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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
Fifth Affiliated Hospital, Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension;Nephropathy focused on measuring Nocturnal Hypertension; Hemodialysis; Valsartan

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age over 18 years old and <75 years.
  2. Diagnosed as CKD 5th stage in accordance with the kdigo guide 2012 (egfr < 15 ml/ (min 1.73m2)).
  3. Accept 2-3 times a week, 4h regular hemodialysis for >3 months.
  4. Ambulatory blood pressure monitoring indicates nighttime blood pressure systolic blood pressure(SBP) > 120mmHg and / or diastolic blood pressure(DBP) > 70mmHg.

Exclusion Criteria:

  1. Stop hemodialysis longer than one month more than 2 times.
  2. Night learning or work, irregular rest for a long time.
  3. Overloading capacity, ultrafiltration volume of each treatment >7% dry weight.
  4. Persistent atrial fibrillation.
  5. Severe anemia and severe dystrophy.
  6. Patients with postural hypotension or symptomatic hypotension.
  7. Severe side effects or contraindications of valsartan treatment.
  8. Treatment of corticosteroids or other hormones at present.
  9. Unable to cooperate or unable to tolerate ambulatory blood pressure monitoring.
  10. Ineffective ambulatory blood pressure data.
  11. 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.
  12. In the first 3 months before admission, there were obvious cardiovascular and cerebrovascular diseases such as coronary syndrome, myocardial infarction or stroke.
  13. 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

    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
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    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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