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The effect of spironolactone in treatment of heart failure

The effect of spironolactone on the clinical characteristics, laboratory, and echocardiography in patients with heart failure Preserved EF

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015101924597N1
Enrollment
60
Registered
2016-01-29
Start date
2015-08-23
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure. Congestive heart failure

Interventions

Intervention 1: In the intervention group spironolactone tablets (tablets 25 mg pharmaceutical company Mino) at a dose of 12.5 mg daily after two weeks if there is no increase in creatinine and potass
Treatment - Drugs
In the intervention group spironolactone tablets (tablets 25 mg pharmaceutical company Mino) at a dose of 12.5 mg daily after two weeks if there is no increase in creatinine and potassium is increased
In the control group of spironolactone tablets that are quite similar to a placebo drug company is prepared

Sponsors

Vice chancellor for research of Iran university of medical sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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 5.5 mEq/L.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
NT-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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Saeid Soltaniomid

Iran University of Medical Sciences

dr.sso48@gmail.com+98 21665160072450

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026