Mechanisms of Altered Ventilatory Control in Heart Failure
NCT ID: NCT02421341
Last Updated: 2021-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
28 participants
INTERVENTIONAL
2012-07-31
2019-06-21
Brief Summary
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Detailed Description
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During study visit 1 you will be asked to get a blood draw, DEXA bone scan, perform pulmonary function tests, and exercise on a stationary bike at maximal exertion while breathing into a mouth piece.
During study visits 2 and 3 you will be asked to again exercise at maximal exertion while breathing into a mouth piece. However, during these two visits you will be receiving an intrathecal injection of fentanyl one day and placebo the other day, randomly selected and you will be blinded as to which you are receiving. A catheter will also be placed in an artery in your arm and a vein in your leg, which will help us to measure blood flow, blood pressure and draw blood when need be. The investigators will also ask you to perform a brief chemosensitivity test, breathing in and out your own air, after you are done exercising.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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Drug - Fentanyl
Study visit 1 you will be asked to get a blood draw, DEXA bone scan, perform pulmonary function tests, and exercise on a stationary bike at maximal exertion while breathing into a mouth piece. Study visits 2 and 3 you will be asked to again exercise at maximal exertion while breathing into a mouth piece. During these two visits you will be receiving an intrathecal injection of either fentanyl or placebo, randomly selected and you will be blinded as to which you are receiving. Catheters will also be placed in an artery in your arm and a vein in your leg, helping us to measure blood flow, blood pressure and draw blood. You will also perform a chemosensitivity test, breathing in and out your own air, after you are done exercising.
Fentanyl
During study visits 2 and 3 you will receive an intrathecal (fluid filled space surrounding the spinal cord) injection of either fentanyl or placebo (saline). Fentanyl is an opiate (narcotic) drug and a common medication, however the way fentanyl is being used in this study is considered investigational.
Catheters
A catheter (small plastic tube placed in a blood vessel) will be placed in an artery in your arm and a second catheter will be placed in a vein in your leg. Local anesthetic will be used to minimize discomfort. These catheters will allow us to measure blood pressure, leg blood flow and draw blood.
Exercise
You will be asked to exercise, ride a stationary bike, at maximal exertion.
DEXA
During study visit one you will have a DEXA scan. This procedure requires you to lie on a table while a small x-ray tube passes under your body.
Pulmonary Function Tests
During study visit one you will be asked to perform 5 different breathing tests to help us better understand your lung function.
Blood Draw
You will have approximately 350 mls (1.25 cups) of blood drawn during the duration of this study.
Chemosensitivity Test
Using a bag you breath in and out your own air.
Placebo
Study visit 1 you will be asked to get a blood draw, DEXA bone scan, perform pulmonary function tests, and exercise on a stationary bike at maximal exertion while breathing into a mouth piece. Study visits 2 and 3 you will be asked to again exercise at maximal exertion while breathing into a mouth piece. During these two visits you will be receiving an intrathecal injection of either fentanyl or placebo, randomly selected and you will be blinded as to which you are receiving. Catheters will also be placed in an artery in your arm and a vein in your leg, helping us to measure blood flow, blood pressure and draw blood. You will also perform a chemosensitivity test, breathing in and out your own air, after you are done exercising.
Catheters
A catheter (small plastic tube placed in a blood vessel) will be placed in an artery in your arm and a second catheter will be placed in a vein in your leg. Local anesthetic will be used to minimize discomfort. These catheters will allow us to measure blood pressure, leg blood flow and draw blood.
Exercise
You will be asked to exercise, ride a stationary bike, at maximal exertion.
DEXA
During study visit one you will have a DEXA scan. This procedure requires you to lie on a table while a small x-ray tube passes under your body.
Pulmonary Function Tests
During study visit one you will be asked to perform 5 different breathing tests to help us better understand your lung function.
Blood Draw
You will have approximately 350 mls (1.25 cups) of blood drawn during the duration of this study.
Chemosensitivity Test
Using a bag you breath in and out your own air.
Placebo
Interventions
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Fentanyl
During study visits 2 and 3 you will receive an intrathecal (fluid filled space surrounding the spinal cord) injection of either fentanyl or placebo (saline). Fentanyl is an opiate (narcotic) drug and a common medication, however the way fentanyl is being used in this study is considered investigational.
Catheters
A catheter (small plastic tube placed in a blood vessel) will be placed in an artery in your arm and a second catheter will be placed in a vein in your leg. Local anesthetic will be used to minimize discomfort. These catheters will allow us to measure blood pressure, leg blood flow and draw blood.
Exercise
You will be asked to exercise, ride a stationary bike, at maximal exertion.
DEXA
During study visit one you will have a DEXA scan. This procedure requires you to lie on a table while a small x-ray tube passes under your body.
Pulmonary Function Tests
During study visit one you will be asked to perform 5 different breathing tests to help us better understand your lung function.
Blood Draw
You will have approximately 350 mls (1.25 cups) of blood drawn during the duration of this study.
Chemosensitivity Test
Using a bag you breath in and out your own air.
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* New York Heart Association class 1-3
* No history of dangerous arrhythmia's
* Not pacemaker dependent
* Body Mass Index less than or equal to 35 kg/m
* Current non-smokers with less than 15 pack year history
* Non-pregnant women
* Individuals who are able to exercise without orthopedic limitations
Exclusion Criteria
* Will be matched for age, gender, height and weight and will have no history of cardiovascular related abnormalities.
* Body Mass Index less than 35 kg/m
* Current non-smokers with less than 15 pack year history
* Non-pregnant women
* Individuals who are able to exercise without orthopedic limitations
18 Years
90 Years
ALL
Yes
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Thomas P. Olson, M.S., Ph.D.
PI
Principal Investigators
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Thomas Olson, PhD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic - Saint Marys Hospital
Rochester, Minnesota, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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12-005318
Identifier Type: -
Identifier Source: org_study_id