Nighttime Valsartan in Hemodialysis Hypertension (NVHH)
Primary Purpose
Hypertension;Nephropathy
Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Valsartan
Sponsored by

About this trial
This is an interventional treatment trial for Hypertension;Nephropathy focused on measuring Nocturnal Hypertension; Hemodialysis; Valsartan
Eligibility Criteria
Inclusion Criteria:
- Age over 18 years old and <75 years.
- Diagnosed as CKD 5th stage in accordance with the kdigo guide 2012 (egfr < 15 ml/ (min 1.73m2)).
- Accept 2-3 times a week, 4h regular hemodialysis for >3 months.
- Ambulatory blood pressure monitoring indicates nighttime blood pressure systolic blood pressure(SBP) > 120mmHg and / or diastolic blood pressure(DBP) > 70mmHg.
Exclusion Criteria:
- Stop hemodialysis longer than one month more than 2 times.
- Night learning or work, irregular rest for a long time.
- Overloading capacity, ultrafiltration volume of each treatment >7% dry weight.
- Persistent atrial fibrillation.
- Severe anemia and severe dystrophy.
- Patients with postural hypotension or symptomatic hypotension.
- Severe side effects or contraindications of valsartan treatment.
- Treatment of corticosteroids or other hormones at present.
- Unable to cooperate or unable to tolerate ambulatory blood pressure monitoring.
- Ineffective ambulatory blood pressure data.
- The clinical data were incomplete during the treatment period; end-point events occurred within 6 months or follow-up time was less than 6 months.
- In the first 3 months before admission, there were obvious cardiovascular and cerebrovascular diseases such as coronary syndrome, myocardial infarction or stroke.
- There were complications such as vascular disease, infection and bleeding within 1 months.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
nighttime group
daytime group
Arm Description
patients with nocturnal hypertension taking valsartan at nighttime
patients with nocturnal hypertension taking valsartan at daytime
Outcomes
Primary Outcome Measures
all-cause death
death caused by all causes
cardiovascular death
death caused by cardiovascular events, such as myocardial infarction, arrhythmia and heart failure
cerebrovascular death
death caused by cerebral vascular events, such as stroke
Secondary Outcome Measures
Cardio cerebral vascular events
cardiovascular and cerebrovascular events that require hospitalization and lead to death or non death, including myocardial infarction, heart failure, stroke, vascular reconstruction, peripheral vascular disease, and non-traumatic amputation
Full Information
NCT ID
NCT03594825
First Posted
July 4, 2018
Last Updated
July 19, 2018
Sponsor
Fifth Affiliated Hospital, Sun Yat-Sen University
Collaborators
Third Affiliated Hospital, Sun Yat-Sen University
1. Study Identification
Unique Protocol Identification Number
NCT03594825
Brief Title
Nighttime Valsartan in Hemodialysis Hypertension
Acronym
NVHH
Official Title
Effect of Nighttime Valsartan on Prognosis of Nocturnal Hypertension Patients Undergoing Maintenance Hemodialysis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2018 (Anticipated)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fifth Affiliated Hospital, Sun Yat-Sen University
Collaborators
Third Affiliated Hospital, Sun Yat-Sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hypertension is one of the most important independent risk factors for the prognosis of maintenance hemodialysis patients. The incidence rate is high and the control rate is low. Nocturnal hypertension has been paid more attention in recent years. Compared to daytime blood pressure, nocturnal blood pressure is an independent and efficient prognostic indicator of hypertensive deaths and cardiovascular events, but it's lack of evidence about its impact on prognosis in hemodialysis patients and the effective treatment program. Our previous cohort study suggests that the incidence of nocturnal hypertension in patients with chronic kidney disease is up to 71.22%, with a significant increase as the decline of renal function, and more severe target organ damage in patients with nocturnal hypertension: the decrease of glomerular filtration rate, left ventricular hypertrophy, and the increase of all cause death and cardiovascular death. Our small sample size study show that night time antihypertensive drugs can better control blood pressure and delay the development of left ventricular hypertrophy. These preliminary