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

October 19, 2009
June 15, 2011
June 2008
January 2011   (final data collection date for primary outcome measure)
Evaluate the reliability of DSE in tracking diastolic function, i.e., filling pressures. [ Time Frame: 15-20 minutes ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00998205 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Early Diagnosis of Diastolic Dysfunction and Reliability of Dobutamine Stress Echo (DSE) in Detecting Stress Diastolic Dysfunction
Early Diagnosis of Diastolic Dysfunction and Reliability of DSE in Detecting Stress Diastolic Dysfunction

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Diastolic Dysfunction
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.
Dobutamine stress echo (DSE)
Intervention: Drug: Dobutamine stress echo (DSE)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
January 2011
January 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00998205
1115797
No
Anand Chockalingam, MD, Assistant Professor of Clinical Medicine, University of Missouri
University of Missouri-Columbia
Not Provided
Principal Investigator: Anand Chockalingam, MD University of Missouri/Harry S Truman VA Hospital
University of Missouri-Columbia
June 2011

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