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Acute Effect of Agiotensin-(1-7) in Healthy and Hypertensive Subjects (Ang-(1-7))

Primary Purpose

Hypertension

Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Angiotensin 1-7
Placebo
Sponsored by
Instituto de Cardiologia do Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hypertension focused on measuring Angiotensin-(1-7), Renin-angiotensin System, Autonomic Nervous System

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Healthy Group Inclusion Criteria:

  • arterial pressure <140/90 mmHg
  • body mass index (BMI) between 18,5 and 29 Kg/m2

Hypertensive Group Inclusion Criteria:

  • anti-hypertensive drug treatment
  • ambulatory blood pressure monitoring (ABMP) >130/85 mmHg
  • body mass index between 18,5 and 29 Kg/m2

Healthy Group Exclusion Criteria:

  • drug treatment
  • recent surgeries
  • pregnancy
  • previous cardiovascular events
  • high performance athletes
  • dislipidemia
  • diabetes
  • renal injury
  • obesity (BMI above 30 kg/m2)
  • alcoholism
  • smoking.

Hypertensive Group Exclusion Criteria:

  • recent surgeries
  • pregnancy
  • beta-blockers drug treatment
  • previous cardiovascular events
  • high performance athletes
  • dislipidemia
  • diabetes
  • renal injury
  • obesity (BMI above 30 kg/m2)
  • alcoholism
  • smoking

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Healthy Subjects

    Hypertensive Subjects

    Arm Description

    Placebo and Angiotensin-(1-7) acute infusion

    Placebo and Angiotensin-(1-7) acute infusion

    Outcomes

    Primary Outcome Measures

    Absence of adverse effects after Ang-(1-7) acute administration

    Secondary Outcome Measures

    Blood Pressure Changes after Ang-(1-7) administration
    absence of measure changes in blood pressure or heart rate (increase or decrease)
    Ang-(1-7) effects on Blood Pressure Variability
    Response of autonomic nervous system, registered for 1 hours, after Ang-(1-7) acute administration
    Heart Rate Changes after Ang-(1-7) administration
    Ang-(1-7) effects on Heart Rate Variability
    Response of autonomic nervous system, registered for 1 hours, after Ang-(1-7) acute administration

    Full Information

    First Posted
    December 2, 2016
    Last Updated
    December 20, 2016
    Sponsor
    Instituto de Cardiologia do Rio Grande do Sul
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03001271
    Brief Title
    Acute Effect of Agiotensin-(1-7) in Healthy and Hypertensive Subjects
    Acronym
    Ang-(1-7)
    Official Title
    Acute Effect of Agiotensin-(1-7) on Bood Pressure and Heart Rate in Healthy and Hypertensive Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    February 2017 (Anticipated)
    Study Completion Date
    March 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Instituto de Cardiologia do Rio Grande do Sul

    4. Oversight

    5. Study Description

    Brief Summary
    In the modern concept of Renin-angiotensin System, Angiotensin-(1-7) plays a key role and demonstrates promising therapeutic potential due to it is generally opposite effects to Angiotensin II. The aim is to evaluate the effect of Ang-(1-7) acute administration on systolic and diastolic blood pressure (SBP and DBP) and heart rate (HR) in healthy and hypertensive subjects.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension
    Keywords
    Angiotensin-(1-7), Renin-angiotensin System, Autonomic Nervous System

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Early Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Non-Randomized
    Enrollment
    32 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Healthy Subjects
    Arm Type
    Experimental
    Arm Description
    Placebo and Angiotensin-(1-7) acute infusion
    Arm Title
    Hypertensive Subjects
    Arm Type
    Experimental
    Arm Description
    Placebo and Angiotensin-(1-7) acute infusion
    Intervention Type
    Drug
    Intervention Name(s)
    Angiotensin 1-7
    Other Intervention Name(s)
    Angio-1-7
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    Absence of adverse effects after Ang-(1-7) acute administration
    Time Frame
    Along 25 hours
    Secondary Outcome Measure Information:
    Title
    Blood Pressure Changes after Ang-(1-7) administration
    Description
    absence of measure changes in blood pressure or heart rate (increase or decrease)
    Time Frame
    Recording along 24 hours
    Title
    Ang-(1-7) effects on Blood Pressure Variability
    Description
    Response of autonomic nervous system, registered for 1 hours, after Ang-(1-7) acute administration
    Time Frame
    Along 1 hours after Ang-(1-7) acute administration
    Title
    Heart Rate Changes after Ang-(1-7) administration
    Time Frame
    Recording along 24 hours
    Title
    Ang-(1-7) effects on Heart Rate Variability
    Description
    Response of autonomic nervous system, registered for 1 hours, after Ang-(1-7) acute administration
    Time Frame
    Along 1 hours after Ang-(1-7) acute administration

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Healthy Group Inclusion Criteria: arterial pressure <140/90 mmHg body mass index (BMI) between 18,5 and 29 Kg/m2 Hypertensive Group Inclusion Criteria: anti-hypertensive drug treatment ambulatory blood pressure monitoring (ABMP) >130/85 mmHg body mass index between 18,5 and 29 Kg/m2 Healthy Group Exclusion Criteria: drug treatment recent surgeries pregnancy previous cardiovascular events high performance athletes dislipidemia diabetes renal injury obesity (BMI above 30 kg/m2) alcoholism smoking. Hypertensive Group Exclusion Criteria: recent surgeries pregnancy beta-blockers drug treatment previous cardiovascular events high performance athletes dislipidemia diabetes renal injury obesity (BMI above 30 kg/m2) alcoholism smoking

    12. IPD Sharing Statement

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    Acute Effect of Agiotensin-(1-7) in Healthy and Hypertensive Subjects

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