NCT00811811

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started May 2005

Typical duration for not_applicable hypertension

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

May 1, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 18, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 19, 2008

Completed
Last Updated

December 19, 2008

Status Verified

December 1, 2008

Enrollment Period

1.3 years

First QC Date

December 18, 2008

Last Update Submit

December 18, 2008

Conditions

Hypertension

Keywords

HypertensionBiofeedbackRelaxation training

Outcome Measures

Primary Outcomes (1)

  • Ambulatory daytime and 24-hour systolic blood pressure, diastolic blood pressure, and pulse pressure.

    Baseline and Post-treatment (following 6 treatment sessions scheduled over an 8-week interval)

Secondary Outcomes (1)

  • RR interval, vagal-heart rate modulation (high frequency power in RR interval variability [0.15-0.40 Hz/ms2]) and baroreflex sensitivity

    8 weeks

Study Arms (2)

1

EXPERIMENTAL

Behavioral neurocardiac training

Behavioral: Behavioral neurocardiac training

2

ACTIVE COMPARATOR

Autogenic relaxation training

Behavioral: Autogenic relaxation training

Interventions

Behavioral neurocardiac trainingBEHAVIORAL

6 training sessions scheduled over 8 weeks

1
Autogenic relaxation trainingBEHAVIORAL

6 training sessions scheduled over 8 weeks

2

Eligibility Criteria

Age35 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (1)

  • 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.

    PMID: 20194302DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

HypnosisMind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Robert P Nolan, Ph.D.

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 18, 2008

First Posted

December 19, 2008

Study Start

May 1, 2005

Primary Completion

August 1, 2006

Study Completion

December 1, 2007

Last Updated

December 19, 2008

Record last verified: 2008-12

Locations

CA(1)