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Completed

NCT Number: NCT00811811

Behavioral Neurocardiac Training and Hypertension

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

35 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavioral neurocardiac training

Behavioral

6 training sessions scheduled over 8 weeks

Autogenic relaxation training

Behavioral

6 training sessions scheduled over 8 weeks

Primary outcomes

  1. 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)

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

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Unilever R&D

Registry information

Official study title

Behavioral Neurocardiac Training With Biofeedback Augments Vagal-Heart Rate Modulation and Baroreflex Sensitivity Among Patients With Hypertension

Important dates

Study start
2005
Primary completion
2006
Study completion
2007
First posted
Dec 19, 2008
Registry last updated
Dec 19, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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