<?xml version="1.0" encoding="UTF-8"?>

<trials>

    <trial>
        <main>
            <trial_id>RBR-8mx5g6</trial_id>
            <utrn>U1111-1121-5553</utrn>
            <reg_name>REBEC</reg_name>
            <date_registration>03/07/2011</date_registration>
            <primary_sponsor>Escola de Educação Física e Esporte da Universidade de São Paulo - Brazil</primary_sponsor>
            <public_title>Influence of captopril use on blood pressure response measured after a single bout of strength exercise in men with high blood pressure</public_title>
            <acronym></acronym>
            <scientific_title>Effect of captopril use on blood pressure response after a single bout of resistance exercise in hypertensive men</scientific_title>
            <scientific_acronym></scientific_acronym>
            <date_enrolment>01/07/2011</date_enrolment>
            <type_enrolment>actual</type_enrolment>
            <target_size>24</target_size>
            <recruitment_status>not yet recruiting</recruitment_status>
            <url>http://www.ensaiosclinicos.gov.br/rg/RBR-8mx5g6/</url>
            <study_type></study_type>
            <study_design>Randomized controlled clinical trial, with 2 arms, phase 4,  double-blinded.</study_design>
            <phase>4</phase>
            <hc_freetext>Hypertension</hc_freetext>
            <i_freetext>Groups: normotensives and hypertensives
Normotensives: Evaluated without any teraphy
Hypertensives: different oral therapies, administered for 4 weeks each (random and double blinded). Therapies = captopril (50-75mg, 3 times a day) and placebo (3cp/day).
</i_freetext>            
        </main>
        <contacts>
        
            <contact>
                <type>public</type>
                <firstname>Claudia</firstname>
                <middlename>Lucia de Moraes</middlename>
                <lastname>Forjaz</lastname>
                <address>Av. Prof. Mello Moraes, 65 - Butantã</address>
                <city>São Paulo</city>
                <country1>Brazil</country1>
                <zip>05508030</zip>
                <telephone>551130913136</telephone>
                <email>cforjaz@usp.br</email>
                <affiliation>Escola de Educação Física e Esporte da Universidade de São Paulo</affiliation>
            </contact>
        
        
            <contact>
                <type>scientific</type>
                <firstname>Claudia</firstname>
                <middlename>Lucia de Moraes</middlename>
                <lastname>Forjaz</lastname>
                <address>Av. Prof. Mello Moraes, 65 - Butantã</address>
                <city>São Paulo</city>
                <country1>Brazil</country1>
                <zip>05508030</zip>
                <telephone>551130913136</telephone>
                <email>cforjaz@usp.br</email>
                <affiliation>Escola de Educação Física e Esporte da Universidade de São Paulo</affiliation>
            </contact>
        
        </contacts>
        <countries>
        
            <country2>Brazil</country2>
        
        </countries>
        <criteria>
            <inclusion_criteria>Men
Aged between 30 and 60 years
Non smokers
Physically inactives (did not perform physical activity more than twice a week)
Normotensives and hypertensives will form different groups
Hypertensives should not have end organ damage or secondary causes of hypertension according to the diagnotic rotine of the Hypertension League of Clinical Hospital, Faculty of Medicine, USP.  </inclusion_criteria>
            <agemin>30Y</agemin>
            <agemax>60Y</agemax>
            <gender>M</gender>
            <exclusion_criteria>Subjects with obesity (body mass index equal or greater than 30 kg/m2)
Subjects with diabetes (fasting glycemia equal or greater than 126 mg/dl)
Subjects with cardiac diseases (previous diagnosis or alteration on resting or exercise ECG)
Subjects who do not tolerate the study medication</exclusion_criteria>
        </criteria>
        <health_condition_code>
            
            <hc_code>C14</hc_code>
            
        </health_condition_code>
        <health_condition_keyword>
            
            <hc_keyword>C14.907.489</hc_keyword>
            
        </health_condition_keyword>
        <intervention_code>
            
            <i_code>drug</i_code>
            
            <i_code>other</i_code>
            
        </intervention_code>
        <intervention_keyword>
            
            <i_keyword>F01.145.632</i_keyword>
            
            <i_keyword>D27.505.519.389.745.085</i_keyword>
            
        </intervention_keyword>
        <primary_outcome>
            
            <prim_outcome>post-exercise hypotension - evaluated by the measurement of clinic (auscultatory) and ambulatorial (oscillometric) blood pressure before and after rest and resistance exercise while receiving placebo and captopril.</prim_outcome>
            
        </primary_outcome>
        <secondary_outcome>
            
            <sec_outcome>hemodynamics - evaluated by the measurement of cardiac output (CO2 rebreathing)and heart hate (ECG) performed before and after rest and resistance exercise while receiving placebo and captopril. Systemic vascular resistance and stroke volume will be calculated.</sec_outcome>
            
            <sec_outcome>Autonomic modulation - evaluated by the measurement of heart rate and blood pressure variabilities (spectral analysis) performed before and after rest and resistance exercise while receiving placebo and captopril</sec_outcome>
            
            <sec_outcome>Vascular function - evaluated by the measurement of baseline blood flow and its response to the reactive hyperemia maneuver (venous occlusion pletismography) performed before and after rest and resistance exercise while receiving placebo and captopril.</sec_outcome>
            
        </secondary_outcome>
        <secondary_sponsor>
            
            <sponsor_name>Laboratório de Hipertensão do Hospital das Clínicas da Faculdade de Medicina da USP - Brazil</sponsor_name>
            
        </secondary_sponsor>
        <secondary_ids>
            
            <secondary_id>
                <sec_id>CAAE-0005.0.342.000-10</sec_id>
                <issuing_authority>CONEP</issuing_authority>    
            </secondary_id>
            
            <secondary_id>
                <sec_id>2010/05</sec_id>
                <issuing_authority>CEP39</issuing_authority>    
            </secondary_id>
            
        </secondary_ids>
        <source_support>
            
            <source_name>Pro Reitoria de Graduação da Universidade de São Paulo - Brazil</source_name>
            
            <source_name>Fundação de Amparo à Pesquisa do Estado de São Paulo - Brazil</source_name>
            
        </source_support>        
    </trial>

</trials>


