Effect of Arotinolol Hydrochloride on Cardiovascular Events in Hypertensive Haemodialysis Patients

Study Overview
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Brief Summary
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The purpose of this study is to ascertain whether Arotinolol Hydrochloride reduces mortality and cardiovascular events in chronic kidney disease stage 5 patients with hypertension.

Official Title
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Effect of Arotinolol Hydrochloride on Cardiovascular Events in Hypertensive Haemodialysis Patients: An Open Labelled, Randomized, Multicentered, Controlled Trial

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Drug: Arotinolol Hydrochloride
* Drug: Non arotinolol group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged between 18-75 years-old; Chronic kidney disease stage 5 with haemodialysis treatment for 2 months; Patients with blood pressure≥140/90 mmHg after receiving 2 or 3 antihypertensive medications for 2 weeks; Patients who receiving alfa or beta blockers will be washed out for 2 weeks; Written informed consent Exclusion Criteria: Unstable angina, myocardial infarction, symptomatic or continuous arrhythmia, cardiosurgery in the last 2 months; Patients who taking class I antiarrhythmic drugs; Resting heart rate less than 60; Patients with systolic pressure less than 90 mmHg; Patients with chronic obstructive pulmonary disease and asthma; Patients with cerebral infarction in the last 2 weeks; Severe disorders of liver function; Allergy to the arotinolol; Patients who planning to have kidney transplantation in the near future; Pregnancy and breast-feeding; Malignant tumor

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arotinolol Hydrochloride<br>Antihypertensive medications plus arotinolol hydrochloride | Drug: Arotinolol Hydrochloride<br>* Antihypertensive medications plus arotinolol hydrochloride, dosage of arotinolol hydrochloride from 2.5mg bid, 2 days later increased to 5mg bid or 10mg bid, for 18 months<br>* Other names: Almarl;|
| Placebo Comparator: Non arotinolol group<br>Antihypertensive medications without arotinolol hydrochloride | Drug: Non arotinolol group<br>* Antihypertensive medications without arotinolol for 18 months<br>* Other names: Control group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite endpoints |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes for metabolism related index |  | 18 months | 
| Blood pressure control in hypertensive haemodialysis patients |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic kidney disease, hypertension