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
  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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Nancy K. Sweitzer MD, PhD, University of Wisconsin
ClinicalTrials.gov Identifier: NCT00585806     History of Changes
Other Study ID Numbers: HSC# 2005-0408, UW grant:133 ET18 A53 4225
Study First Received: December 26, 2007
Last Updated: February 3, 2010
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014