Protecting Renal Function in Chronic Kidney Disease Patients with Isolated Nighttime Hypertension

Not Applicable

Not yet recruiting

• Conditions: Chronic Kidney Disease(CKD); Nocturnal Hypertension
• Interventions: Drug: Antihypertensive treatment with Arotinolol or Amlodipine or Clonidine; Drug: Placebo-controlled group

• Registration Number: NCT06780865
• Lead Sponsor: Shanghai Institute of Hypertension

Brief Summary

Hypertension guidelines recommend the application of ambulatory blood pressure monitoring in the diagnosis and treatment of patients with hypertension. Subtypes of hypertension such as nocturnal hypertension can be found through ambulatory blood pressure monitoring. Previous studies have reported that the prevalence of nocturnal hypertension, even isolated nocturnal hypertension, is higher in patients with chronic kidney disease, and it is associated with adverse events such as cardiovascular events and progression of renal dysfunction. However, the benefit of controlling nocturnal hypertension in patients with chronic kidney disease is unclear. In this study, a total of 200 patients with chronic kidney disease and isolated nocturnal hypertension will be enrolled. Patients will be randomly divided into two treatment groups: the active antihypertensive treatment group and the placebo treatment group (1:1). The antihypertensive treatment group will be treated with arotinolol or amlodipine and clonidine to control nocturnal blood pressure, while the control group will be treated with the corresponding placebos. Randomized patients will be followed up for 2 years to evaluate the effect of controlling isolated nocturnal hypertension on the progression of chronic kidney disease in terms of EPI-estimated glomerular filtration rate (eGFR) decline and change in proteinuria.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-03
• Study First Submitted QC: 2025-01-15
• Last Update Submitted: 2025-01-15
• Study First Posted: 2025-01-17
• Last Update Posted: 2025-01-17
• Study Start: 2025-01-30
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Participants must be 18 years of age or older. All genders are eligible;
• Confirmed diagnosis of Chronic Kidney Disease (CKD) according to KDIGO. guidelines;
• UACR < 30 mg/g (3.4 mg/mmol) and eGFR between 20-44 mL/min/1.73 m²; or UACR between 30-300 mg/g (3.4-33.9 mg/mmol) and eGFR between 20-59 mL/min/1.73 m²; or UACR between 300-5000 mg/g (33.9-565 mg/mmol) and eGFR > 20 mL/min/1.73 m² (CKD-EPI equation).
• Office blood pressure measurements below 140/90 mmHg at both screening visits;
• Daytime ambulatory blood pressure < 135/85 mmHg and nighttime systolic blood pressure ≥ 120 mmHg or diastolic blood pressure ≥ 70 mmHg;
• No use of corticosteroids, immunosuppressants, or biologic agents for at least one month prior to enrollment;

Exclusion Criteria

• Presence of acute kidney injury or acute renal failure;
• History of kidney transplantation;
• Presence of severe arrhythmias, including severe atrial fibrillation, atrioventricular (AV) block, sinoatrial (SA) block, sinus bradycardia, malignant AV node reentrant tachycardia syndrome;
• Secondary hypertension related to suspected or confirmed renal artery stenosis or adrenal gland disorders;
• Poor glycemic control (HbA1c > 12%);
• Orthostatic hypotension (a decrease in blood pressure of >20/10 mmHg within 3 minutes of standing from a sitting position);
• Women who are pregnant or breastfeeding at the time of enrollment, or not employing contraception of reproductive age;
• NYHA (New York Heart Association) Class III-IV congestive heart failure at the time of enrollment;
• History of myocardial infarction, unstable angina, acute heart failure, stroke, transient ischemic attack (TIA), or cerebral hemorrhage within the 12 weeks prior to enrollment;
• Underwent coronary revascularization (Percutaneous Coronary Intervention [PCI] or Coronary Artery Bypass Grafting [CABG]), or valve repair/replacement within the 12 weeks prior to enrollment, or planned to undergo any of the aforementioned surgical procedures after randomization;
• Any other serious diseases outside the renal and cardiovascular domains, including but not limited to malignancies, with an expected survival of less than 2 years based on the investigator's clinical judgment;
• Presence of active malignancy requiring pharmacological treatment;
• AST (Aspartate Aminotransferase) or ALT (Alanine Aminotransferase) levels >3 times the upper limit of normal (ULN);
• Total bilirubin >2 times ULN. Patients with Gilbert's syndrome who exhibit isolated bilirubin elevation do not need to be excluded;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anti-hypertensive treatment group	Antihypertensive treatment with Arotinolol or Amlodipine or Clonidine	The patients will be treated with Arotinolol and/or Amlodipine and/or Clonidine.
Control group	Placebo-controlled group	Placebo was used in the control group.

Primary Outcome Measures

Name	Time	Method
Change in renal function from baseline after 2 year of treatment as assessed by EPI-estimated glomerular filtration rate (eGFR)	2 years

Secondary Outcome Measures

Name	Time	Method
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
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
Hypotension-related adverse events	1 and 2 years	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 \[serum creatinine increase ≥0.3 mg/dl (≥26.5 μmol/L) within 48 hours; or serum creatinine rising to ≥1.5 times baseline value within 7 days; or urine output \<0.5 mL/(kg·h) for ≥ 6 hours\].