HypertensionNCT02211248
Cardiovascular Autonomic Control Evaluation Through Cardiac Frequency Variability in Hypertensive Patients
A study testing Multidisciplinary assistance and Conventional treatment and follow up in people with Hypertension, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
Trial summary
Analyzing cardiovascular evaluation measures in the multidisciplinary and in the conventional treatment of hypertensive patients will provide better parameters for comparing the two approaches. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Multidisciplinary assistance and Conventional treatment and follow up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2011to Jul 2013
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Above 18 years of age
- Diagnosis of primary hypertension
Who cannot join
- Neurological condition
- Cardiac condition
- Renal condition
- Congenital conditions
- Previous myocardial revascularization surgery
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Cardiologia do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90620-000
About this study
Official title: Cardiovascular Autonomic Control Evaluation Through Cardiac Frequency Variability in Hypertensive Patients Subjected to Distinct Interventions: Clinical Trial
Analyzing cardiovascular evaluation measures in the multidisciplinary and in the conventional treatment of hypertensive patients will provide better parameters for comparing the two approaches.
- Conditions
- Hypertension
- Being tested
- Multidisciplinary assistance, Conventional treatment and follow up
- Keywords
- Cardiac Frequency Variability, multidisciplinary care, clinical trial
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary assistanceOther
Multidisciplinary group assistance was effected every two months by all professionals (physician, nurse, dietitian, physiotherapist and psychologist) and consisted in orientations and mechanisms to medication and non-pharmacological adherence (lifestyle changes).
Conventional treatment and follow upOther
Assistance was effected by physician and nurse and consisted about adapting to the drug
| Study group | Role | What they receive |
|---|---|---|
| Conventional Group | Active comparator | Conventional treatment and follow up Receives: Other: Conventional treatment and follow up |
| Multidisciplinary Group | Experimental | Multidisciplinary assistance Receives: Other: Multidisciplinary assistance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Cardiac Frequency Variability at 1 year
Measured: Measured at the first appointment and 1 year later
Secondary outcomes (1)
Change from Baseline in Systolic and Diastolic Blood pressure
Measured: Measured at the first appointment and 1 year later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study startDec 2011
- Primary completionJul 2013
- Study completionJul 2013
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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvia Goldmeier, Instituto de Cardiologia do Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02211248
- Sponsor's protocol ID
- 4524/10
- Status last verified
- Aug 2014
- First submitted
- 31 Jul 2014
- Last updated
- 7 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Autonomic Control Evaluation Through Cardiac Frequency Variability in Hypertensive Patients Subjected to Distinct Interventions: Clinical Trial
- ClinicalTrials.gov ID
- NCT02211248
- Acronym / sponsor ID
- 4524/10
- Conditions
- Hypertension
- Keywords
- Cardiac Frequency Variability, multidisciplinary care, clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do SulUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 7 Aug 2014 (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.
Analyzing cardiovascular evaluation measures in the multidisciplinary and in the conventional treatment of hypertensive patients will provide better parameters for comparing the two approaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Group | Active comparator | Other: Conventional treatment and follow upConventional treatment and follow up |
| Multidisciplinary Group | Experimental | Other: Multidisciplinary assistanceMultidisciplinary assistance |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Above 18 years of age
- Diagnosis of primary hypertension
Key exclusion criteria (5 listed)
- Neurological condition
- Cardiac condition
- Renal condition
- Congenital conditions
- Previous myocardial revascularization surgery
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 |
|---|---|---|
| Multidisciplinary assistanceMultidisciplinary group assistance was effected every two months by all professionals (physician, nurse, dietitian, physiotherapist and psychologist) and consisted in orientations and mechanisms to medication and non-pharmacological adherence (lifestyle changes). | Other | Multidisciplinary Group |
| Conventional treatment and follow upAssistance was effected by physician and nurse and consisted about adapting to the drug | Other | Conventional Group |
Primary outcome
Change from Baseline in Cardiac Frequency Variability at 1 year
Time frame: Measured at the first appointment and 1 year later
1 secondary outcome
Change from Baseline in Systolic and Diastolic Blood pressure
Time frame: Measured at the first appointment and 1 year later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidisciplinary assistance and Conventional treatment and follow up in people with Hypertension, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. 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: finished, as of the sponsor's last update on 7 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from Baseline in Cardiac Frequency Variability at 1 year (time frame: Measured at the first appointment and 1 year later). 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 7 Aug 2014.