Early Diagnosis of Diastolic Dysfunction and Reliability of Dobutamine Stress Echo (DSE) in Detecting Stress Diastolic Dysfunction

This study has been completed.
Sponsor:
Information provided by:
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00998205
First received: October 19, 2009
Last updated: June 15, 2011
Last verified: June 2011
  Purpose

The heart becoming "stiff" due to increased fibrous tissue or decreased elasticity of the heart tissue is one of the earliest changes caused by heart failure. These changes can be detected by simple non-invasive echocardiogram techniques. However, these techniques usually detect the increased "stiffness" of the heart only after it has progressed to a significant extent. The investigators hypothesize that if they stress the heart using a Dobutamine infusion and measure the filling pressure using echocardiogram, it will provide them with tools to identify these changes earlier.

The investigators are planning to include people have normal heart function. It is standard procedure to measure cardiac pressure during catheterization. Simultaneously, the investigators will infuse Dobutamine (standard drug used for chemical stress testing, DSE). This drug increases the heart rate and mimics exercise in normal humans who are unable to exercise for various reasons. The investigators would continue to monitor the pressure inside the heart as they infuse Dobutamine and see of there is an increase in filling pressure. The investigators will correlate the invasive pressures with their echo derived measurements.

The investigators plan to include 25 veterans in this study. For each individual the study would increase the amount of time they will spend in the Catheterization Lab from 30 to 120 minutes. The entire procedure will be monitored by ACLS certified nurses and doctors.


Condition Intervention
Diastolic Dysfunction
Drug: Dobutamine stress echo (DSE)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Early Diagnosis of Diastolic Dysfunction and Reliability of DSE in Detecting Stress Diastolic Dysfunction

Resource links provided by NLM:


Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • Evaluate the reliability of DSE in tracking diastolic function, i.e., filling pressures. [ Time Frame: 15-20 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measure E/E' at rest and with dobutamine stress with a target heart rate of at least 85% of age predicted maximal heart rate. [ Time Frame: 15-20 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: June 2008
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Dobutamine stress echo (DSE) Drug: Dobutamine stress echo (DSE)
Dobutamine intravenous infusion would be undertaken starting at 10 micrograms/kg per minute in three minute intervals increased to 20, 30, 40 or 50 micrograms/kg per minute or to a peak heart rate response of at least 85% age predicted maximum heart rate. If at the end of the Dobutamine protocol, there is inadequate heart rate response, intravenous atropine boluses of 0.5 milligrams (maximum 1.0 mg) would be used as needed to achieve a heart rate of at least 85% of age predicted maximum heart rate.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Prospectively enroll 25 veterans age range from 18 to 65 who are found to have normal LV systolic function and no significant coronary artery disease by cardiac catheterization.
  • Subjects identified during routine cardiac testing to have significant diastolic dysfunction may also be enrolled to rule out coronary disease and study DSE -invasive pressure correlations.

Exclusion criteria:

  • Patients with LV systolic dysfunction, severe coronary lesions (> 50%), uncontrolled hypertension (BP > 160/100) and significant pulmonary hypertension (PASP > 50 mmHg) would be excluded.
  • Subject will not be included if they have a significant rhythm abnormality, frequent premature ventricular complexes, atrial fibrillation and technical reasons in the catheterization laboratory which preclude the study protocol.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00998205

Locations
United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Anand Chockalingam, MD University of Missouri/Harry S Truman VA Hospital
  More Information

No publications provided

Responsible Party: Anand Chockalingam, MD, Assistant Professor of Clinical Medicine, University of Missouri
ClinicalTrials.gov Identifier: NCT00998205     History of Changes
Other Study ID Numbers: 1115797
Study First Received: October 19, 2009
Last Updated: June 15, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dobutamine
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on September 16, 2014