Mechanisms of Altered Ventilatory Control in Heart Failure
1 other identifier
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable heart-failure
Started Jul 2012
Longer than P75 for not_applicable heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 25, 2015
CompletedFirst Posted
Study publicly available on registry
April 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 21, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 21, 2019
CompletedDecember 16, 2021
December 1, 2021
7 years
February 25, 2015
December 1, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Capacity to exercise (gas exchange analysis, borg scale questions, and medical doctor supervision)
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.
Study Arms (2)
Drug - Fentanyl
EXPERIMENTALStudy 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.
Placebo
PLACEBO COMPARATORStudy 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.
Interventions
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.
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.
You will be asked to exercise, ride a stationary bike, at maximal exertion.
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.
You will have approximately 350 mls (1.25 cups) of blood drawn during the duration of this study.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic - Saint Marys Hospital
Rochester, Minnesota, 55901, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Olson, PhD
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
February 25, 2015
First Posted
April 20, 2015
Study Start
July 1, 2012
Primary Completion
June 21, 2019
Study Completion
June 21, 2019
Last Updated
December 16, 2021
Record last verified: 2021-12