Clinical trial NCT02421341: Mechanisms of Altered Ventilatory Control in Heart Failure
Official title: Mechanisms of Altered Ventilatory Control in Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Heart, Cardiovascular
Pulmonary
Skeletal Muscle
Exercise
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2015-04-20
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Capacity to exercise (gas exchange analysis, borg scale questions, and medical doctor supervision)
timeFrame: An expected average of 4 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic - Saint Marys Hospital
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Thomas Olson, PhD
role: PRINCIPAL_INVESTIGATOR
References: