Hypertension, Resistant to Conventional TherapyRHNCT01833429
Autonomic Dysfunction in Resistant Hypertension
An observational study of Hypertension, Resistant to Conventional Therapy, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
The contribution of this study is the unedited evaluation of the circadian autonomic profiles of resistant hypertension with and without white-coat response. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Hypertension, Resistant to Conventional Therapy
- How many people
- 44 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2011to Dec 2012
- How long will I take part?
- 10 Months
- Phase
- Observational
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Forty-four resistant hypertension subjects, regularly followed up at the cardiovascular clinical pharmacology out-patients' clinic, and who complied with pharmacological prescription for hypertension, were recruited to participate in this transversal and observational study.
Who may be able to join
- resistant hypertensive patients
Who cannot join
- White-coat hypertension
- obstructive sleep apnea
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Cardiovascular Pharmacology Laboratory
Campinas, São Paulo, 13083-888
About this study
Official title: Circadian Autonomic Disturbances in Resistant Hypertension With and Without White-coat Phenomenon
The contribution of this study is the unedited evaluation of the circadian autonomic profiles of resistant hypertension with and without white-coat response.
Read the detailed description
All patients were submitted to office blood pressure measurement, Ambulatory blood pressure monitoring and 24-hour Holter monitoring.
Baseline blood samples for the measurement of glycemia (mg/dL), total cholesterol (mg/dL), LDL cholesterol (mg/dL), triglycerides (mg/dL), creatinine (mg/dL), serum uric acid, serum sodium, serum potassium, plasma aldosterone concentration (PAC) and plasma renin activity (PRA) were collected at 08:00 after overnight fasting.
- Keywords
- Resistant hypertension, White-coat phenomenon, Heart rate variability, autonomic activity
- Medical subject headings
- Hypertension Resistant to Conventional Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Resistant Hypertension | The current definition of resistant hypertension (RH) includes both patients whose blood pressure (BP) is uncontrolled on three or more medications and those whose BP is controlled when using four or more antihypertensive medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of the autonomic function in resistant hypertensive patients
The autonomic nervous system can be assessed by the heart rate variability. Variations in heart rate variability are normally observed in association with diurnal rhythms and blood pressure changes. The heart rate variability parameters are different in many studies, although the consensus is that lower values of the indices of vagal as well as high indices of sympathetic functions are associated prospectively with death and disability.
In humans, the disturbances of the circadian rhythms of heart rate variability and blood pressure have been intensively studied, mainly due to the increased cardiovascular death reported during the morning hours
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2013 (estimated)
- Study startSep 2011
- Primary completionNov 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hypertension, Resistant to Conventional TherapyStudies 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
- Observational
- Observational model
- Cohort
- Enrolment
- 44 participants (actual)
- Target duration
- 10 Months
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valéria Nasser Figueiredo, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01833429
- Sponsor's protocol ID
- 907/2011
- Acronym
- RH
- Status last verified
- Feb 2012
- First submitted
- 5 Apr 2013
- Last updated
- 16 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Calhoun DA, Jones D, Textor S, Goff DC, Murphy TP, Toto RD, White A, Cushman WC, White W, Sica D, Ferdinand K, Giles TD, Falkner B, Carey RM; American Heart Association Professional Education Committee. Resistant hypertension: diagnosis, evaluation, and treatment: a scientific statement from the American Heart Association Professional Education Committee of the Council for High Blood Pressure Research. Circulation. 2008 Jun 24;117(25):e510-26. doi: 10.1161/CIRCULATIONAHA.108.189141.
PubMed 18574054Muxfeldt ES, Fiszman R, de Souza F, Viegas B, Oliveira FC, Salles GF. Appropriate time interval to repeat ambulatory blood pressure monitoring in patients with white-coat resistant hypertension. Hypertension. 2012 Feb;59(2):384-9. doi: 10.1161/HYPERTENSIONAHA.111.185405. Epub 2012 Jan 3.
PubMed 22215711
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circadian Autonomic Disturbances in Resistant Hypertension With and Without White-coat Phenomenon
- ClinicalTrials.gov ID
- NCT01833429
- Acronym / sponsor ID
- RH / 907/2011
- Keywords
- Resistant hypertension, White-coat phenomenon, Heart rate variability, autonomic activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 16 Apr 2013 (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.
The contribution of this study is the unedited evaluation of the circadian autonomic profiles of resistant hypertension with and without white-coat response.
Detailed description
All patients were submitted to office blood pressure measurement, Ambulatory blood pressure monitoring and 24-hour Holter monitoring.
Baseline blood samples for the measurement of glycemia (mg/dL), total cholesterol (mg/dL), LDL cholesterol (mg/dL), triglycerides (mg/dL), creatinine (mg/dL), serum uric acid, serum sodium, serum potassium, plasma aldosterone concentration (PAC) and plasma renin activity (PRA) were collected at 08:00 after overnight fasting.
Study design
- Observational model
- Cohort
- Target follow-up
- 10 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Resistant Hypertension | – | –The current definition of resistant hypertension (RH) includes both patients whose blood pressure (BP) is uncontrolled on three or more medications and those whose BP is controlled when using four or more antihypertensive medications |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Forty-four resistant hypertension subjects, regularly followed up at the cardiovascular clinical pharmacology out-patients' clinic, and who complied with pharmacological prescription for hypertension, were recruited to participate in this transversal and observational study.
Key inclusion criteria (1 listed)
- resistant hypertensive patients
Key exclusion criteria (2 listed)
- White-coat hypertension
- obstructive sleep apnea
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
evaluation of the autonomic function in resistant hypertensive patients
Time frame: 10 months
The autonomic nervous system can be assessed by the heart rate variability. Variations in heart rate variability are normally observed in association with diurnal rhythms and blood pressure changes. The heart rate variability parameters are different in many studies, although the consensus is that lower values of the indices of vagal as well as high indices of sympathetic functions are associated prospectively with death and disability. In humans, the disturbances of the circadian rhythms of heart rate variability and blood pressure have been intensively studied, mainly due to the increased cardiovascular death reported during the morning hours
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 16 Apr 2013.
- Results publication: PubMed 18574054Calhoun DA, Jones D, Textor S, Goff DC, Murphy TP, Toto RD, White A, Cushman WC, White W, Sica D, Ferdinand K, Giles TD, Falkner B, Carey RM; American Heart Association Professional Education Committee. Resistant hypertension: diagnosis, evaluation, and treatment: a scientific statement from the American Heart Association Professional Education Committee of the Council for High Blood Pressure Research. Circulation. 2008 Jun 24;117(25):e510-26. doi: 10.1161/CIRCULATIONAHA.108.189141.
- Results publication: PubMed 22215711Muxfeldt ES, Fiszman R, de Souza F, Viegas B, Oliveira FC, Salles GF. Appropriate time interval to repeat ambulatory blood pressure monitoring in patients with white-coat resistant hypertension. Hypertension. 2012 Feb;59(2):384-9. doi: 10.1161/HYPERTENSIONAHA.111.185405. Epub 2012 Jan 3.
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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?
An observational study of Hypertension, Resistant to Conventional Therapy, run by University of Campinas, Brazil 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 1 inclusion and 2 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 16 Apr 2013. 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?
evaluation of the autonomic function in resistant hypertensive patients (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01833429, which also lists 2 linked publications.
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 16 Apr 2013.