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

Early Phase 1

• Conditions: Hypertension
• Interventions: Drug: Angiotensin 1-7; Other: Placebo

• Registration Number: NCT03001271
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Status Verified: 2016-12
• Study First Submitted: 2016-12-02
• Study First Submitted QC: 2016-12-20
• Last Update Submitted: 2016-12-20
• Study First Posted: 2016-12-23
• Last Update Posted: 2016-12-23
• Primary Completion: 2017-02
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hypertensive Subjects	Placebo	Placebo and Angiotensin-(1-7) acute infusion
Healthy Subjects	Angiotensin 1-7	Placebo and Angiotensin-(1-7) acute infusion
Healthy Subjects	Placebo	Placebo and Angiotensin-(1-7) acute infusion
Hypertensive Subjects	Angiotensin 1-7	Placebo and Angiotensin-(1-7) acute infusion

Primary Outcome Measures

Name	Time	Method
Absence of adverse effects after Ang-(1-7) acute administration	Along 25 hours

Secondary Outcome Measures

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