HypertensionEarly Phase 1Ang-(1-7)NCT03001271
Acute Effect of Agiotensin-(1-7) in Healthy and Hypertensive Subjects
A Early Phase 1 study testing Angiotensin 1-7 in people with Hypertension, run by Instituto de Cardiologia do Rio Grande do Sul.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Angiotensin 1-7
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Mar 2017
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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
About this study
Official title: 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.
- Conditions
- Hypertension
- Being tested
- Angiotensin 1-7, Placebo
- Keywords
- Angiotensin-(1-7), Renin-angiotensin System, Autonomic Nervous System
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiotensin 1-7Drug
Also called Angio-1-7
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Healthy Subjects | Experimental | Placebo and Angiotensin-(1-7) acute infusion Receives: Drug: Angiotensin 1-7; Other: Placebo |
| Hypertensive Subjects | Experimental | Placebo and Angiotensin-(1-7) acute infusion Receives: Drug: Angiotensin 1-7; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of adverse effects after Ang-(1-7) acute administration
Measured: Along 25 hours
Secondary outcomes (4)
Blood Pressure Changes after Ang-(1-7) administration
absence of measure changes in blood pressure or heart rate (increase or decrease)
Measured: Recording along 24 hours
Ang-(1-7) effects on Blood Pressure Variability
Response of autonomic nervous system, registered for 1 hours, after Ang-(1-7) acute administration
Measured: Along 1 hours after Ang-(1-7) acute administration
Heart Rate Changes after Ang-(1-7) administration
Measured: Recording along 24 hours
Ang-(1-7) effects on Heart Rate Variability
Response of autonomic nervous system, registered for 1 hours, after Ang-(1-7) acute administration
Measured: Along 1 hours after Ang-(1-7) acute administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2016 (estimated)
- Study startJan 2014
- Primary completionFeb 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03001271
- Sponsor's protocol ID
- 4576/10
- Acronym
- Ang-(1-7)
- Status last verified
- Dec 2016
- First submitted
- 2 Dec 2016
- Last updated
- 23 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Agiotensin-(1-7) on Bood Pressure and Heart Rate in Healthy and Hypertensive Subjects
- ClinicalTrials.gov ID
- NCT03001271
- Acronym / sponsor ID
- Ang-(1-7) / 4576/10
- Conditions
- Hypertension
- Keywords
- Angiotensin-(1-7), Renin-angiotensin System, Autonomic Nervous System
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do SulUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 23 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects | Experimental | Drug: Angiotensin 1-7, Other: PlaceboPlacebo and Angiotensin-(1-7) acute infusion |
| Hypertensive Subjects | Experimental | Drug: Angiotensin 1-7, Other: PlaceboPlacebo and Angiotensin-(1-7) acute infusion |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Angiotensin 1-7Also: Angio-1-7 | Drug | Healthy Subjects, Hypertensive Subjects |
| Placebo | Other | Healthy Subjects, Hypertensive Subjects |
Primary outcome
Absence of adverse effects after Ang-(1-7) acute administration
Time frame: Along 25 hours
4 secondary outcomes
Blood Pressure Changes after Ang-(1-7) administration
Time frame: Recording along 24 hours
Ang-(1-7) effects on Blood Pressure Variability
Time frame: Along 1 hours after Ang-(1-7) acute administration
Heart Rate Changes after Ang-(1-7) administration
Time frame: Recording along 24 hours
Ang-(1-7) effects on Heart Rate Variability
Time frame: Along 1 hours after Ang-(1-7) acute administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Angiotensin 1-7 in people with Hypertension, run by Instituto de Cardiologia do Rio Grande do Sul.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absence of adverse effects after Ang-(1-7) acute administration (time frame: Along 25 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2016.