Mechanisms of Altered Ventilatory Control in Heart Failure

December 1, 2021 updated by: Thomas P. Olson, M.S., Ph.D., Mayo Clinic
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55901
        • Mayo Clinic - Saint Marys Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Drug - Fentanyl
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.
Drug: Fentanyl
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
Procedure: Catheters
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.
Other: Exercise
You will be asked to exercise, ride a stationary bike, at maximal exertion.
Radiation: DEXA
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.
Other: Pulmonary Function Tests
During study visit one you will be asked to perform 5 different breathing tests to help us better understand your lung function.
Other: Blood Draw
You will have approximately 350 mls (1.25 cups) of blood drawn during the duration of this study.
Other: Chemosensitivity Test
Using a bag you breath in and out your own air.
Placebo Comparator: Placebo
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.
Drug: Placebo
Procedure: Catheters
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.
Other: Exercise
You will be asked to exercise, ride a stationary bike, at maximal exertion.
Radiation: DEXA
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.
Other: Pulmonary Function Tests
During study visit one you will be asked to perform 5 different breathing tests to help us better understand your lung function.
Other: Blood Draw
You will have approximately 350 mls (1.25 cups) of blood drawn during the duration of this study.
Other: Chemosensitivity Test
Using a bag you breath in and out your own air.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
An expected average of 4 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Thomas Olson, PhD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

June 21, 2019

Study Completion (Actual)

June 21, 2019

Study Registration Dates

First Submitted

February 25, 2015

First Submitted That Met QC Criteria

April 17, 2015

First Posted (Estimate)

April 20, 2015

Study Record Updates

Last Update Posted (Actual)

December 16, 2021

Last Update Submitted That Met QC Criteria

December 1, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-005318

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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