Protecting Renal Function in Chronic Kidney Disease Patients with Isolated Nighttime Hypertension
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Institute of Hypertension
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Antihypertensive treatment with Arotinolol or Amlodipine or Clonidine
- Placebo-controlled group
Treatment groups
200 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov