- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02335684
Effects of Increased CF-LVAD Pump Speed During Sustained Submaximal Exercise
Improving Functional Capacity in Heart Failure Patients Supported With Continuous-flow Left Ventricular Assist Devices. -Effects of Increased Pump Speed During Sustained Submaximal Exercise
This randomized trial has been designed to study if it is possible to enhance work capacity during submaximal efforts in heart failure patients supported with continuous-flow left ventricular assist devices (CF-LVAD).
The hypothesis is that exercise tolerability during low to moderate workloads in CF-LVAD patients can be increased when pump speed is increased soon after the onset of exercise.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Copenhagen Oe, Denmark, 2100
- University Hospital of Copenhagen; Rigshospitalet.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Ischemic and non-ischemic cardiomyopathy patients with CF-LVADs,signed informed consent.
Exclusion Criteria:
- Unstable patients, CF-LVAD implantation less than three months ago.
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CF-LVAD patients.
Patients are compared with themselves during submaximal exercise testing with baseline pump speed vs. submaximal exercise testing with increased pump speed.
|
Submaximal exercise test with baseline pump speed.
Submaximal exercise test with increased pump speed (+800RPM).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exercise time
Time Frame: Exercise time will be estimated only on the day of the study. No follow-up.
|
Exercise will be performed on a upright ergometer bike with simultaneously breath-by-breath gaz analysis.
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Exercise time will be estimated only on the day of the study. No follow-up.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived exertion
Time Frame: Perceived exertion will be estimated during exercise on the ergometer bike on the day of the study.
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Rate of exertion will be estimated using the Borg Scale.
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Perceived exertion will be estimated during exercise on the ergometer bike on the day of the study.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart rate
Time Frame: Heart rate will be measures during exercise.
|
Heart rate is measured by ECG monitoring.
|
Heart rate will be measures during exercise.
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Anaerobic threshold
Time Frame: Anaerobic threshold is measured during exercise on the study day.
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Anaerobic threshold is defined as respiratory exchange rate (RER) >1.
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Anaerobic threshold is measured during exercise on the study day.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Finn Gustafsson, MD, Rigshospitalet, Denmark
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Heart Failure
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Dopamine Uptake Inhibitors
- Central Nervous System Stimulants
- Sympathomimetics
- Adrenergic Uptake Inhibitors
- Methamphetamine
Other Study ID Numbers
- H-1-2013-103
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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