Nighttime Valsartan in Hemodialysis Hypertension

NCT ID: NCT03594825

Last Updated: 2018-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-30
• Study Completion Date: 2023-12-31

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.

Conditions

Hypertension;Nephropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

nighttime group

patients with nocturnal hypertension taking valsartan at nighttime

Group Type: EXPERIMENTAL

Valsartan

Intervention Type: DRUG

Different time of taking medicine

daytime group

patients with nocturnal hypertension taking valsartan at daytime

Group Type: ACTIVE_COMPARATOR

Valsartan

Intervention Type: DRUG

Different time of taking medicine

Interventions

Valsartan

Different time of taking medicine

Intervention Type: DRUG

Other Intervention Names

Novartis

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: collaborator

Fifth Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Cheng Wang

Director of Nephrology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cheng Wang, Director

Role: PRINCIPAL_INVESTIGATOR

Nephrology Department, the Fifth Affiliated Hospital of Sun Yat-sen University

Central Contacts

Jianting Ke, Doctor

Role: CONTACT

kjt1997@163.com

0086 756 2528953

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Other Identifiers

Valsartan

Identifier Type: -

Identifier Source: org_study_id