Clinical trial NCT00811811: Behavioral Neurocardiac Training and Hypertension
Official title: Behavioral Neurocardiac Training With Biofeedback Augments Vagal-Heart Rate Modulation and Baroreflex Sensitivity Among Patients With Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Biofeedback
Relaxation training
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Unilever R&D
First posted: 2008-12-19
Enrollment: 65
Sex: ALL
Minimum age (years): 35
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Ambulatory daytime and 24-hour systolic blood pressure, diastolic blood pressure, and pulse pressure.
timeFrame: Baseline and Post-treatment (following 6 treatment sessions scheduled over an 8-week interval)
Secondary outcomes:
measure: RR interval, vagal-heart rate modulation (high frequency power in RR interval variability [0.15-0.40 Hz/ms2]) and baroreflex sensitivity
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Robert P Nolan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nolan RP, Floras JS, Harvey PJ, Kamath MV, Picton PE, Chessex C, Hiscock N, Powell J, Catt M, Hendrickx H, Talbot D, Chen MH. Behavioral neurocardiac training in hypertension: a randomized, controlled trial. Hypertension. 2010 Apr;55(4):1033-9. doi: 10.1161/HYPERTENSIONAHA.109.146233. Epub 2010 Mar 1.