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

January 15, 2025 updated by: Yan Li, Shanghai Institute of Hypertension

Protection of Renal Function by Antihypertensive Treatment in Patients with Chronic Kidney Disease and Isolated Nighttime Hypertension

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anti-hypertensive treatment group
The patients will be treated with Arotinolol and/or Amlodipine and/or Clonidine.
Drug: Antihypertensive treatment with Arotinolol or Amlodipine or Clonidine
Participants will receive Almar 10 mg orally once daily between 8:00 PM and midnight. At the subsequent visit, if nocturnal blood pressure remains above the target of <120/70 mmHg, Amlodipine Besylate will be added at a dose of 2.5 mg to 5 mg orally once daily. Should nocturnal blood pressure still not achieve the target at the following visit, Clonidine Hydrochloride 75 µg will be added to the regimen. The target for nocturnal blood pressure control is set at <120/70 mmHg. For participants whose clinic blood pressure exceeds 140/90 mmHg, an unscheduled visit will be arranged within one month. If elevated clinic blood pressure persists during this visit, a 24-hour Ambulatory Blood Pressure Monitoring (ABPM) will be conducted. If the ABPM results indicate daytime blood pressure ≥135/85 mmHg, open-label add-on antihypertensive therapy will be initiated, prioritizing the use of antihypertensive medications outside of the study drugs to achieve blood pressure control.
Placebo Comparator: Control group
Placebo was used in the control group.
Drug: Placebo-controlled group
Participants are treated with corresponding placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in renal function from baseline after 1 year of treatment as assessed by EPI-estimated glomerular filtration rate (eGFR)
Time Frame: 1 year
1 year
Change in urine protein from baseline after 1 and 2 years of treatment as assessed by urinary albumin-to-creatinine ratio(UACR)
Time Frame: 1 and 2 years
1 and 2 years
50% decrease of albumin-to-creatinine ratio (UACR) from baseline after 1 and 2 years of treatment
Time Frame: 1 and 2 years
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%.
Time Frame: 1 and 2 years
1 and 2 years
Incidence of sustained EPI-estimated glomerular filtration rate (eGFR) < 15 ml/min/1.73 m²
Time Frame: 1 and 2 years
1 and 2 years
Incidence of cardiovascular endpoints including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or heart failure hospitalization
Time Frame: 1 and 2 years
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
Time Frame: 1 and 2 years
1 and 2 years
Changes in pulse wave velocity (PWV) after 1 and 2 years of treatment from baseline
Time Frame: 1 and 2 years
1 and 2 years
Incidence of mortality including all-cause, cardiovascular-related, and renal-related.
Time Frame: 1 and 2 years
1 and 2 years
Changes in office and ambulatory blood pressure levels after 1 and 2 years of treatment from baseline
Time Frame: 1 and 2 years
1 and 2 years
Hypotension-related adverse events
Time Frame: 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].
1 and 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Institute of Hypertension

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 30, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

January 3, 2025

First Submitted That Met QC Criteria

January 15, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 15, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRECISE trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Nocturnal Hypertension

Clinical Trials on Antihypertensive treatment with Arotinolol or Amlodipine or Clonidine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe