NCT03001271

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P50-P75 for early_phase_1 hypertension

Timeline
Completed

Started Jan 2014

Typical duration for early_phase_1 hypertension

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

December 2, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 23, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

December 23, 2016

Status Verified

December 1, 2016

Enrollment Period

3.1 years

First QC Date

December 2, 2016

Last Update Submit

December 20, 2016

Conditions

Keywords

Angiotensin-(1-7)Renin-angiotensin SystemAutonomic Nervous System

Outcome Measures

Primary Outcomes (1)

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

    Along 25 hours

Secondary Outcomes (4)

  • Blood Pressure Changes after Ang-(1-7) administration

    Recording along 24 hours

  • Ang-(1-7) effects on Blood Pressure Variability

    Along 1 hours after Ang-(1-7) acute administration

  • Heart Rate Changes after Ang-(1-7) administration

    Recording along 24 hours

  • Ang-(1-7) effects on Heart Rate Variability

    Along 1 hours after Ang-(1-7) acute administration

Study Arms (2)

Healthy Subjects

EXPERIMENTAL

Placebo and Angiotensin-(1-7) acute infusion

Drug: Angiotensin 1-7Other: Placebo

Hypertensive Subjects

EXPERIMENTAL

Placebo and Angiotensin-(1-7) acute infusion

Drug: Angiotensin 1-7Other: Placebo

Interventions

Also known as: Angio-1-7
Healthy SubjectsHypertensive Subjects
PlaceboOTHER
Healthy SubjectsHypertensive Subjects

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • arterial pressure \<140/90 mmHg
  • body mass index (BMI) between 18,5 and 29 Kg/m2
  • anti-hypertensive drug treatment
  • ambulatory blood pressure monitoring (ABMP) \>130/85 mmHg
  • body mass index between 18,5 and 29 Kg/m2

You may not qualify if:

  • drug treatment
  • recent surgeries
  • pregnancy
  • previous cardiovascular events
  • high performance athletes
  • dislipidemia
  • diabetes
  • renal injury
  • obesity (BMI above 30 kg/m2)
  • alcoholism
  • smoking.
  • recent surgeries
  • pregnancy
  • beta-blockers drug treatment
  • previous cardiovascular events
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Interventions

angiotensin I (1-7)

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2016

First Posted

December 23, 2016

Study Start

January 1, 2014

Primary Completion

February 1, 2017

Study Completion

March 1, 2017

Last Updated

December 23, 2016

Record last verified: 2016-12