N/A
Completed N=16
Early Diagnosis of Diastolic Dysfunction and Reliability of DSE in Detecting Stress Diastolic Dysfunction
Diastolic Dysfunction
Source: ClinicalTrials.gov NCT00998205 ↗
Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcomePrimary: Change in Left Ventricle Mean Diastolic Pressure — 3.3 mmHg
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Left Ventricle Mean Diastolic Pressure |
3.3 | — |
| SECONDARY Change in Early Transmitral Velocity/Early Lateral Mitral Velocity (E/E') |
0.4; -0.4 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00998205). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.