Heart Failure，CongestiveIRONMANNCT03078972
Effect of mechanIcal circulatoRy Support ON Exercise Capacity aMong pAtieNts With Heart Failure
An observational study of Heart Failure，Congestive, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study will evaluate how the cardiovascular system interacts with mechanical hearts to provide blood flow to the body during exercise. Two aims are proposed: 1) to determine the impact of a mechanical heart on exercise pressor reflexes in heart failure patients; and 2) to define the primary determinant(s) of… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure，Congestive
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2017to 30 Jun 2023
- Phase
- Observational
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 40 - HF patients with advanced heart failure who are scheduled to undergo LVAD insertion (Advanced Heart Failure) 10 - HF patients with mild heart failure who are not scheduled to undergo LVAD insertion, to serve as first control group (Mild Heart Failure) 10 - Age-matched healthy individuals, with no past medical history, to serve as a second control group (Healthy Controls)
Who may be able to join
- Individuals with severely reduced left ventricular systolic function that are scheduled to undergo LVAD insertion
- Individuals with medically managed left ventricular systolic function that are NOT scheduled to undergo LVAD insertion
- HF patients with ejection fraction <35-40%
- Persons without a past medical history of cardiovascular disease or related disease (e.g. hypertension, diabetes, peripheral vascular disease, arrhythmias, stroke/transient ischemic attack) and are not taking any cardiac-related medications (e.g. antihypertensive medications)
Who cannot join
- uncontrolled diabetes with peripheral neuropathy (interferes with acquisition of MSNA signal)
- Individuals with clinical right ventricular failure, defined as moderate-severely reduced RV systolic function on echocardiography, or clinical evidence of RV failure (elevated jugular venous pressures, significant peripheral edema)
- Individuals with moderate-severe preexisting aortic insufficiency, as these patients will typically undergo a Park stitch at time of CF-LVAD insertion to permanently close the aortic valve and prevent worsening aortic insufficiency; and
- Disorders that adversely influence exercise ability (e.g. arthritis, peripheral vascular disease, pulmonary disease)
- Mild Heart Failure -
- Individuals requiring systemic anticoagulation with vitamin-K antagonists or new/direct oral anticoagulants ("NOAC"/"DOAC")
Show all 11Show fewer
- Disorders that adversely influence exercise ability (e.g. arthritis, peripheral vascular disease, pulmonary disease)
- History of uncontrolled arrhythmias (e.g. ventricular tachycardia or nonsustained ventricular tachycardia).
- Healthy Controls -
- Individuals requiring systemic anticoagulation with vitamin-K antagonists or new/direct oral anticoagulants ("NOAC"/"DOAC")
- Disorders that adversely influence exercise ability (e.g. arthritis, peripheral ascular disease).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Snschutz Medical Campus
Aurora, Colorado, 80045
About this study
Official title: Effective Mechanical Circulatory Support on Exercise Capacity in Heart Failure
This study will evaluate how the cardiovascular system interacts with mechanical hearts to provide blood flow to the body during exercise. Two aims are proposed: 1) to determine the impact of a mechanical heart on exercise pressor reflexes in heart failure patients; and 2) to define the primary determinant(s) of exercise capacity in heart failure patients before and after device implantation.
- Conditions
- Heart Failure，Congestive
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Advanced Heart Failure | 40 patients with advanced heart failure scheduled to undergo Left Ventricular Assist Device (LVAD) insertion will be recruited for testing. Test subjects will complete testing prior to, and following LVAD implantation. | |
| Healthy controls | 10 age-matched healthy individuals will be recruited to establish normal/reference values. | |
| Mild Heart Failure | A second control group comprised of 10 age-matched individuals will be recruited to establish normal/reference values for individuals with mild, medically managed heart failure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the sympathetic neural response.
The primary outcome will be the difference in the muscle sympathetic neural response (MSNA) to handgrip and post-exercise circulatory arrest (PECA) before and after Continuous-flow left ventricular assist device (CF-LVAD) insertion
Measured: 4 weeks prior to implantation and 6 months post implantation.
Change in VO2.
The primary outcome will be the change in the VO2 (maximum rate of oxygen consumption) before and after CF-LVAD insertion.
Measured: 4 weeks prior to implantation and 6 months post implantation.
Secondary outcomes (6)
Changes in the hemodynamic response.
This outcome will evaluate any difference in the hemodynamic response (heart rate and blood pressure) to handgrip and PECA before and after CF-LVAD
Measured: 4 weeks prior to implantation and 6 months post implantation.
VO2 relationship and ventilatory threshold (1)
Cardiac output (Qc): VO2 relationship and ventilatory threshold before and after CF-LVAD insertion.
Measured: 4 weeks prior to implantation and 6 months post implantation.
VO2 relationship and ventilatory threshold (2).
Determinants of Qc after CF-LVAD insertion (ie, contribution from device v. contribution from left ventricle).
Measured: 4 weeks prior to implantation and 6 months post implantation.
VO2 relationship and ventilatory threshold (3).
Qc, VO2, ventilatory threshold and exercise capacity at increased pump speed.
Measured: 4 weeks prior to implantation and 6 months post implantation.
VO2 relationship and ventilatory threshold (4).
Bloodflow to the periphery, as measured by transcranial Doppler to assess brain bloodflow during exercise/activity.
Measured: 4 weeks prior to implantation and 6 months post implantation.
Oxygen uptake and utilization
Cerebral and musculoskeletal oxygen uptake by near-infrared spectroscopy
Measured: 4 weeks prior to implantation and 6 months post implantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2017
- Study start7 Apr 2017
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart Failure，CongestiveStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William K Cornwell, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03078972
- Sponsor's protocol ID
- 16-1635
- Acronym
- IRONMAN
- Status last verified
- May 2023
- First submitted
- 28 Feb 2017
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Buchanan C, Buchanan C, Riordan M, Byrd J, Schulte M, Kohrt WM, Ambardekar AV, Allen LA, Wolfel G, Lawley J, Levine BD, Cornwell WK 3rd. Cardiopulmonary Performance Among Heart Failure Patients Before and After Left Ventricular Assist Device Implantation. JACC Heart Fail. 2024 Jan;12(1):117-129. doi: 10.1016/j.jchf.2023.06.017. Epub 2023 Aug 23.
PubMed 37632493Edward JA, Parker H, Stohr EJ, McDonnell BJ, O'Gean K, Schulte M, Lawley JS, Cornwell WK 3rd. Exertional Cardiac and Pulmonary Vascular Hemodynamics in Patients With Heart Failure With Reduced Ejection Fraction. J Card Fail. 2023 Sep;29(9):1276-1284. doi: 10.1016/j.cardfail.2023.01.010. Epub 2023 Mar 5.
PubMed 36871613Sailer C, Edelmann H, Buchanan C, Giro P, Babcock M, Swanson C, Spotts M, Schulte M, Pratt-Cordova A, Coe G, Beindorff M, Page RL 2nd, Ambardekar AV, Pal JD, Kohrt W, Wolfel E, Lawley JS, Tarumi T, Cornwell WK 3rd. Impairments in Blood Pressure Regulation and Cardiac Baroreceptor Sensitivity Among Patients With Heart Failure Supported With Continuous-Flow Left Ventricular Assist Devices. Circ Heart Fail. 2021 Jan;14(1):e007448. doi: 10.1161/CIRCHEARTFAILURE.120.007448. Epub 2021 Jan 19.
PubMed 33464953
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective Mechanical Circulatory Support on Exercise Capacity in Heart Failure
- ClinicalTrials.gov ID
- NCT03078972
- Acronym / sponsor ID
- IRONMAN / 16-1635
- Conditions
- Heart Failure，Congestive
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 7 Apr 2017 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 14 Mar 2017 (actual)
- 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 will evaluate how the cardiovascular system interacts with mechanical hearts to provide blood flow to the body during exercise. Two aims are proposed: 1) to determine the impact of a mechanical heart on exercise pressor reflexes in heart failure patients; and 2) to define the primary determinant(s) of exercise capacity in heart failure patients before and after device implantation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Advanced Heart Failure | – | –40 patients with advanced heart failure scheduled to undergo Left Ventricular Assist Device (LVAD) insertion will be recruited for testing. Test subjects will complete testing prior to, and following LVAD implantation. |
| Healthy controls | – | –10 age-matched healthy individuals will be recruited to establish normal/reference values. |
| Mild Heart Failure | – | –A second control group comprised of 10 age-matched individuals will be recruited to establish normal/reference values for individuals with mild, medically managed heart failure. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 40 - HF patients with advanced heart failure who are scheduled to undergo LVAD insertion (Advanced Heart Failure) 10 - HF patients with mild heart failure who are not scheduled to undergo LVAD insertion, to serve as first control group (Mild Heart Failure) 10 - Age-matched healthy individuals, with no past medical history, to serve as a second control group (Healthy Controls)
Key inclusion criteria (4 listed)
- Individuals with severely reduced left ventricular systolic function that are scheduled to undergo LVAD insertion
- Individuals with medically managed left ventricular systolic function that are NOT scheduled to undergo LVAD insertion
- HF patients with ejection fraction <35-40%
- Persons without a past medical history of cardiovascular disease or related disease (e.g. hypertension, diabetes, peripheral vascular disease, arrhythmias, stroke/transient ischemic attack) and are not taking any cardiac-related medications (e.g. antihypertensive medications)
Key exclusion criteria (11 listed)
- uncontrolled diabetes with peripheral neuropathy (interferes with acquisition of MSNA signal)
- Individuals with clinical right ventricular failure, defined as moderate-severely reduced RV systolic function on echocardiography, or clinical evidence of RV failure (elevated jugular venous pressures, significant peripheral edema)
- Individuals with moderate-severe preexisting aortic insufficiency, as these patients will typically undergo a Park stitch at time of CF-LVAD insertion to permanently close the aortic valve and prevent worsening aortic insufficiency; and
- Disorders that adversely influence exercise ability (e.g. arthritis, peripheral vascular disease, pulmonary disease)
- Mild Heart Failure -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in the sympathetic neural response.
Time frame: 4 weeks prior to implantation and 6 months post implantation.
The primary outcome will be the difference in the muscle sympathetic neural response (MSNA) to handgrip and post-exercise circulatory arrest (PECA) before and after Continuous-flow left ventricular assist device (CF-LVAD) insertion
Change in VO2.
Time frame: 4 weeks prior to implantation and 6 months post implantation.
The primary outcome will be the change in the VO2 (maximum rate of oxygen consumption) before and after CF-LVAD insertion.
6 secondary outcomes
Changes in the hemodynamic response.
Time frame: 4 weeks prior to implantation and 6 months post implantation.
VO2 relationship and ventilatory threshold (1)
Time frame: 4 weeks prior to implantation and 6 months post implantation.
VO2 relationship and ventilatory threshold (2).
Time frame: 4 weeks prior to implantation and 6 months post implantation.
VO2 relationship and ventilatory threshold (3).
Time frame: 4 weeks prior to implantation and 6 months post implantation.
VO2 relationship and ventilatory threshold (4).
Time frame: 4 weeks prior to implantation and 6 months post implantation.
Oxygen uptake and utilization
Time frame: 4 weeks prior to implantation and 6 months post implantation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Derived from this study: PubMed 37632493Buchanan C, Buchanan C, Riordan M, Byrd J, Schulte M, Kohrt WM, Ambardekar AV, Allen LA, Wolfel G, Lawley J, Levine BD, Cornwell WK 3rd. Cardiopulmonary Performance Among Heart Failure Patients Before and After Left Ventricular Assist Device Implantation. JACC Heart Fail. 2024 Jan;12(1):117-129. doi: 10.1016/j.jchf.2023.06.017. Epub 2023 Aug 23.
- Derived from this study: PubMed 36871613Edward JA, Parker H, Stohr EJ, McDonnell BJ, O'Gean K, Schulte M, Lawley JS, Cornwell WK 3rd. Exertional Cardiac and Pulmonary Vascular Hemodynamics in Patients With Heart Failure With Reduced Ejection Fraction. J Card Fail. 2023 Sep;29(9):1276-1284. doi: 10.1016/j.cardfail.2023.01.010. Epub 2023 Mar 5.
- Derived from this study: PubMed 33464953Sailer C, Edelmann H, Buchanan C, Giro P, Babcock M, Swanson C, Spotts M, Schulte M, Pratt-Cordova A, Coe G, Beindorff M, Page RL 2nd, Ambardekar AV, Pal JD, Kohrt W, Wolfel E, Lawley JS, Tarumi T, Cornwell WK 3rd. Impairments in Blood Pressure Regulation and Cardiac Baroreceptor Sensitivity Among Patients With Heart Failure Supported With Continuous-Flow Left Ventricular Assist Devices. Circ Heart Fail. 2021 Jan;14(1):e007448. doi: 10.1161/CIRCHEARTFAILURE.120.007448. Epub 2021 Jan 19.
- Individual participant dataSharing planned: No
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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.
William K Cornwell, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure，Congestive, run by University of Colorado, Denver 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 4 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 18 May 2023. 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. 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?
Results are not available in the source record.
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?
Changes in the sympathetic neural response. (time frame: 4 weeks prior to implantation and 6 months post implantation.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03078972, which also lists 3 linked publications.
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 18 May 2023.