Effect of Arotinolol Hydrochloride on Cardiovascular Events in Hypertensive Haemodialysis Patients

Phase 4

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Drug: Arotinolol Hydrochloride; Drug: Non arotinolol group

• Registration Number: NCT01351636
• Lead Sponsor: Sumitomo Pharma (Suzhou) Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-05-05
• Study First Submitted QC: 2011-05-10
• Study First Posted: 2011-05-11
• Status Verified: 2015-11
• Primary Completion: 2018-10-10
• Study Completion: 2018-10-10
• Last Update Submitted: 2019-04-15
• Last Update Posted: 2019-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arotinolol Hydrochloride	Arotinolol Hydrochloride	Antihypertensive medications plus arotinolol hydrochloride
Non arotinolol group	Non arotinolol group	Antihypertensive medications without arotinolol hydrochloride

Primary Outcome Measures

Name	Time	Method
Composite endpoints	18 months

Secondary Outcome Measures

Name	Time	Method
Blood pressure control in hypertensive haemodialysis patients	18 months
Changes for metabolism related index	18 months

Trial Locations

Locations (1)

Nan Chen; 🇨🇳 Shanghai, Shanghai, China