Hypertension Clinical Trial
Verified date | October 2011 |
Source | Capital Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Ethics Committee |
Study type | Interventional |
Unfavorably high sodium intakes remain prevalent around the world. A negative sodium
gradient in hemodialysis treatment results in absolute sodium removal via diffusive
transport of sodium from the blood to the dialysate, and it may be a potentially useful tool
to improve sodium loading due to excess dietary sodium intake.
The purpose of this study is to determine whether a in small negative sodium gradient could
improve blood pressure level, arterial stiffness and left ventricular hypertrophy in
hypertensive hemodialysis patients, who had been achieving and maintaining their dry weight
assessed by bioimpedance spectroscopy.
Status | Completed |
Enrollment | 16 |
Est. completion date | September 2011 |
Est. primary completion date | February 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - They had been on HD for more than 1 year. - They had had no clinical cardiovascular disease during 3 months preceding entry into the study, with left ventricular ejection fraction over 40%. - Their residual daily urine output was lower than 100 ml/day. - They had achieved their dry weight assessed by bioimpedance technique and clinical examination for at least 3 months. - A mean interdialytic ambulatory BP of >135/85 mmHg. - Averaging the last six available monthly pre-dialysis plasma sodium concentrations over the preceding 12 months >138mmol/l. Exclusion Criteria: - They had known acute inflammatory event, malignant disease, and the serum albumine<30g/l. - They were diabetic and hypotension prone. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Department of Nephrology, Chao-Yang Hospital, Capital Medical University | Beijing |
Lead Sponsor | Collaborator |
---|---|
Capital Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in 44-hour ambulatory systolic and diastolic blood pressure | The change is calculated as the 4 months minus baseline, and the 12 months minus baseline | Baseline, 4 months, and 12 months | Yes |
Secondary | Changes in aortic pulse wave velocity and left ventricular mass index | The change is calculated as the 4 months minus baseline, and the 12 months minus baseline | Baseline, 4 months, and 12 months | Yes |
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