Clinical trial NCT00998205: Early Diagnosis of Diastolic Dysfunction and Reliability of DSE in Detecting Stress Diastolic Dysfunction
Official title: Early Diagnosis of Diastolic Dysfunction and Reliability of Dobutamine Stress Echo (DSE) in Detecting Stress Diastolic Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diastolic Dysfunction
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: Kansas City Veteran Affairs Medical Center
First posted: 2009-10-20
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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 Advanced Cardiac Life Support (ACLS) certified nurses and doctors.

Eligibility criteria: Inclusion Criteria:

* Prospectively enroll 25 veterans age range from 18 to 65 who are found to have normal left ventricular (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.

Primary outcomes:
measure: Change in Left Ventricle Mean Diastolic Pressure
timeFrame: Baseline, recovery
Secondary outcomes:
measure: Change in Early Transmitral Velocity/Early Lateral Mitral Velocity (E/E')
timeFrame: Baseline, recovery
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
affiliation: University of Missouri/Harry S Truman VA Hospital
name: Anand Chockalingam, MD
role: PRINCIPAL_INVESTIGATOR
References: