Heart FailureNCT02007486
Pathophysiological Mechanisms of Activity-Related Dyspnea in Heart Failure: A Pilot Study
An observational study of Heart Failure, run by McGill University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Cardiopulmonary Exercise Testing
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2014to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
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- Left Ventricular Ejection Fraction on echocardiography of less than or equal to 45% determined in the preceding 12-months.
- Male or Female
- Greater than or equal to 40 years
- Non-smoker
Who cannot join
- 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
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- 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.
- 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)
Trial locations and contacts
1 site in 1 country.
Canada1 site
McConnell Centre for Innovative Medicine, Research Institute of the McGill University Health Centre
Montreal, Quebec, H4A 3J1
About this study
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
- Being tested
- Cardiopulmonary Exercise Testing
- Keywords
- Heart Failure, Exercise, Dyspnea, Diaphragm electromyogram, Respiratory mechanics
- Medical subject headings
- Heart Failure, Motor Activity, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiopulmonary Exercise TestingOther
Symptom-limited incremental exercise testing (10 watts/min) on an electronically braked cycle ergometer
| Study group | Role | What they receive |
|---|---|---|
| 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%. Receives: 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%. Receives: 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%. Receives: Other: Cardiopulmonary Exercise Testing | |
| Healthy Control Subjects | Healthy, sedentary, non-smoking, age- and sex-matched control subjects. Receives: Other: Cardiopulmonary Exercise Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory intensity (Borg 0-10 scale) ratings of dyspnea at a standardized sub-maximal work rate during exercise
Measured: 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.
Measured: 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
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.
Measured: Patients will be followed until all study visits are complete, an expected average of 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dennis Jensen, Ph.D., McGill University
- Investigators
- Dennis Jensen, Ph.D., Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02007486
- Sponsor's protocol ID
- MCRDF 2013
- Status last verified
- Feb 2017
- First submitted
- 28 Nov 2013
- Last updated
- 14 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathophysiological Mechanisms of Activity-Related Dyspnea in Heart Failure: A Pilot Study
- ClinicalTrials.gov ID
- NCT02007486
- Acronym / sponsor ID
- MCRDF 2013
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Exercise, Dyspnea, Diaphragm electromyogram, Respiratory mechanics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 10 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Heart Failure: NYHA functional class I | – | Other: Cardiopulmonary Exercise TestingAmbulatory 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%. |
| Heart Failure: NYHA functional class II | – | Other: Cardiopulmonary Exercise TestingAmbulatory 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%. |
| Heart Failure: NYHA functional class III | – | Other: Cardiopulmonary Exercise TestingAmbulatory 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%. |
| Healthy Control Subjects | – | Other: Cardiopulmonary Exercise TestingHealthy, sedentary, non-smoking, age- and sex-matched control subjects. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiopulmonary Exercise TestingSymptom-limited incremental exercise testing (10 watts/min) on an electronically braked cycle ergometer | Other | Healthy Control Subjects, Heart Failure: NYHA functional class I, Heart Failure: NYHA functional class II, Heart Failure: NYHA functional class III |
Primary outcome
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
2 secondary outcomes
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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2017.
- Clinical Exercise \& Respiratory Physiology Laboratory (CERPL) of McGill UniversityLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis Jensen, Ph.D. principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by McGill University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2017.