Clinical trial NCT02916550: Breathing Intervention for Cardiac Anxiety
Official title: Anatomical and Psychophysiological Substrates of Interoception
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atrial Fibrillation
Implantable Cardioverter Defibrillator
Lead sponsor: Laureate Institute for Brain Research, Inc.
Sponsor class: OTHER
Collaborators: name: University of Arizona
First posted: 2016-09-27
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study examines the impact of a breathing training intervention on cardiorespiratory sensations and anxiety in adults with cardiac arrhythmias.

Detailed description: Patients with cardiac arrhythmias develop increased rates of anxiety and depression. Atrial arrhythmias, such as paroxysmal atrial fibrillation (AF), and ventricular arrhythmias, such as those with implantable cardioverter defibrillators (ICD) are particularly at risk. While ICDs can be life saving, many patients (including those without prior psychiatric illness) develop elevated rates of anxiety and depression, particularly after receiving discharges (shocks) from the device. Treatments involving modulation of the breath have been shown to improve both psychological and cardiac outcomes in patients with AF. Since breathing modulation alters sympathetic balance, this may be a mechanism of the therapeutic effect. This study examines the impact of a breathing training intervention on cardiorespiratory sensations and anxiety in adults with atrial and ventricular cardiac arrhythmias.

Eligibility criteria: Inclusion Criteria:

* Age 18 to 80
* BMI 17 to 35
* Proficient in English language
* Paroxysmal atrial fibrillation or ventricular fibrillation or frequent premature atrial/ventricular contractions

Exclusion Criteria:

* No telephone access
* Active suicidal ideation with intent or plan
* Active drug or alcohol dependence, or active binge drinking within the last month
* Cardiovascular instability, as evidenced any of the following:

  1. New York Heart Association (NHYA) heart failure class IV (i.e., unable to carry on any physical activity without discomfort, symptoms of heart failure at rest, increased discomfort with any physical activity is undertaken)
  2. American College of Cardiology/American Heart Association congestive heart failure stage D (i.e., heart failure symptoms at rest, receiving end of life care).
  3. Unstable angina or exercise induced angina
  4. Persistent atrial fibrillation
* Pacemakers or combined pacemaker/ICDs will be excluded
* Presence of unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic disease; or any other condition that, in the opinion of the investigator, would make participation not be in the best interest (e.g., compromise the well-being) of the subject or that could prevent, limit, or confound the protocol-specified assessments.

Primary outcomes:
measure: Cardiac anxiety
timeFrame: 1 month
Secondary outcomes:
measure: Disability
timeFrame: 1 month
measure: Wellbeing
timeFrame: 1 month
measure: ICD anxiety
timeFrame: 1 month
measure: Arrhythmia burden
timeFrame: 1 month
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: Laureate Institute for Brain Research
state: Oklahoma
Study officials:
affiliation: Laureate Institute for Brain Research
name: Sahib Khalsa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: