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

Hypertension Clinical Trial

— Ang-(1-7)  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03001271
• Other study ID #: 4576/10
• Status: Active, not recruiting
• Phase: Phase 0
• First received: December 2, 2016
• Last updated: December 20, 2016
• Start date: January 2014
• Est. completion date: March 2017

Study information

• Verified date: December 2016
• Source: Instituto de Cardiologia do Rio Grande do Sul
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Instituto de Cardiologia do Rio Grande do Sul
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: March 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Angiotensin 1-7

Other:
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Cardiologia do Rio Grande do Sul

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence of adverse effects after Ang-(1-7) acute administration		Along 25 hours	Yes
Secondary	Blood Pressure Changes after Ang-(1-7) administration	absence of measure changes in blood pressure or heart rate (increase or decrease)	Recording along 24 hours	Yes
Secondary	Ang-(1-7) effects on Blood Pressure Variability	Response of autonomic nervous system, registered for 1 hours, after Ang-(1-7) acute administration	Along 1 hours after Ang-(1-7) acute administration	No
Secondary	Heart Rate Changes after Ang-(1-7) administration		Recording along 24 hours	Yes
Secondary	Ang-(1-7) effects on Heart Rate Variability	Response of autonomic nervous system, registered for 1 hours, after Ang-(1-7) acute administration	Along 1 hours after Ang-(1-7) acute administration	No