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

December 20, 2016 updated by: Instituto de Cardiologia do Rio Grande do Sul

Acute Effect of Agiotensin-(1-7) on Bood Pressure and Heart Rate in Healthy and Hypertensive Subjects

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Early Phase 1

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 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy Subjects
Placebo and Angiotensin-(1-7) acute infusion
Other: Placebo
Drug: Angiotensin 1-7
Other Names:
  • Angio-1-7
Experimental: Hypertensive Subjects
Placebo and Angiotensin-(1-7) acute infusion
Other: Placebo
Drug: Angiotensin 1-7
Other Names:
  • Angio-1-7

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Absence of adverse effects after Ang-(1-7) acute administration
Time Frame: Along 25 hours
Along 25 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Pressure Changes after Ang-(1-7) administration
Time Frame: Recording along 24 hours
absence of measure changes in blood pressure or heart rate (increase or decrease)
Recording along 24 hours
Ang-(1-7) effects on Blood Pressure Variability
Time Frame: Along 1 hours after Ang-(1-7) acute administration
Response of autonomic nervous system, registered for 1 hours, after Ang-(1-7) acute administration
Along 1 hours after Ang-(1-7) acute administration
Heart Rate Changes after Ang-(1-7) administration
Time Frame: Recording along 24 hours
Recording along 24 hours
Ang-(1-7) effects on Heart Rate Variability
Time Frame: Along 1 hours after Ang-(1-7) acute administration
Response of autonomic nervous system, registered for 1 hours, after Ang-(1-7) acute administration
Along 1 hours after Ang-(1-7) acute administration

Collaborators and Investigators

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

Sponsor

Instituto de Cardiologia do Rio Grande do Sul

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

January 1, 2014

Primary Completion (Anticipated)

February 1, 2017

Study Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

December 2, 2016

First Submitted That Met QC Criteria

December 20, 2016

First Posted (Estimate)

December 23, 2016

Study Record Updates

Last Update Posted (Estimate)

December 23, 2016

Last Update Submitted That Met QC Criteria

December 20, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4576/10

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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