LV Diastolic Dysfunction Among the Patients With Systolic Heart Failure-clinical Significance and Prognostic Importance. (dd)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Meir Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01115764
First received: May 2, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted
  Purpose

Aims: To test the hypothesis that Diastolic dysfunction severity correlates with adverse clinical outcome in patients with systolic heart failure.


Condition
Heart Failure

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: LV Diastolic Dysfunction Among the Patients With Systolic Heart Failure

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • -Time to death from any cause or fist hospital admission for worsening HF, whichever occurs fist. [ Time Frame: 2 y ] [ Designated as safety issue: No ]
    Follow-up -2 y With out patients clinical evaluation monthly Exercise capacity evaluation every 3 mo Echocardiography one in half a year


Secondary Outcome Measures:
  • Change from baseline to month 6 : in KCCQ Overall Summary Score [ Time Frame: 6 mo ] [ Designated as safety issue: No ]

    Change from baseline to month 6 :

    in KCCQ Overall Summary Score

    in KCCQ Symptom Frequency Score.

    of EQ-5D

    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.



Estimated Enrollment: 200
Study Start Date: May 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Detailed Description:

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:

  1. Maximal work capacity testing (in METS) per BRUCE protocol,
  2. HR response estimation,
  3. 6-min walk test (to walk down 100 foot corridor to cover as much as possible in 6min)
  4. 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
  5. 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Study population

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.

Criteria

Summary of Subject Eligibility criteria:

  • Men and women >18 years of age.
  • HF of> 3 mo duration and NYHA class II, III, or IV at time of randomization.
  • LVEF <45%
  • Blood pressure <160/100
  • No HF primarily due to valvular heart disease and no clinically significant valvular heart disease that might lead to surgical correction within 12 months of randomization.
  • No implantable ICD or CRT within 30 days prior to randomization.
  • No chemo- or radio-therapy for treatment of a malignancy within 6 months prior to randomization or clinical evidence of current malignancy with the following exception: local BCC of the skin or cervical intraepithelial neoplasia.
  • Serum creatinine<2.5 mg/dl
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01115764

Contacts
Contact: Korotinsky Svetlana, doctor 03-6313870 sv_korot@walla.co.il

Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Korotinsky Svetlana, doctor Israel: Clalit Health Services
  More Information

No publications provided

Responsible Party: MeirMc, Israel, : Helsinki Committee, MeirMc, Israel
ClinicalTrials.gov Identifier: NCT01115764     History of Changes
Other Study ID Numbers: MMC10023/2010kCTIL
Study First Received: May 2, 2010
Last Updated: May 2, 2010
Health Authority: Israel: Clalit Health Services

Keywords provided by Meir Medical Center:
diastolic dysfunction

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014