LV Diastolic Dysfunction Among the Patients With Systolic Heart Failure-clinical Significance and Prognostic Importance. (dd)
|ClinicalTrials.gov Identifier: NCT01115764|
Recruitment Status : Unknown
Verified May 2010 by Meir Medical Center.
Recruitment status was: Not yet recruiting
First Posted : May 4, 2010
Last Update Posted : May 4, 2010
|Condition or disease|
Recent studies have explored the prognostic role of TDI-derived parameters in major cardiac diseases, such as heart failure, acute myocardial infarction, and hypertension.(1-3). In these conditions, myocardial mitral annular or basal segmental (Sm) systolic and early diastolic (Ea or Em) velocities have been shown to predict mortality or cardiovascular events. In particular, those with reduced Sm or Em values of <3 cm/s have a very poor prognosis. In heart failure and after myocardial infarction, noninvasive assessment of LV diastolic pressure by transmitral to mitral annular early diastolic velocity ratio (E/Ea or E/Em) is a strong prognosticator, especially when E/Ea is > or =15. (3) Conventional Doppler indices and TDI parameters correlated with functional class in patients with advanced heart failure. The E/E' ratio, which probably reflects high LV end-diastolic pressure, was the best measure for differentiating patients with functional class III and IV, and it also correlated with cardiac mortality and hospitalization for worsening heart failure, thereby providing additional value to standard echocardiographic measures(4-5) In our study we'll try to demonstrate that clinical deterioration of patients with LV systolic dysfunction directly correlates with parameters of their diastolic function and that these parameters more predictable than changes in LVEF.
This study will be performed on the base of Natania Heart Institute (out of hospital clinic).
Within community-based population study we'll select the patients with LV systolic dysfunction.
The participants will be classified according to their LV systolic function, functional class (NYHA) of HF.
Approximately 200 subjects will be enrolled.
The participants will be evaluate according their baseline features, clinical status using EQ-5D score, KCCQ Overall Summary Score, KCCQ Symptom Frequency Score.
After enrolment all our patients will undergo:
- Maximal work capacity testing (in METS) per BRUCE protocol,
- HR response estimation,
- 6-min walk test (to walk down 100 foot corridor to cover as much as possible in 6min)
- VO2 estimation using the knowing formula VO2 (mlO2/kg/min) = (mphX2.68)+(1.8X26.82XmphXgrade+100)+3.5 1MET =3.5 ml Q2/kg/min
- Echocardiography will be performed by VIVID -7 with 3.7 MHz probe All subjects examined with color TDI, FPV, two-dimensional and M-mode echo in the left lateral decubitus position.
Follow-up Follow-up at least 2 years With out patients clinical evaluation monthly Exercise capacity evaluation every 3 mo Echocardiography one in half a year
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||LV Diastolic Dysfunction Among the Patients With Systolic Heart Failure|
|Study Start Date :||May 2010|
|Estimated Primary Completion Date :||May 2012|
|Estimated Study Completion Date :||June 2012|
- -Time to death from any cause or fist hospital admission for worsening HF, whichever occurs fist. [ Time Frame: 2 y ]Follow-up -2 y With out patients clinical evaluation monthly Exercise capacity evaluation every 3 mo Echocardiography one in half a year
- Change from baseline to month 6 : in KCCQ Overall Summary Score [ Time Frame: 6 mo ]
Change from baseline to month 6 :
in KCCQ Overall Summary Score
in KCCQ Symptom Frequency Score.
in NYHA class of each time- point.
in maximal work capacity
in 6-min walk test
Change in VO2
Total number of hospital admission for worsening HF
Total duration of hospital admission for worsening HF
Total number of hospital admission for non-fatal c-v event, resuscitated sudden death, arrhythmia, new onset atrial fibrillation.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01115764
|Contact: Korotinsky Svetlana, email@example.com|
|Principal Investigator:||Korotinsky Svetlana, doctor||Israel: Clalit Health Services|