Behavioral Neurocardiac Training and Hypertension - Full Text View

Sponsors and Collaborators:	University Health Network, Toronto Unilever R&D Colworth.
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00811811

Purpose

This randomized controlled trial will examine whether behavioral neurocardiac training with heart rate variability biofeedback (BNT) augments reduction in ambulatory daytime and 24-hour SBP, DBP and PP, in comparison to an active control intervention (AC, autogenic relaxation training), among subjects diagnosed with hypertension, and following adjustment for medications. In addition, the independent association between the BNT and AC interventions on vagal-heart rate modulation and baroreflex sensitivity will be evaluated during a standardized assessment protocol of mental stress testing. This study extends a previous trial conducted at the UHN, in which we reported that the biofeedback intervention independently augments vagal-heart rate modulation, while reducing symptoms of stress and depressed mood, among subjects diagnosed with cardiovascular disease. Exploratory features of this trial will examine the association between ambulatory blood pressure, vagal-heart rate modulation, baroreflex sensitivity, and markers of inflammatory activity.

Condition	Intervention
Hypertension	Behavioral: Behavioral neurocardiac training Behavioral: Autogenic relaxation training

MedlinePlus related topics: High Blood Pressure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Subject), Active Control, Parallel Assignment
Official Title:	Behavioral Neurocardiac Training With Biofeedback Augments Vagal-Heart Rate Modulation and Baroreflex Sensitivity Among Patients With Hypertension

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:

Ambulatory daytime and 24-hour systolic blood pressure, diastolic blood pressure, and pulse pressure. [ Time Frame: Baseline and Post-treatment (following 6 treatment sessions scheduled over an 8-week interval) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

RR interval, vagal-heart rate modulation (high frequency power in RR interval variability [0.15-0.40 Hz/ms2]) and baroreflex sensitivity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment:	65
Study Start Date:	May 2005
Study Completion Date:	December 2007
Primary Completion Date:	August 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Behavioral neurocardiac training	Behavioral: Behavioral neurocardiac training 6 training sessions scheduled over 8 weeks
2: Active Comparator Autogenic relaxation training	Behavioral: Autogenic relaxation training 6 training sessions scheduled over 8 weeks

Eligibility

Ages Eligible for Study:	35 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

35 to 64 years of age
diagnosis of Grade 1 or 2 hypertension (140-159 mmHg or 160-180 mmHg SBP; or 90-99 or 100-110 mmHg DBP, respectively).
among subjects not prescribed medication, hypertension confirmed by ambulatory BP monitoring: mean 24-hour SBP > 130 mmHg or DBP > 80 mmHg.
subjects prescribed antihypertensive pharmacotherapy are required to have a treatment regimen that was unchanged for at least 4 months prior to enrollment.

Exclusion criteria:

diagnosis of cardiovascular disease, clinically significant arrhythmia, sleep disorder, psychiatric illness (eg. psychosis), alcohol/drug dependence within the previous year, or an inability to comprehend English or French

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00811811

Locations

Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4

Sponsors and Collaborators

University Health Network, Toronto

Unilever R&D Colworth.

Investigators

Principal Investigator:

Robert P Nolan, Ph.D.

University Health Network, Toronto

More Information

Responsible Party:	University Health Network ( Robert P. Nolan/Director Behavioural Cardiology Research Unit )
Study ID Numbers:	04-516-BE
Study First Received:	December 18, 2008
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00811811
Health Authority:	Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:

Hypertension
Biofeedback
Relaxation training

Study placed in the following topic categories:

Vascular Diseases
Hypertension

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 10, 2009