Clinical trial NCT00005688: Cardiac Arrhythmias and the Perception of Symptoms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Arrhythmia
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To investigate the differential diagnosis and longitudinal course of medical outpatients complaining of palpitations. Also, to further examine the process of cardiac perception, the psychological factors which influence it, and the accurate awareness of cardiac arrhythmias.

Detailed description: DESIGN NARRATIVE:

One hundred seventy-five consecutive patients referred for continuous ambulatory electrocardiographic (Holter) monitoring because of palpitations were studied. The investigators assessed cardiac symptoms, psychiatric diagnosis, life stress, beliefs about heart disease, somatization, and bodily absorption and amplification. Cardiac awareness, cardiac symptoms and cardiac activity were assessed during Holter monitoring and exercise tolerance testing (ETT). The referring physicians completed instruments rating their diagnostic impressions and clinical interventions. The patients' clinical course was then followed over the ensuing 12 months with telephone interviews and in-person assessments. These data permitted description and distinguished three subgroups of palpitation patients: those with panic disorder, in whom the symptom resulted from sympathetic nervous system arousal; those who were somatizing after a life event caused them to suspect that they had heart disease, in whom the palpitation resulted from a cognitive misattribution of benign bodily sensation; and those with clinically significant arrhythmias, whose symptoms resulted from a major cardiac irregularity. These findings were used to develop a clinical algorithm to aid in the differential diagnosis of palpitations and in identifying the patients most appropriate for Holter monitoring.

The patients' longitudinal course was followed to determine the predictors of continued somatization and chronicity, and to study their medical care by examining the referring physicians' diagnostic impressions and interventions. By comparing cardiac symptoms with concurrent cardiac activity during Holter monitoring and ETT, the investigators hoped to develop measures of cardiac awareness. They would then be able to describe inter-individual differences in cardiac awareness, examine several psychological factors which amplify or modulate awareness, and investigate the relationship between somatization and accuracy of symptom reporting. It was hoped that the findings would ultimately lead to improved cognitive and educational techniques to reassure and palliate palpitation patients, and to the early identification of patients who were unlikely to obtain symptomatic relief from antiarrhythmic therapy.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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