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CompletedNCT01833429RHUpdated Apr 16, 2013

Autonomic Dysfunction in Resistant Hypertension

An observational study in Hypertension, Resistant to Conventional Therapy, sponsored by University of Campinas, Brazil. Completed at 1 site in Brazil. Open to participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2013-04-16.

Sponsored by University of Campinas, Brazil · Observational

Study type
Observational
Model
Cohort
Enrollment
44
Ages
30 Years to 60 Years
Sex
All
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Study 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 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.

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Conditions studied

  • Hypertension, Resistant to Conventional Therapy

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Keywords

  • Resistant hypertension
  • White-coat phenomenon
  • Heart rate variability
  • autonomic activity
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In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 964 are open to participants now.

This study's enrollment of 44 is below the median of 210 across 1,358 observational studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

University of Campinas, Brazil is the lead sponsor of 166 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

Inclusion criteria

  • resistant hypertensive patients

Exclusion criteria

Exclusion Criteria:

  • White-coat hypertension
  • obstructive sleep apnea
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Study design

Observational model
Cohort
Enrollment
44 participants (actual)
Target follow-up
10 Months
Patient registry
Yes

Groups and cohorts

  • 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

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 10 months

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Study locations

1 site
  • Cardiovascular Pharmacology Laboratory
    Campinas, Sao Paulo 13083-888, Brazil
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References and documents

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 18574054 ↗
  • Muxfeldt 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01833429
Lead sponsor
University of Campinas, Brazil
Responsible party
Valéria Nasser Figueiredo (PhD, University of Campinas, Brazil) — Principal investigator
First posted
Apr 16, 2013
Start date
Sep 2011
Primary completion
Nov 2012
Completion
Dec 2012
Last update
Apr 16, 2013

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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