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

NCT02007486 | Unknown

• 1 other identifier: MCRDF 2013
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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 testing

  Patients will be followed until all study visits are complete, an expected average of 2 weeks.

Study Arms (4)

Heart Failure: NYHA functional class I

Ambulatory and clinically-stable patients with New York Heart Association Functional Class I heart failure and a left ventricular ejection fraction (LVEF) on echocardiography of \<45%.

Other: Cardiopulmonary Exercise Testing

Heart Failure: NYHA functional class II

Ambulatory and clinically-stable patients with New York Heart Association Functional Class II heart failure and a left ventricular ejection fraction (LVEF) on echocardiography of \<45%.

Other: Cardiopulmonary Exercise Testing

Heart Failure: NYHA functional class III

Ambulatory and clinically-stable patients with New York Heart Association Functional Class III heart failure and a left ventricular ejection fraction (LVEF) on echocardiography of \<45%.

Other: Cardiopulmonary Exercise Testing

Healthy Control Subjects

Healthy, sedentary, non-smoking, age- and sex-matched control subjects.

Other: Cardiopulmonary Exercise Testing

Interventions

Cardiopulmonary Exercise Testing OTHER

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

Healthy Control Subjects; Heart Failure: NYHA functional class I; Heart Failure: NYHA functional class II; Heart Failure: NYHA functional class III

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Ambulatory, male and female heart failure patients (n=24) will be recruited from the Heart Failure and Heart Transplant Centre of the Royal Victoria Hospital, McGill University Health Centre. Healthy, sedentary, non-smoking, asymptomatic, control subjects (n=8) will be recruited through advertisement in the Montréal and surrounding area

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Male or Female
• Greater than or equal to 40 years
• Non-smoker

Sponsors & Collaborators

• McGill University: lead

Study Sites (1)

McConnell Centre for Innovative Medicine, Research Institute of the McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

Related Links

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

MeSH Terms

Conditions

Heart Failure; Motor Activity; Dyspnea

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Behavior; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Dennis Jensen, Ph.D.

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 28, 2013
• First Posted: December 10, 2013
• Study Start: January 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 14, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)