Autonomic Dysfunction in Resistant Hypertension (RH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01833429
Recruitment Status : Completed
First Posted : April 16, 2013
Last Update Posted : April 16, 2013
Information provided by (Responsible Party):
Valéria Nasser Figueiredo, University of Campinas, Brazil

Brief Summary:
The contribution of this study is the unedited evaluation of the circadian autonomic profiles of resistant hypertension with and without white-coat response.

Condition or disease
Hypertension, Resistant to Conventional Therapy

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 Type : Observational [Patient Registry]
Actual Enrollment : 44 participants
Observational Model: Cohort
Target Follow-Up Duration: 10 Months
Official Title: Circadian Autonomic Disturbances in Resistant Hypertension With and Without White-coat Phenomenon
Study Start Date : September 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : December 2012

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

Primary Outcome Measures :
  1. 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

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   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:

  • White-coat hypertension
  • obstructive sleep apnea

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01833429

Cardiovascular Pharmacology Laboratory
Campinas, Sao Paulo, Brazil, 13083-888
Sponsors and Collaborators
University of Campinas, Brazil

Publications of Results:
Responsible Party: Valéria Nasser Figueiredo, PhD, University of Campinas, Brazil Identifier: NCT01833429     History of Changes
Other Study ID Numbers: 907/2011
First Posted: April 16, 2013    Key Record Dates
Last Update Posted: April 16, 2013
Last Verified: February 2012

Keywords provided by Valéria Nasser Figueiredo, University of Campinas, Brazil:
Resistant hypertension
White-coat phenomenon
Heart rate variability
autonomic activity

Additional relevant MeSH terms:
Coronary Vasospasm
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Myocardial Ischemia
Heart Diseases