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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00984529
First received: September 24, 2009
Last updated: January 6, 2011
Last verified: January 2011
  Purpose

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
Chronic Heart Failure

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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 [ Time Frame: 1 visit (after at least 6 months of treatment) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate ventricular function after at least 6 months of treatment with candesartan cilexetil [ Time Frame: 1 visit (after at least 6 months of treatment) ] [ Designated as safety issue: No ]
  • To gain insight into usage of candesartan cilexetil in real life for chronic heart failure in Croatia [ Time Frame: 1 visit (after at least 6 months of treatment) ] [ Designated as safety issue: No ]
  • To evaluate patient`s compliance with prescribed treatment [ Time Frame: 1 visit (after at least 6 months of treatment) ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: September 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Cardiologist´s office patients

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary Care

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00984529

Locations
Croatia
Research Site
Biograd, Croatia
Research Site
Bjelovar, Croatia
Reserach Site
Cakovec, Croatia
Research Site
Karlovac, Croatia
Reserach Site
Krapinske Toplice, Croatia
Research Site
Novi Marof, Croatia
Research Site
Opatija, Croatia
Research Site
Osijek, Croatia
Research Site
Pula, Croatia
Research Site
Rijeka, Croatia
Reserach Site
Sl. Brod, Croatia
Research Site
Split, Croatia
Research Site
Stubicke Toplice, Croatia
Reserach Site
Zabok, Croatia
Research Site
Zagreb, Croatia
Sponsors and Collaborators
AstraZeneca
  More Information

No publications provided

Responsible Party: MCMD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00984529     History of Changes
Other Study ID Numbers: NIS-CHR-ATA-2008/1
Study First Received: September 24, 2009
Last Updated: January 6, 2011
Health Authority: Croatia: Ethics Committee
Croatia: Ministry of Health and Social Care

Keywords provided by AstraZeneca:
Chronic heart failure
candesartan cilexetil
clinical signs
symptoms

Additional relevant MeSH terms:
Heart Failure
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases
Candesartan cilexetil
Candesartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014