NCT01833429

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 16, 2013

Completed
Last Updated

April 16, 2013

Status Verified

February 1, 2012

Enrollment Period

1.2 years

First QC Date

April 5, 2013

Last Update Submit

April 12, 2013

Conditions

Keywords

Resistant hypertensionWhite-coat phenomenonHeart rate variabilityautonomic activity

Outcome Measures

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

    10 months

Study Arms (1)

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

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • resistant hypertensive patients

You may not qualify if:

  • White-coat hypertension
  • obstructive sleep apnea

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular Pharmacology Laboratory

Campinas, São Paulo, 13083-888, Brazil

Location

Related 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 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.

  • 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.

MeSH Terms

Conditions

Hypertension Resistant to Conventional Therapy

Study Design

Study Type
observational
Observational Model
COHORT
Target Duration
10 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

April 5, 2013

First Posted

April 16, 2013

Study Start

September 1, 2011

Primary Completion

November 1, 2012

Study Completion

December 1, 2012

Last Updated

April 16, 2013

Record last verified: 2012-02

Locations