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NVHH: Nighttime Valsartan in Hemodialysis Hypertension

Sponsor
Fifth Affiliated Hospital, Sun Yat-Sen University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT03594825
Collaborator
Third Affiliated Hospital, Sun Yat-Sen University (Other)
68
Enrollment
2
Arms
61
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
68 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Nighttime Valsartan on Prognosis of Nocturnal Hypertension Patients Undergoing Maintenance Hemodialysis
Anticipated Study Start Date :
Nov 1, 2018
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: nighttime group

patients with nocturnal hypertension taking valsartan at nighttime

Drug: Valsartan
Different time of taking medicine
Other Names:
  • Novartis

    		•
    Active Comparator: daytime group

    patients with nocturnal hypertension taking valsartan at daytime

    Drug: Valsartan
    Different time of taking medicine
    Other Names:
  • Novartis

    		•

    Outcome Measures

    Primary Outcome Measures

    1. all-cause death [5 years]

      death caused by all causes

    2. cardiovascular death [5 years]

      death caused by cardiovascular events, such as myocardial infarction, arrhythmia and heart failure

    3. cerebrovascular death [5 years]

      death caused by cerebral vascular events, such as stroke

    Secondary Outcome Measures

    1. Cardio cerebral vascular events [5 years]

      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

    Other Outcome Measures

    1. cardiovascular structural abnormalities [5 years]

      changes of carotid artery intima-media thickness and left ventricular mass index

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Fifth Affiliated Hospital, Sun Yat-Sen University
    • Third Affiliated Hospital, Sun Yat-Sen University

    Investigators

    • Principal Investigator: Cheng Wang, Director, Nephrology Department, the Fifth Affiliated Hospital of Sun Yat-sen University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Cheng Wang, Director of Nephrology, Fifth Affiliated Hospital, Sun Yat-Sen University
    ClinicalTrials.gov Identifier:
    NCT03594825
    Other Study ID Numbers:
    • Valsartan
    First Posted:
    Jul 20, 2018
    Last Update Posted:
    Jul 20, 2018
    Last Verified:
    Jul 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Cheng Wang, Director of Nephrology, Fifth Affiliated Hospital, Sun Yat-Sen University
    Nocturnal Hypertension; Hemodialysis; Valsartan
    Additional relevant MeSH terms:
    Hypertension
    Valsartan

    Study Results

    No Results Posted as of Jul 20, 2018