Mechanisms of Altered Ventilatory Control in Heart Failure

Mayo Clinic

Status: Completed

Conditions: Heart Failure

Treatments: Radiation: DEXA; Drug: Fentanyl; Procedure: Catheters; Other: Pulmonary Function Tests; Other: Chemosensitivity Test; Other: Blood Draw; Drug: Placebo; Other: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT02421341

12-005318

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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28 participants in 2 patient groups, including a placebo group

Drug - Fentanyl

Experimental group

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.

Treatment:

Procedure: Catheters

Other: Exercise

Radiation: DEXA

Other: Pulmonary Function Tests

Other: Chemosensitivity Test

Other: Blood Draw

Drug: Fentanyl

Placebo

Placebo Comparator group

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.

Treatment:

Procedure: Catheters

Other: Exercise

Radiation: DEXA

Other: Pulmonary Function Tests

Drug: Placebo

Other: Chemosensitivity Test

Other: Blood Draw