Autonomic Dysfunction in Resistant Hypertension

Hypertension, Resistant to Conventional Therapy Clinical Trial

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Official title:

Circadian Autonomic Disturbances in Resistant Hypertension With and Without White-coat Phenomenon

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01833429
• Other study ID #: 907/2011
• Status: Completed
• Phase: N/A
• First received: April 5, 2013
• Last updated: April 12, 2013
• Start date: September 2011
• Est. completion date: December 2012

Study information

• Verified date: February 2012
• Source: University of Campinas, Brazil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 60 Years

Eligibility

Inclusion Criteria:

• resistant hypertensive patients

Exclusion Criteria:

• White-coat hypertension

• obstructive sleep apnea

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Coronary Vasospasm
• Hypertension
• Hypertension, Resistant to Conventional Therapy

Locations

Country	Name	City	State
Brazil	Cardiovascular Pharmacology Laboratory	Campinas	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

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 t — View Citation

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/HYPERTENSIO — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	10 months	No