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

February 10, 2017 updated by: Dennis Jensen, Ph.D., McGill University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • McConnell Centre for Innovative Medicine, Research Institute of the McGill University Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Symptom-limited incremental exercise testing (10 watts/min) on an electronically braked cycle ergometer
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
Symptom-limited incremental exercise testing (10 watts/min) on an electronically braked cycle ergometer
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
Symptom-limited incremental exercise testing (10 watts/min) on an electronically braked cycle ergometer
Healthy Control Subjects
Healthy, sedentary, non-smoking, age- and sex-matched control subjects.
Other: Cardiopulmonary Exercise Testing
Symptom-limited incremental exercise testing (10 watts/min) on an electronically braked cycle ergometer

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Sensory intensity (Borg 0-10 scale) ratings of dyspnea at a standardized sub-maximal work rate during exercise
Time Frame: Patients will be followed until all study visits are complete, an expected average of 2 weeks
Patients will be followed until all study visits are complete, an expected average of 2 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Esophageal electrode catheter-derived measurements of the diaphragm EMG at a standardized sub-maximal work rate during exercise.
Time Frame: Patients will be followed until all study visits are complete, an expected average of 2 weeks
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
Time Frame: Patients 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.
Patients will be followed until all study visits are complete, an expected average of 2 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
McGill University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 28, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 10, 2013

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 14, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MCRDF 2013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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