Back to resultsMechanisms of Altered Ventilatory Control in Heart Failure
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fentanyl
Catheters
Exercise
DEXA
Pulmonary Function Tests
Blood Draw
Chemosensitivity Test
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Heart Failure focused on measuring Heart, Cardiovascular, Pulmonary, Skeletal Muscle, Exercise
Eligibility Criteria
Inclusion Criteria (Heart Failure Patients):
- History of ischemic or idiopathic dilated cardiomyopathy
- 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
- All patients will be managed by their primary care physician or cardiologist prior to enrollment to ensure inclusion and exclusion criteria have been satisfied and participation in exercise testing is safe.
Control Participants:
- 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
Sites / Locations
- Mayo Clinic - Saint Marys Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Drug - Fentanyl
Placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Capacity to exercise (gas exchange analysis, borg scale questions, and medical doctor supervision)
Participants will be monitored during the duration of their exercise by gas exchange analysis, borg scale questions, and medical doctor supervision.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02421341
Brief Title
Mechanisms of Altered Ventilatory Control in Heart Failure
Official Title
Mechanisms of Altered Ventilatory Control in Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
June 21, 2019 (Actual)
Study Completion Date
June 21, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is being done because the investigators are trying to understand how feedback from the muscles can influence your blood pressure and breathing during exercise, and if the investigators can reduce this response in heart failure patients. The investigators are also trying to determine ways to improve tolerance to exercise in heart failure patients.
Detailed Description
If you are enrolled in this study the investigators will ask you to make 3 separate study visits.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart, Cardiovascular, Pulmonary, Skeletal Muscle, Exercise
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Drug - Fentanyl
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Other Intervention Name(s)
Analgesic, Opioid
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Catheters
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
You will be asked to exercise, ride a stationary bike, at maximal exertion.
Intervention Type
Radiation
Intervention Name(s)
DEXA
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Pulmonary Function Tests
Intervention Description
During study visit one you will be asked to perform 5 different breathing tests to help us better understand your lung function.
Intervention Type
Other
Intervention Name(s)
Blood Draw
Intervention Description
You will have approximately 350 mls (1.25 cups) of blood drawn during the duration of this study.
Intervention Type
Other
Intervention Name(s)
Chemosensitivity Test
Intervention Description
Using a bag you breath in and out your own air.
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Capacity to exercise (gas exchange analysis, borg scale questions, and medical doctor supervision)
Description
Participants will be monitored during the duration of their exercise by gas exchange analysis, borg scale questions, and medical doctor supervision.
Time Frame
An expected average of 4 hours.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria (Heart Failure Patients):
History of ischemic or idiopathic dilated cardiomyopathy
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
All patients will be managed by their primary care physician or cardiologist prior to enrollment to ensure inclusion and exclusion criteria have been satisfied and participation in exercise testing is safe.
Control Participants:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Olson, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic - Saint Marys Hospital
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55901
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Mechanisms of Altered Ventilatory Control in Heart Failure
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