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Completed

NCT Number: NCT02421341

Mechanisms of Altered Ventilatory Control in Heart Failure

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.

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Key information

Conditions

Heart Failure Behavior Cardiovascular Diseases Heart Diseases Motor Activity

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic - Saint Marys Hospital

Rochester, Minnesota, 55901, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fentanyl

Drug

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.

Other names: Analgesic, Opioid

Catheters

Procedure

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

Other

You will be asked to exercise, ride a stationary bike, at maximal exertion.

DEXA

Radiation

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

Other

During study visit one you will be asked to perform 5 different breathing tests to help us better understand your lung function.

Blood Draw

Other

You will have approximately 350 mls (1.25 cups) of blood drawn during the duration of this study.

Chemosensitivity Test

Other

Using a bag you breath in and out your own air.

Placebo

Drug

Primary outcomes

  1. Capacity to exercise (gas exchange analysis, borg scale questions, and medical doctor supervision)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Apr 20, 2015
Registry last updated
Dec 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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