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Clinical Trial Details

Trial ID: L0618
Source ID: NCT06780865
Associated Drug: Antihypertensive Treatment With Arotinolol Or Amlodipine Or Clonidine
Title: Protecting Renal Function in Chronic Kidney Disease Patients with Isolated Nighttime Hypertension
Acronym: PRECISE
Status: NOT_YET_RECRUITING
Study Results: NO
Results:
Conditions: Chronic Kidney Disease(CKD)|Nocturnal Hypertension
Interventions: DRUG: Antihypertensive treatment with Arotinolol or Amlodipine or Clonidine|DRUG: Placebo-controlled group
Outcome Measures: Primary: Change in renal function from baseline after 2 year of treatment as assessed by EPI-estimated glomerular filtration rate (eGFR), 2 years | Secondary: Change in renal function from baseline after 1 year of treatment as assessed by EPI-estimated glomerular filtration rate (eGFR), 1 year|Change in urine protein from baseline after 1 and 2 years of treatment as assessed by urinary albumin-to-creatinine ratio(UACR), 1 and 2 years|50% decrease of albumin-to-creatinine ratio (UACR) from baseline after 1 and 2 years of treatment, 1 and 2 years|Incidence of kidney composite endpoint including end-stage renal disease (ESRD), kidney replacement therapy, or sustained EPI-estimated glomerular filtration rate (eGFR) decline ≥ 40%., 1 and 2 years|Incidence of sustained EPI-estimated glomerular filtration rate (eGFR) < 15 ml/min/1.73 m², 1 and 2 years|Incidence of cardiovascular endpoints including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or heart failure hospitalization, 1 and 2 years|Changes in cardiac injury after 1 and 2 years of treatment from baseline as assessed by left ventricular mass index or E/E' or cardiac troponin, 1 and 2 years|Changes in pulse wave velocity (PWV) after 1 and 2 years of treatment from baseline, 1 and 2 years|Incidence of mortality including all-cause, cardiovascular-related, and renal-related., 1 and 2 years|Changes in office and ambulatory blood pressure levels after 1 and 2 years of treatment from baseline, 1 and 2 years|Hypotension-related adverse events, dizziness, falls, office blood pressure below 90/60 mmHg, orthostatic hypotension (blood pressure drop exceeding 20/10 mmHg within 3 minutes of standing compared to sitting), and acute kidney injury \[serum creatinine increase ≥0.3 mg/dl (≥26.5 μmol/L) within 48 hours; or serum creatinine rising to ≥1.5 times baseline value within 7 days; or urine output \<0.5 mL/(kg·h) for ≥ 6 hours\]., 1 and 2 years
Sponsor/Collaborators: Sponsor: Shanghai Institute of Hypertension
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 200
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2025-01-30
Completion Date: 2028-12-31
Results First Posted:
Last Update Posted: 2025-01-17
Locations:
URL: https://clinicaltrials.gov/show/NCT06780865