results suggest that nocturnal hypertension is closely related to the prognosis of chronic renal disease. Taking antihypertensive drugs at night is one of the options for controlling nocturnal hypertension. However, it is not clear whether taking antihypertensive drugs at night can improve the prognosis of maintenance hemodialysis patients with nocturnal hypertension. To this end, we collect maintenance hemodialysis patients with nocturnal hypertension, and propose a time selective use of valsartan to intervene in nocturnal hypertension. By comparing the differences in the effects of valsartan on the prognosis of maintenance hemodialysis patients during the day or night, to further clarify the role of nocturnal hypertension in the prognosis of maintenance hemodialysis patients, whether controlling nocturnal hypertension can improve the prognosis of maintenance hemodialysis patients. The completion of the study will optimize the prevention and treatment of hypertension in maintenance hemodialysis patients, and provide an evidence for precise prevention and treatment of hypertension in maintenance hemodialysis patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension;Nephropathy
Keywords
Nocturnal Hypertension; Hemodialysis; Valsartan
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
nighttime group
Arm Type
Experimental
Arm Description
patients with nocturnal hypertension taking valsartan at nighttime
Arm Title
daytime group
Arm Type
Active Comparator
Arm Description
patients with nocturnal hypertension taking valsartan at daytime
Intervention Type
Drug
Intervention Name(s)
Valsartan
Other Intervention Name(s)
Novartis
Intervention Description
Different time of taking medicine
Primary Outcome Measure Information:
Title
all-cause death
Description
death caused by all causes
Time Frame
5 years
Title
cardiovascular death
Description
death caused by cardiovascular events, such as myocardial infarction, arrhythmia and heart failure
Time Frame
5 years
Title
cerebrovascular death
Description
death caused by cerebral vascular events, such as stroke
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Cardio cerebral vascular events
Description
cardiovascular and cerebrovascular events that require hospitalization and lead to death or non death, including myocardial infarction, heart failure, stroke, vascular reconstruction, peripheral vascular disease, and non-traumatic amputation
Time Frame
5 years
Other Pre-specified Outcome Measures:
Title
cardiovascular structural abnormalities
Description
changes of carotid artery intima-media thickness and left ventricular mass index
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age over 18 years old and <75 years.
Diagnosed as CKD 5th stage in accordance with the kdigo guide 2012 (egfr < 15 ml/ (min 1.73m2)).
Accept 2-3 times a week, 4h regular hemodialysis for >3 months.
Ambulatory blood pressure monitoring indicates nighttime blood pressure systolic blood pressure(SBP) > 120mmHg and / or diastolic blood pressure(DBP) > 70mmHg.
Exclusion Criteria:
Stop hemodialysis longer than one month more than 2 times.
Night learning or work, irregular rest for a long time.
Overloading capacity, ultrafiltration volume of each treatment >7% dry weight.
Persistent atrial fibrillation.
Severe anemia and severe dystrophy.
Patients with postural hypotension or symptomatic hypotension.
Severe side effects or contraindications of valsartan treatment.
Treatment of corticosteroids or other hormones at present.
Unable to cooperate or unable to tolerate ambulatory blood pressure monitoring.
Ineffective ambulatory blood pressure data.
The clinical data were incomplete during the treatment period; end-point events occurred within 6 months or follow-up time was less than 6 months.
In the first 3 months before admission, there were obvious cardiovascular and cerebrovascular diseases such as coronary syndrome, myocardial infarction or stroke.
There were complications such as vascular disease, infection and bleeding within 1 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianting Ke, Doctor
Phone
0086 756 2528953
Email
kjt1997@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheng Wang, Director
Organizational Affiliation
Nephrology Department, the Fifth Affiliated Hospital of Sun Yat-sen University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Nighttime Valsartan in Hemodialysis Hypertension
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