeframe: Baseline/12Weeks
2
Difference between the Coefficient of variation of mean daytime Diastolic Blood Pressure from the baseline to the end of the study
Timeframe: Baseline/12Weeks
3
Difference between the Coefficient of Variation of mean nighttime Systolic Blood Pressure from the baseline to the end of the study
Timeframe: Baseline/12Weeks
4
Difference between the Coefficient of Variation of mean nighttime Diastolic Blood Pressure from the baseline to the end of the study
Timeframe: Baseline/12Weeks
Trial details
NCT IDNCT07098923
SponsorThe Affiliated Hospital of Xuzhou Medical University