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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00585806
First Posted: January 3, 2008
Last Update Posted: October 5, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Wisconsin, Madison
  Purpose
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.

Condition
Heart Failure

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Assessment of Cardiac Functional Reserve in Heart Failure With Preserved Ejection Fraction (HF-PEF)

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • 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 ]

Enrollment: 19
Study Start Date: December 2005
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Subjects with Heart Failure and ejection fraction greater than or equal to 45%
2
Healthy Volunteers

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00585806


Locations
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Nancy K Sweitzer, MD, PhD University of Wisconsin, Madison
  More Information

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00585806     History of Changes
Other Study ID Numbers: HSC# 2005-0408
UW grant:133 ET18 A53 4225
First Submitted: December 26, 2007
First Posted: January 3, 2008
Last Update Posted: October 5, 2015
Last Verified: February 2010

Keywords provided by University of Wisconsin, Madison:
Heart Failure with preserved ejection fraction

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases