Heart FailureDobStressNCT00585806
Assessment of Cardiac Functional Reserve in Heart Failure With Preserved Ejection Fraction (HF-PEF)
An observational study of Heart Failure, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This study will compare the ability of the heart to increase its contractile performance during stress in patients with a history of heart failure without systolic dysfunction and in controls. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Jun 2009
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Potential subjects will be identified from the heart failure population scheduled for visits to the heart failure clinic, use of the GIM Funneling Project and the University of Wisconsin Institute on Aging.
Who may be able to join
- mentally stable and willing to give informed consent
- sinus rhythm on resting ECG
- systolic blood pressure > 90 mmHg
- ejection fraction > 45% assessed within the last year
- stable heart failure for at least one month prior to study
Who cannot join
- unstable angina or hemodynamic instability
- known severe coronary artery disease without surgical or percutaneous revascularization
- angina pectoris with usual activities
- history of myocardial infarction in the previous six months, significant valvular abnormalities, pulmonary hypertension, COPD or pulmonary emboli, intracardiac thrombus, sustained ventricular tachycardia induced by dobutamine in the past, or known allergy or other intolerance to dobutamine
- uncontrolled hypertension
- pregnant women
- permanent pacemaker with pacemaker dependency
- known poor echocardiographic images
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
About this study
This study will compare the ability of the heart to increase its contractile performance during stress in patients with a history of heart failure without systolic dysfunction and in controls.
Read the detailed description
There will be two groups of 20 subjects recruited in a collaborative effort by UWHC and University of Pennsylvania. This project will require one visit approximately 3-5 hours in length. The subject will fill out a symptom questionnaire. A small gauge angiocath will be place to establish intravenous access. Single-lead ECG and blood pressure are monitored for the duration of the protocol. Tonometry (non-invasive measurement of the pulse) and echocardiographic images will be obtained at baseline. After baseline data are obtained, dobutamine will be infused at escalating doses of 2, 4, 8, and 16 µg/kg/min IV at ≤30-minute intervals. After 5 minutes of infusion at each dose, echocardiographic and tonometry data will be recorded. If 85% or more of predicted target heart rate is reached, the final study data collection and safety imaging will be performed and the dose not increased further.
- Conditions
- Heart Failure
- Keywords
- Heart Failure with preserved ejection fraction
- 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 |
|---|---|---|
| 1 | Subjects with Heart Failure and ejection fraction greater than or equal to 45% | |
| 2 | Healthy Volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the peak increase in modified preload-adjusted maximal power during DSE using non-invasive tonometry estimates of central aortic pressure, and echocardiographic assessment of proximal aorta flow
Measured: throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2008 (estimated)
- Study startDec 2005
- Primary completionJun 2009
- Study completionJun 2009
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 University of Wisconsin, MadisonThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nancy K Sweitzer, MD, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00585806
- Sponsor's protocol ID
- HSC# 2005-0408
- Other IDs
- UW grant:133 ET18 A53 4225
- Acronym
- DobStress
- Status last verified
- Feb 2010
- First submitted
- 26 Dec 2007
- Last updated
- 5 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cardiac Functional Reserve in Heart Failure With Preserved Ejection Fraction (HF-PEF)
- ClinicalTrials.gov ID
- NCT00585806
- Acronym / sponsor ID
- DobStress / HSC# 2005-0408
- Conditions
- Heart Failure
- Keywords
- Heart Failure with preserved ejection fraction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 3 Jan 2008 (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 will compare the ability of the heart to increase its contractile performance during stress in patients with a history of heart failure without systolic dysfunction and in controls.
Detailed description
There will be two groups of 20 subjects recruited in a collaborative effort by UWHC and University of Pennsylvania. This project will require one visit approximately 3-5 hours in length. The subject will fill out a symptom questionnaire. A small gauge angiocath will be place to establish intravenous access. Single-lead ECG and blood pressure are monitored for the duration of the protocol. Tonometry (non-invasive measurement of the pulse) and echocardiographic images will be obtained at baseline. After baseline data are obtained, dobutamine will be infused at escalating doses of 2, 4, 8, and 16 µg/kg/min IV at ≤30-minute intervals. After 5 minutes of infusion at each dose, echocardiographic and tonometry data will be recorded. If 85% or more of predicted target heart rate is reached, the final study data collection and safety imaging will be performed and the dose not increased further.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Subjects with Heart Failure and ejection fraction greater than or equal to 45% |
| 2 | – | –Healthy Volunteers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Potential subjects will be identified from the heart failure population scheduled for visits to the heart failure clinic, use of the GIM Funneling Project and the University of Wisconsin Institute on Aging.
Key inclusion criteria (5 listed)
- mentally stable and willing to give informed consent
- sinus rhythm on resting ECG
- systolic blood pressure > 90 mmHg
- ejection fraction > 45% assessed within the last year
- stable heart failure for at least one month prior to study
Key exclusion criteria (8 listed)
- unstable angina or hemodynamic instability
- known severe coronary artery disease without surgical or percutaneous revascularization
- angina pectoris with usual activities
- history of myocardial infarction in the previous six months, significant valvular abnormalities, pulmonary hypertension, COPD or pulmonary emboli, intracardiac thrombus, sustained ventricular tachycardia induced by dobutamine in the past, or known allergy or other intolerance to dobutamine
- uncontrolled hypertension
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
The primary endpoint is the peak increase in modified preload-adjusted maximal power during DSE using non-invasive tonometry estimates of central aortic pressure, and echocardiographic assessment of proximal aorta flow
Time frame: throughout study
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 5 Oct 2015.
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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.
Nancy K Sweitzer, MD, PhD principal investigator
University of Wisconsin, Madison
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, run by University of Wisconsin, Madison 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 5 inclusion and 8 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 5 Oct 2015. 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?
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?
The primary endpoint is the peak increase in modified preload-adjusted maximal power during DSE using non-invasive tonometry estimates of central aortic pressure, and echocardiographic assessment of proximal aorta flow (time frame: throughout study). 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 5 Oct 2015.