The Effects of Doxazosin and Nifedipine on Blood Pressure Variability and Uric Acid in Plasma in Hypertensive Patients

July 26, 2016 updated by: First Affiliated Hospital of Harbin Medical University

Hypertension is one of the most common cardiovascular diseases, which is a major risk factor for stroke and cardiovascular events. Accumulated data has shown that target-organ damage is related not only to 24-h mean intra-arterial BP, but also to BP variability (BPV) in subjects with essential hypertension. There are many studies about the effects of different kinds of drugs on blood pressure, but the clinical researches about the impacts of antihypertensive drugs on BPV are limited, and the conclusion is still controversial.

In addition, recent studies found that the occurrence and development of hypertension, especially essential hypertension, are closely related with hyperuricemia. Serum UA is an independently prognostic indicator for the development of hypertension. Some studies have observed the effects of different kinds of antihypertensive drugs on uric acid level in hypertensive patients. After adjustment, calcium channel blockers are associated with a lower risk of incident gout among people with hypertension. However, the effects of alpha blockers on uric acid in plasma are still not very clear.

Therefore, we performed this study to observe the different effects of alpha blocker and calcium channel blocker on blood pressure variability and uric acid level in hypertensive patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Hypertension is one of the most common cardiovascular diseases, which is a major risk factor for stroke and cardiovascular events. Traditionally, cardiovascular risk stratification in hypertensive patients was based on the average blood pressure (BP) measured in the clinic. Accumulated data has shown that target-organ damage is related not only to 24-h mean intra-arterial BP, but also to BP variability (BPV) in subjects with essential hypertension. Growing evidence demonstrated that BPV has considerable prognostic value for all-cause mortality and cardiovascular outcomes, independent of average BP. At present, the normal range of BPV is not very clear. There are many studies about the effects of different kinds of drugs on blood pressure, but the clinical researches about the impacts of antihypertensive drugs on BPV are limited, and the conclusion is still controversial.

In addition, recent studies found that the occurrence and development of hypertension, especially essential hypertension, are closely related with hyperuricemia. Accumulated data has shown that a significant and independent association between the uric acid level and the onset of hypertension in both men and women participants. Serum UA is an independently prognostic indicator for the development of hypertension. Some studies have observed the effects of different kinds of antihypertensive drugs on uric acid level in hypertensive patients. After adjustment, diuretics, β blockers, angiotensin converting enzyme inhibitors and non-losartan angiotensin Ⅱ receptor antagonists are associated with an increased risk of gout. In contrast, calcium channel blockers and losartan are associated with a lower risk of incident gout among people with hypertension. However, the effects of alpha blockers on uric acid in plasma are still not very clear.

Therefore, we performed this study to observe the different effects of alpha blocker and calcium channel blocker on blood pressure variability and uric acid level in hypertensive patients.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

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

Study Locations

  • China
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150001
        • Recruiting
        • uric acid test and 24-hour ambulatory BP monitoring
        • 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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Men aged between 18 and 75 included years old Postmenopausal women who are no more than 75 years older. Patients with essential mild to moderate uncomplicated hypertension (DBP<110mmHg and SBP<180mmHg measured with a validated automatic device in sitting position) after initiation or intensification of appropriate healthy lifestyle modification, Without antihypertensive treatment in 2 weeks.

Exclusion Criteria:

History of cerebrovascular disease: ischemic stroke, cerebral haemorrhage and TIA.

History of cardiovascular disease:unstable angina, myocardial infarction, coronary revascularization and congestive heart failure.

History of renal impairment. History of Type I diabetes mellitus or Type II diabetes uncontrolled. History of liver impairment. History of alcoholism or drug abuse. Known symptomatic orthostatic hypotension. Contra-indications to treatment with investigate products.

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: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: doxazosin
To observe the effects of doxazosin (4 mg) on uric acid in plasma and blood pressure variability after 12 weeks of treatment
Drug: Nifedipine
Nifedipine was given orally in a dose of 30 mg/day to treat patients in the amlodipine group for 12 weeks.
Drug: Doxazosin
Doxazosin was given orally in a dose of 4 mg/day to treat patients in the doxazosin group for 12 weeks.
Active Comparator: nifedipine
To observe the effects of nifedipine (30 mg) on uric acid in plasma and blood pressure variability after 12 weeks of treatment
Drug: Nifedipine
Nifedipine was given orally in a dose of 30 mg/day to treat patients in the amlodipine group for 12 weeks.
Drug: Doxazosin
Doxazosin was given orally in a dose of 4 mg/day to treat patients in the doxazosin group for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
24-hour Ambulatory Blood Pressure Monitoring
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
plasma uric acid level
Time Frame: 3 years
3 years

Collaborators and Investigators

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

Sponsor

First Affiliated Hospital of Harbin Medical University

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

September 1, 2015

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

October 1, 2018

Study Registration Dates

First Submitted

September 28, 2015

First Submitted That Met QC Criteria

September 28, 2015

First Posted (Estimate)

September 30, 2015

Study Record Updates

Last Update Posted (Estimate)

July 28, 2016

Last Update Submitted That Met QC Criteria

July 26, 2016

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HT-3-UA

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.

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