Heart FailureNCT02421341
Mechanisms of Altered Ventilatory Control in Heart Failure
A study testing Fentanyl, Catheters and Exercise in people with Heart Failure, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Fentanyl, Catheters and Exercise
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to 21 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic - Saint Marys Hospital
Rochester, Minnesota, 55901
About this study
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Fentanyl, Catheters, Exercise, DEXA, Pulmonary Function Tests
- Keywords
- Heart, Cardiovascular, Pulmonary, Skeletal Muscle, Exercise
- Medical subject headings
- Heart Failure, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
Also called Analgesic, Opioid
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.
CathetersProcedure or surgery
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.
ExerciseOther
You will be asked to exercise, ride a stationary bike, at maximal exertion.
DEXARadiation
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 TestsOther
During study visit one you will be asked to perform 5 different breathing tests to help us better understand your lung function.
Blood DrawOther
You will have approximately 350 mls (1.25 cups) of blood drawn during the duration of this study.
Chemosensitivity TestOther
Using a bag you breath in and out your own air.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Drug - Fentanyl | Experimental | 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. Receives: Drug: Fentanyl; Procedure: Catheters; Other: Exercise; Radiation: DEXA; Other: Pulmonary Function Tests; Other: Blood Draw; Other: Chemosensitivity Test |
| Placebo | Placebo comparator | 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. Receives: Procedure: Catheters; Other: Exercise; Radiation: DEXA; Other: Pulmonary Function Tests; Other: Blood Draw; Other: Chemosensitivity Test; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: An expected average of 4 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2015 (estimated)
- Study startJul 2012
- Primary completion21 Jun 2019
- Study completion21 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas P. Olson, M.S., Ph.D., Mayo Clinic
- Investigators
- Thomas Olson, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02421341
- Sponsor's protocol ID
- 12-005318
- Status last verified
- Dec 2021
- First submitted
- 25 Feb 2015
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Altered Ventilatory Control in Heart Failure
- ClinicalTrials.gov ID
- NCT02421341
- Acronym / sponsor ID
- 12-005318
- Conditions
- Heart Failure
- Keywords
- Heart, Cardiovascular, Pulmonary, Skeletal Muscle, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- 21 Jun 2019 (actual)
- Study completion
- 21 Jun 2019 (actual)
- First posted
- 20 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug - Fentanyl | Experimental | Drug: Fentanyl, Procedure: Catheters, Other: Exercise, Radiation: DEXA, Other: Pulmonary Function Tests, Other: Blood Draw, Other: Chemosensitivity TestStudy 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 comparator | Procedure: Catheters, Other: Exercise, Radiation: DEXA, Other: Pulmonary Function Tests, Other: Blood Draw, Other: Chemosensitivity Test, Drug: PlaceboStudy 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FentanylAlso: Analgesic, OpioidDuring 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. | Drug | Drug - Fentanyl |
| CathetersA 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. | Procedure or surgery | Drug - Fentanyl, Placebo |
| ExerciseYou will be asked to exercise, ride a stationary bike, at maximal exertion. | Other | Drug - Fentanyl, Placebo |
| DEXADuring 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. | Radiation | Drug - Fentanyl, Placebo |
| Pulmonary Function TestsDuring study visit one you will be asked to perform 5 different breathing tests to help us better understand your lung function. | Other | Drug - Fentanyl, Placebo |
| Blood DrawYou will have approximately 350 mls (1.25 cups) of blood drawn during the duration of this study. | Other | Drug - Fentanyl, Placebo |
| Chemosensitivity TestUsing a bag you breath in and out your own air. | Other | Drug - Fentanyl, Placebo |
| Placebo | Drug | Placebo |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Olson, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fentanyl, Catheters and Exercise in people with Heart Failure, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Capacity to exercise (gas exchange analysis, borg scale questions, and medical doctor supervision) (time frame: An expected average of 4 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2021.