Assessment of Cardiac Functional Reserve in Heart Failure With Preserved Ejection Fraction (HF-PEF)
Status: | Completed |
---|---|
Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | December 2005 |
End Date: | June 2009 |
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.
during stress in patients with a history of heart failure without systolic dysfunction and
in controls.
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
We found this trial at
1
site
600 Highland Ave
Madison, Wisconsin 53792
Madison, Wisconsin 53792
(608) 263-6400
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