Heart Failure
Conditions
Keywords
Heart, Cardiovascular, Pulmonary, Skeletal Muscle, Exercise
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.
Interventions
DRUGFentanyl
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.
PROCEDURECatheters
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.
OTHERExercise
You will be asked to exercise, ride a stationary bike, at maximal exertion.
RADIATIONDEXA
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.
During study visit one you will be asked to perform 5 different breathing tests to help us better understand your lung function.
OTHERBlood Draw
You will have approximately 350 mls (1.25 cups) of blood drawn during the duration of this study.
OTHERChemosensitivity Test
Using a bag you breath in and out your own air.
DRUGPlacebo
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Capacity to exercise (gas exchange analysis, borg scale questions, and medical doctor supervision) | An expected average of 4 hours. | Participants will be monitored during the duration of their exercise by gas exchange analysis, borg scale questions, and medical doctor supervision. |
Countries
United States
Outcome results
None listed