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

This study has been completed.
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00585806
First received: December 26, 2007
Last updated: February 3, 2010
Last verified: February 2010

December 26, 2007
February 3, 2010
December 2005
June 2009   (final data collection date for 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00585806 on ClinicalTrials.gov Archive Site
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Assessment of Cardiac Functional Reserve in Heart Failure With Preserved Ejection Fraction (HF-PEF)
Assessment of Cardiac Functional Reserve in Heart Failure With Preserved Ejection Fraction (HF-PEF)

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

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.

Heart Failure
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  • 1
    Subjects with Heart Failure and ejection fraction greater than or equal to 45%
  • 2
    Healthy Volunteers
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
June 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00585806
HSC# 2005-0408, UW grant:133 ET18 A53 4225
No
Nancy K. Sweitzer MD, PhD, University of Wisconsin
University of Wisconsin, Madison
Not Provided
Principal Investigator: Nancy K Sweitzer, MD, PhD University of Wisconsin, Madison
University of Wisconsin, Madison
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP