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

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ClinicalTrials.gov Identifier: NCT02563405
Recruitment Status : Unknown
Verified September 2015 by First Affiliated Hospital of Harbin Medical University.
Recruitment status was:  Recruiting
First Posted : September 30, 2015
Last Update Posted : July 28, 2016
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital of Harbin Medical University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Hypertension Drug: Doxazosin Drug: Nifedipine Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Doxazosin and Nifedipine on Blood Pressure Variability and Uric Acid in Plasma in Hypertensive Patients
Study Start Date : September 2015
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


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: Doxazosin
Doxazosin was given orally in a dose of 4 mg/day to treat patients in the doxazosin group for 12 weeks.

Drug: Nifedipine
Nifedipine was given orally in a dose of 30 mg/day to treat patients in the amlodipine 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: Doxazosin
Doxazosin was given orally in a dose of 4 mg/day to treat patients in the doxazosin group for 12 weeks.

Drug: Nifedipine
Nifedipine was given orally in a dose of 30 mg/day to treat patients in the amlodipine group for 12 weeks.




Primary Outcome Measures :
  1. 24-hour Ambulatory Blood Pressure Monitoring [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. plasma uric acid level [ Time Frame: 3 years ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02563405


Contacts
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Contact: Yue Li, PHD 86-451-85555673 ly99ly@vip.163.com
Contact: Jing Shi, MM 86-451-85555672 yidashijing@163.com

Locations
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China, Heilongjiang
uric acid test and 24-hour ambulatory BP monitoring Recruiting
Harbin, Heilongjiang, China, 150001
Contact: Yujiao Pan, MM    86-451-85555671    panyujiao@163.com   
Sponsors and Collaborators
First Affiliated Hospital of Harbin Medical University

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Responsible Party: First Affiliated Hospital of Harbin Medical University
ClinicalTrials.gov Identifier: NCT02563405     History of Changes
Other Study ID Numbers: HT-3-UA
First Posted: September 30, 2015    Key Record Dates
Last Update Posted: July 28, 2016
Last Verified: September 2015
Keywords provided by First Affiliated Hospital of Harbin Medical University:
alpha receptor blocker
uric acid
CCB
blood pressure variability
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Doxazosin
Nifedipine
Uric Acid
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents
Antioxidants
Protective Agents
Antihypertensive Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents