The effect of spironolactone in treatment of heart failure
Phase 2
- Conditions
- Heart Failure.Congestive heart failure
- Registration Number
- IRCT2015101924597N1
- Lead Sponsor
- Vice chancellor for research of Iran university of medical sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Patients have a clear history of heart failure, according to Framingham criteria (the two major criteria or a major criteria and two minor criteria); Transthoracic Echocardiography with an Ejection Fraction(EF) more than or equal to 45%; and based on the criteria in the class New York Heart Association(NYHA) III and IV and have need to admition in Intesive Care Unit(ICU). Exclusion criteria: serum creatinine > 2.5 mgr/dlit in males and > 2 mgr/dlit in females or GFR < 30ml/min/1.73 m2; serum potassium> 5.5 mEq/L.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method T-proBNP. Timepoint: At the time of admission, 72 hours of hospitalization, at discharge, one month and three months after discharge. Method of measurement: whole blood and FIA8000 Quantitative Immunoassay.;Transthorasic ECHO: LA size? grade(DD)? E/E'? E/A? PAP? RV size? MR(%)? decleration time? Tapse? EF. Timepoint: At the time of admission , one month and three months after discharge. Method of measurement: ECHO.;Heart functional class. Timepoint: At the time of admission, one month and three months after discharge. Method of measurement: NYHA.;Laboratory parameters. Timepoint: At the time of admission, 72 hours of hospitalization, at discharge, one month and three months after discharge. Method of measurement: Creat. Hb. Tn. Na. U.A.
- Secondary Outcome Measures
Name Time Method The side effects of spironolactone. Timepoint: During treatment with spironolactone. Method of measurement: questionnaire.;APACHE II. Timepoint: In the first 24 hours of admission. Method of measurement: APACHE II score.;Length of stay in ICU. Timepoint: Length of stay in hospital. Method of measurement: The number of days of hospitalization in ICU.