Heart Failure Clinical Trial

Assessment of Cardiac Functional Reserve in Heart Failure With Preserved Ejection Fraction (HF-PEF)

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.

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Full 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.

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Eligibility Criteria

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

Study is for people with:

Heart Failure

Estimated Enrollment:

19

Study ID:

NCT00585806

Recruitment Status:

Completed

Sponsor:

University of Wisconsin, Madison

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There is 1 Location for this study

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University of Wisconsin Hospital and Clinics
Madison Wisconsin, 53792, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

19

Study ID:

NCT00585806

Recruitment Status:

Completed

Sponsor:


University of Wisconsin, Madison

How clear is this clinincal trial information?

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