Nighttime Losartan in Continous Ambulatory Peritoneal Dialysis (NVCAPD)

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Cheng Wang，Fifth Affiliated Hospital, Sun Yat-Sen University

Tracking Information

First Submitted Date ^ICMJE

September 29, 2018

First Posted Date ^ICMJE

October 2, 2018

Last Update Posted Date

October 2, 2018

Actual Study Start Date ^ICMJE

December 1, 2018

Estimated Primary Completion Date

June 1, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

all-cause death[ Time Frame: 5 years ]

death caused by all causes

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

cardiovascular death[ Time Frame: 5 years ]
death caused by cardiovascular events, such as myocardial infarction, arrythmia and heart failure
cerebrovascular death[ Time Frame: 5 years ]
death caused by cerebral vascular events, such as stroke
cardiocerebral 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

Descriptive Information

Brief Title ^ICMJE

Nighttime Losartan in Continous Ambulatory Peritoneal Dialysis (NVCAPD)

Official Title ^ICMJE

Effect of Nighttime Losartan on Prognosis of Nocturnal Hypertension Patients Undergoing Continous Ambulatory Peritoneal Dialysis

Brief Summary

Hypertension is one of the most important independent risk factors for the prognosis of continous ambulatory peritoneal dialysis patients. The incident 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 is lack of evidence about its impact on prognosis in peritoneal dialysis 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 peritoneal dialysis patients with nocturnal hypertension. To this end, we collect continous ambulatory peritoneal dialysis patients with nocturnal hypertension, and propose a time selective use of losartan to intervene in nocturnal hypertension. By comparing the difference in the effects of losartan on the prognosis of maintenance peritoneal dialysis patients during the day or night, to further clarify the role of nocturnal hypertension in the prognosis of maintenance peritoneal dialysis patients, whether controlling nocturnal hypertension can improve the prognosis of maintenance peritoneal dialysis patients. The completion of study will optimize the prevention and treatment of hypertension in maintenance peritoneal dialysis patients, and provide an evidence for precise prevention and treatment of hypertension in maintenance peritoneal dialysis patients.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Drug: Losartan
Different time of taking medicine

Study Arms

Experimental: nighttime group
patients with nocturnal hypertension taking losartan at nighttime
Active Comparator: daytime group
patients with nocturnal hypertension taking losartan at daytime

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

December 1, 2023

Estimated Primary Completion Date

June 1, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: 1. Age over 18 years old and <75 years. 2. Diagnosed as chronic kidney disease 5th stage in accordance with the KDIGO guide 2012 (egfr < 15 ml/ (min 1.73m2)). 3. Accept 3-5 bags daily, continous ambulatory peritoneal dialysis for >3 months. 4. Ambulatory blood pressure monitoring indicates nighttime systolic blood pressure (SBP) > 120mmHg and / or diastolic blood pressure (DBP) > 70mmHg. Exclusion Criteria: 1. Night learning or work, irregular rest for a long time. 2. Moderate and severe edema in difficult to correct 3. Persistent atrial fibrillation. 4. Severe anemia and severe dystrophy. 5. Patients with postural hypotension or symptomatic hypotension. 6. Severe side effects or contraindications of valsartan treatment. 7. Treatment of corticosteroids or other hormones at present. 8. Unable to cooperate or unable to tolerate ambulatory blood pressure monitoring. 9. Ineffective ambulatory blood pressure data. 10. 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. 11. In the first 3 months before admission, there were obvious cardiovascular and cerebrovascular diseases such as coronary syndrome, myocardial infarction or stroke. 12. There were complications such as vascular disease, infection and bleeding within 1 months.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Cheng Wang，Fifth Affiliated Hospital, Sun Yat-Sen University

Study Sponsor ^ICMJE

Fifth Affiliated Hospital, Sun Yat-Sen University

Collaborators ^ICMJE

Investigators ^ICMJE

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

PRS Account

Fifth Affiliated Hospital, Sun Yat-Sen University

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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