Assessment of Cardiac Functional Reserve in Heart Failure With Preserved Ejection Fraction (HF-PEF)
DobStress
2 other identifiers
observational
19
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2005
Typical duration for all trials
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
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 26, 2007
CompletedFirst Posted
Study publicly available on registry
January 3, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedOctober 5, 2015
February 1, 2010
3.5 years
December 26, 2007
October 1, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
throughout study
Study Arms (2)
1
Subjects with Heart Failure and ejection fraction greater than or equal to 45%
2
Healthy Volunteers
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nancy K Sweitzer, MD, PhD
University of Wisconsin, Madison
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 26, 2007
First Posted
January 3, 2008
Study Start
December 1, 2005
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
October 5, 2015
Record last verified: 2010-02