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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02007486
• Other study ID #: MCRDF 2013
• Status: Active, not recruiting
• Phase: N/A
• First received: November 28, 2013
• Last updated: February 10, 2017
• Start date: January 2014
• Est. completion date: December 2017

Study information

• Verified date: February 2017
• Source: McGill University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Exclusion Criteria for Healthy Control Subjects:

• History of cardiovascular, cerebrovascular, pulmonary, musculoskeletal, neuromuscular, renal, endocrine, metabolic, neurologic and/or cognitive disease/dysfunction.

• Evidence of exercise-induced myocardial ischemia on ECG

• Evidence of exercise-induced oxyhemoglobin desaturation to <80% on room air

• Taking regular medication(s)

Related Conditions & MeSH terms

• Dyspnea
• Heart Failure

Intervention

Other:
• Cardiopulmonary Exercise Testing
Symptom-limited incremental exercise testing (10 watts/min) on an electronically braked cycle ergometer

Locations

Country	Name	City	State
Canada	McConnell Centre for Innovative Medicine, Research Institute of the McGill University Health Centre	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensory intensity (Borg 0-10 scale) ratings of dyspnea 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
Secondary	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
Secondary	Power output (measured in watts) at the symptom-limited peak of incremental cycle ergometer exercise testing	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.	Patients will be followed until all study visits are complete, an expected average of 2 weeks.

External Links

•   Clinical Exercise & Respiratory Physiology Laboratory (CERPL) of McGill University