Nighttime Valsartan in Hemodialysis Hypertension (NVHH)

July 19, 2018 updated by: Cheng Wang, Fifth Affiliated Hospital, Sun Yat-Sen University

Effect of Nighttime Valsartan on Prognosis of Nocturnal Hypertension Patients Undergoing Maintenance Hemodialysis

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

68

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
all-cause death
Time Frame: 5 years
death caused by all causes
5 years
cardiovascular death
Time Frame: 5 years
death caused by cardiovascular events, such as myocardial infarction, arrhythmia and heart failure
5 years
cerebrovascular death
Time Frame: 5 years
death caused by cerebral vascular events, such as stroke
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardio cerebral vascular events
Time Frame: 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
5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
cardiovascular structural abnormalities
Time Frame: 5 years
changes of carotid artery intima-media thickness and left ventricular mass index
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fifth Affiliated Hospital, Sun Yat-Sen University

Collaborators

Third Affiliated Hospital, Sun Yat-Sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2018

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

July 4, 2018

First Submitted That Met QC Criteria

July 19, 2018

First Posted (Actual)

July 20, 2018

Study Record Updates

Last Update Posted (Actual)

July 20, 2018

Last Update Submitted That Met QC Criteria

July 19, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Valsartan

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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