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Pathophysiological Mechanisms of Activity-Related Dyspnea in Heart Failure: A Pilot Study

Pathophysiological Mechanisms of Activity-Related Dyspnea in Heart Failure: A Pilot Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02007486
Enrollment
32
Registered
2013-12-10
Start date
2014-01-31
Completion date
2017-12-31
Last updated
2017-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Heart Failure, Exercise, Dyspnea, Diaphragm electromyogram, Respiratory mechanics

Brief summary

Dyspnea (breathlessness) on exertion is the most prevalent and distressing symptom of heart failure (HF). Nevertheless, the mechanisms of dyspnea in HF remain poorly understood. Thus, the general aim of this pilot study is to advance our understanding of the mechanisms of activity-related dyspnea in patients with HF. Studies will be performed in patients with mild, moderate and severe HF (n=24) as well as in healthy, age- and sex-matched control subjects (n=8). We will test the hypothesis that the increased prevalence and severity of activity-related dyspnea in HF reflects the interaction between an exaggerated drive to breathe and the inability of the respiratory system to meet this increased demand. Detailed physiological and perceptual responses to bicycle exercise will be examined and compared, first, between HF patients and healthy control subjects and, second, across patients with varying degrees of HF severity. The results from this preliminary study will be used to help design future studies in this patient population.

Interventions

OTHERCardiopulmonary Exercise Testing

Symptom-limited incremental exercise testing (10 watts/min) on an electronically braked cycle ergometer

Sponsors

McGill University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

for Heart Failure Patients: * Male or Female * Greater than or equal to 40 years * Greater than or equal to 6 month history of Heart Failure due to ischemic or idiopathic causes * New York Heart Association Functional Class I (n=8), II (n=8) and III (n=8) * Ambulatory * Clinically Stable, as evidenced by no change in medication dosage or frequency of administration and no exacerbations or hospitalizations due to Heart Failure in the preceding 3-months * Left Ventricular Ejection Fraction on echocardiography of less than or equal to 45% determined in the preceding 12-months.

Exclusion criteria

for Heart Failure Patients: * Chronic obstructive lung disease and/or active disease other than Heart Failure (e.g., bronchial asthma; pulmonary arterial hypertension that is not considered secondary to left heart failure; peripheral artery disease; primary valvular disease; neurological, cognitive, neuromuscular, endocrine, kidney, metabolic and/or musculoskeletal disease) * Unstable angina * Intermittent claudication * History of dangerous cardiac arrhythmias * Myocardial infarction and/or stroke in the preceding 6-months * Use of a pacemaker or cardiac resynchronization device * Use of domiciliary oxygen and/or exercise-induced arterial oxyhemoglobin desaturation to \<80% on room air * Current and/or ex-smoker with a cigarette smoking history of greater than or equal to 10 pack years * Body mass index less than 18.5 or greater than or equal to 35.0 kg/m2 * Use of antidepressant, opioid and/or anti-coagulant drugs in the preceding 4-weeks * Evidence of periodic breathing (or oscillatory ventilation) on initial exercise testing * Evidence of significant sleep-disordered breathing (i.e., apnea-hypopnea index \>15 events/hour of sleep) based on overnight polysomnography performed within preceding 12-months. Inclusion Criteria for Healthy Control Subjects: * Male or Female * Greater than or equal to 40 years * Non-smoker

Design outcomes

Primary

MeasureTime frame
Sensory intensity (Borg 0-10 scale) ratings of dyspnea at a standardized sub-maximal work rate during exercisePatients will be followed until all study visits are complete, an expected average of 2 weeks

Secondary

MeasureTime frameDescription
Esophageal electrode catheter-derived measurements of the diaphragm EMG at a standardized sub-maximal work rate during exercise.Patients will be followed until all study visits are complete, an expected average of 2 weeks
Power output (measured in watts) at the symptom-limited peak of incremental cycle ergometer exercise testingPatients will be followed until all study visits are complete, an expected average of 2 weeks.The highest power output (measured in watts) that the study participants are able to sustain for greater than or equal to 30 seconds will be defined as the symptom-limited peak power output and used as a secondary outcome measure in this study.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026