Evaluation of Clinical Signs and Symptoms of Chronic Heart Failure in Patients Treated With Candesartan Cilexetil in Croatia

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00984529

Collaborator

(none)

500

Enrollment

Locations

Duration (Months)

33.3

Patients Per Site

6.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether treatment with candesartan cilexetil for at least 6 months in patients with chronic heart failure improves clinical signs and symptoms of chronic heart failure.

Condition or Disease	Intervention/Treatment	Phase
Chronic Heart Failure

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Evaluation of Clinical Signs and Symptoms of Chronic Heart Failure in Patients Treated With Candesartan Cilexetil in Croatia

Study Start Date :

Sep 1, 2009

Actual Primary Completion Date :

Feb 1, 2010

Actual Study Completion Date :

Feb 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
1 Cardiologist´s office patients

Outcome Measures

Primary Outcome Measures

To evaluate clinical signs and symptoms of chronic heart failure (in terms of NYHA status, fluid retention and tiredness/fatigue) after at least 6 months of treatment with candesartan cilexetil [1 visit (after at least 6 months of treatment)]

Secondary Outcome Measures

To evaluate ventricular function after at least 6 months of treatment with candesartan cilexetil [1 visit (after at least 6 months of treatment)]
To gain insight into usage of candesartan cilexetil in real life for chronic heart failure in Croatia [1 visit (after at least 6 months of treatment)]
To evaluate patient's compliance with prescribed treatment [1 visit (after at least 6 months of treatment)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with diagnosed chronic heart failure
Patients treated for at least 6 months with candesartan cilexetil
Signed Informed consent

Exclusion Criteria:

Hypersensitivity to candesartan cilexetil
Pregnancy / lactation
Severe hepatic impairment

Contacts and Locations

Locations

	Site	City	Country
1	Research Site	Biograd	Croatia
2	Research Site	Bjelovar	Croatia
3	Reserach Site	Cakovec	Croatia
4	Research Site	Karlovac	Croatia
5	Reserach Site	Krapinske Toplice	Croatia
6	Research Site	Novi Marof	Croatia
7	Research Site	Opatija	Croatia
8	Research Site	Osijek	Croatia
9	Research Site	Pula	Croatia
10	Research Site	Rijeka	Croatia
11	Reserach Site	Sl. Brod	Croatia
12	Research Site	Split	Croatia
13	Research Site	Stubicke Toplice	Croatia
14	Reserach Site	Zabok	Croatia
15	Research Site	Zagreb	Croatia