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Early Diagnosis of Diastolic Dysfunction and Reliability of DSE in Detecting Stress Diastolic Dysfunction

This study has been completed.
Sponsor:
Collaborator:
Veterans Administration, Kansas City
Information provided by (Responsible Party):
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00998205
First received: October 19, 2009
Last updated: April 3, 2017
Last verified: April 2017
Results First Received: November 21, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Diastolic Dysfunction
Interventions: Drug: Dobutamine stress echo (DSE)
Drug: Atropine bolus

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Dobutamine Stress Echo (DSE) Dobutamine intravenous infusion 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.

Participant Flow:   Overall Study
    Dobutamine Stress Echo (DSE)
STARTED   16 
COMPLETED   16 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Dobutamine Stress Echo (DSE) Dobutamine intravenous infusion 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.

Baseline Measures
   Dobutamine Stress Echo (DSE) 
Overall Participants Analyzed 
[Units: Participants]
 16 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      16 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      1   6.3% 
Male      15  93.8% 
Region of Enrollment 
[Units: Participants]
 
United States   16 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Left Ventricle Mean Diastolic Pressure   [ Time Frame: Baseline, recovery ]

2.  Secondary:   Change in Early Transmitral Velocity/Early Lateral Mitral Velocity (E/E')   [ Time Frame: Baseline, recovery ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Anand Chockalingam
Organization: University of Missouri-Columbia
phone: 573-882-2296
e-mail: chockalingama@missouri.edu



Responsible Party: University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT00998205     History of Changes
Other Study ID Numbers: 1115797
Study First Received: October 19, 2009
Results First Received: November 21, 2016
Last Updated: April 3, 2017