Nighttime Valsartan in Hemodialysis Hypertension

NCT03594825 | Unknown Phase 4

• 1 other identifier: Valsartan
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

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

Keywords

Nocturnal Hypertension; Hemodialysis; Valsartan

Outcome Measures

Primary Outcomes (3)

• all-cause death

  death caused by all causes

  5 years

• cardiovascular death

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

  5 years

• cerebrovascular death

  death caused by cerebral vascular events, such as stroke

  5 years

Secondary Outcomes (1)

• Cardio cerebral vascular events

  5 years

Other Outcomes (1)

• cardiovascular structural abnormalities

  5 years

Study Arms (2)

nighttime group

EXPERIMENTAL

patients with nocturnal hypertension taking valsartan at nighttime

Drug: Valsartan

daytime group

ACTIVE COMPARATOR

patients with nocturnal hypertension taking valsartan at daytime

Drug: Valsartan

Interventions

Valsartan DRUG

Different time of taking medicine

Also known as: Novartis

daytime group; nighttime group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fifth Affiliated Hospital, Sun Yat-Sen University: lead
• Third Affiliated Hospital, Sun Yat-Sen University: collaborator

Related Publications (19)

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  PMID: 18028170 BACKGROUND

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  PMID: 24359485 BACKGROUND

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  PMID: 21705406 BACKGROUND

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  PMID: 9431857 BACKGROUND

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• Cuspidi C, Sala C, Valerio C, Negri F, Mancia G. Nocturnal blood pressure in untreated essential hypertensives. Blood Press. 2011 Dec;20(6):335-41. doi: 10.3109/08037051.2011.587280. Epub 2011 Jun 9.

  PMID: 21651423 BACKGROUND

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  PMID: 17460384 BACKGROUND

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  PMID: 22378470 BACKGROUND

• Clement DL, De Buyzere ML, De Bacquer DA, de Leeuw PW, Duprez DA, Fagard RH, Gheeraert PJ, Missault LH, Braun JJ, Six RO, Van Der Niepen P, O'Brien E; Office versus Ambulatory Pressure Study Investigators. Prognostic value of ambulatory blood-pressure recordings in patients with treated hypertension. N Engl J Med. 2003 Jun 12;348(24):2407-15. doi: 10.1056/NEJMoa022273.

  PMID: 12802026 BACKGROUND

• Hansen TW, Li Y, Boggia J, Thijs L, Richart T, Staessen JA. Predictive role of the nighttime blood pressure. Hypertension. 2011 Jan;57(1):3-10. doi: 10.1161/HYPERTENSIONAHA.109.133900. Epub 2010 Nov 15.

  PMID: 21079049 BACKGROUND

• Sarafidis PA, Persu A, Agarwal R, Burnier M, de Leeuw P, Ferro C, Halimi JM, Heine G, Jadoul M, Jarraya F, Kanbay M, Mallamaci F, Mark PB, Ortiz A, Parati G, Pontremoli R, Rossignol P, Ruilope L, Van der Niepen P, Vanholder R, Verharr MC, Wiecek A, Wuerzner G, London GM, Zoccali C. Hypertension in dialysis patients: a consensus document by the European Renal and Cardiovascular Medicine (EURECA-m) working group of the European Renal Association - European Dialysis and Transplant Association (ERA-EDTA) and the Hypertension and the Kidney working group of the European Society of Hypertension (ESH). J Hypertens. 2017 Apr;35(4):657-676. doi: 10.1097/HJH.0000000000001283.

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  PMID: 18653268 BACKGROUND

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  PMID: 23282124 BACKGROUND

MeSH Terms

Conditions

Hypertensive Nephropathy

Interventions

Valsartan; lactitol

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Officials

• Cheng Wang, Director

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianting Ke, Doctor

CONTACT

0086 756 2528953; kjt1997@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Nephrology

Study Record Dates

• First Submitted: July 4, 2018
• First Posted: July 20, 2018
• Study Start: November 1, 2018
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: July 20, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share