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

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ClinicalTrials.gov Identifier: NCT03001271
Recruitment Status : Unknown
Verified December 2016 by Instituto de Cardiologia do Rio Grande do Sul.
Recruitment status was:  Active, not recruiting
First Posted : December 23, 2016
Last Update Posted : December 23, 2016
Sponsor:
Information provided by (Responsible Party):
Instituto de Cardiologia do Rio Grande do Sul

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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Angiotensin 1-7 Other: Placebo Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Acute Effect of Agiotensin-(1-7) on Bood Pressure and Heart Rate in Healthy and Hypertensive Subjects
Study Start Date : January 2014
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Healthy Subjects
Placebo and Angiotensin-(1-7) acute infusion
Drug: Angiotensin 1-7
Other Name: Angio-1-7

Other: Placebo
Experimental: Hypertensive Subjects
Placebo and Angiotensin-(1-7) acute infusion
Drug: Angiotensin 1-7
Other Name: Angio-1-7

Other: Placebo



Primary Outcome Measures :
  1. Absence of adverse effects after Ang-(1-7) acute administration [ Time Frame: Along 25 hours ]

Secondary Outcome Measures :
  1. 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)

  2. 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

  3. Heart Rate Changes after Ang-(1-7) administration [ Time Frame: Recording along 24 hours ]
  4. 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



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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Responsible Party: Instituto de Cardiologia do Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT03001271     History of Changes
Other Study ID Numbers: 4576/10
First Posted: December 23, 2016    Key Record Dates
Last Update Posted: December 23, 2016
Last Verified: December 2016
Keywords provided by Instituto de Cardiologia do Rio Grande do Sul:
Angiotensin-(1-7)
Renin-angiotensin System
Autonomic Nervous System
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Angiotensin I (1-7)
Antihypertensive Agents
Vasodilator Agents