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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01015144
Other study ID # 502-11-585
Secondary ID
Status Completed
Phase N/A
First received November 17, 2009
Last updated November 17, 2009
Start date February 2007
Est. completion date February 2009

Study information

Verified date November 2009
Source Medical Universtity of Lodz
Contact n/a
Is FDA regulated No
Health authority Poland: Ethics CommitteePoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Study type Observational

Clinical Trial Summary

The aim of the study was to assess of the influence of atorvastatin on selected indicators of an inflammatory condition, function of the left ventricle and factors affecting the occurrence of undesired events like rehospitalizations and mortality in patients with dilated cardiomyopathy.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date February 2009
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patients 18 years old or older

- patients who signed informed consent

- patients with dilated cardiomyopathy (according ESC 2007)

- patients who had no significant coronary artery stenoses >30% on cardiac catheterization

Exclusion Criteria:

- BP =140/90 lub <90/60

- congenital heart disease

- acquired valvular disease except for mitral incompetence secondary to left ventricular dilatation

- New York Heart Association (NYHA) functional class IV

- statin treatment

- preserved hyperactivity of aminotransferases with unexplained etiology,

- muscle disorders which might cause drug-induced myopathy,

- uncontrolled diabetes,

- liver diseases,

- creatinine level > 2 mg/dl and/or GFR<30ml/min,

- abuse of alcohol or drugs,

- chronic inflammatory diseases,

- pregnancy or lactation,

- severe hypothyroidism,

- immunosuppressive treatment,

- operation or severe injury during last month

- vaccination during last 3 months

- heart stimulation device or implantable cardioverter defibrillator

- or who didn't write conscious consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Drug:
Tulip
Patients were divided into two groups: A, who were administered atorvastatin 40 mg daily for two months and 10 mg for next 4 months; and group B, 4 who were treated according to current guidelines without statin therapy.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Medical Universtity of Lodz

References & Publications (2)

Bielecka-Dabrowa A, Wierzbicka M, Dabrowa M, Goch A. New methods in laboratory diagnostics of dilated cardiomyopathy. Cardiol J. 2008;15(4):388-95. Review. — View Citation

Bielecka-Dabrowa A, Wierzbicka M, Goch JH. [Proinflammatory cytokines in cardiovascular diseases as potential therapeutic target]. Wiad Lek. 2007;60(9-10):433-8. Review. Polish. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary left ventricular function 2 months No
Secondary mortality 6 months No
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