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

NCT01115764 | Unknown DMC

• 1 other identifier: MMC10023/2010kCTIL
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Heart Failure

Keywords

diastolic dysfunction

Outcome Measures

Primary Outcomes (1)

• -Time to death from any cause or fist hospital admission for worsening HF, whichever occurs fist.

  Follow-up -2 y With out patients clinical evaluation monthly Exercise capacity evaluation every 3 mo Echocardiography one in half a year

  2 y

Secondary Outcomes (1)

• Change from baseline to month 6 : in KCCQ Overall Summary Score

  6 mo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Meir Medical Center: lead

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Korotinsky Svetlana, doctor

  Israel: Clalit Health Services

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Korotinsky Svetlana, doctor

CONTACT

03-6313870; sv_korot@walla.co.il

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 2, 2010
• First Posted: May 4, 2010
• Study Start: May 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: June 1, 2012
• Last Updated: May 4, 2010

Record last verified: 2010-05