NCT00984529

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2009

Shorter than P25 for all trials

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 25, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

January 7, 2011

Status Verified

January 1, 2011

Enrollment Period

5 months

First QC Date

September 24, 2009

Last Update Submit

January 6, 2011

Conditions

Keywords

Chronic heart failurecandesartan cilexetilclinical signssymptoms

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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)

Study Arms (1)

1

Cardiologist´s office patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary Care

You may qualify if:

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

You may not qualify if:

  • Hypersensitivity to candesartan cilexetil
  • Pregnancy / lactation
  • Severe hepatic impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Research Site

Biograd na Moru, Croatia

Location

Research Site

Bjelovar, Croatia

Location

Reserach Site

Čakovec, Croatia

Location

Research Site

Karlovac, Croatia

Location

Reserach Site

Krapinske Toplice, Croatia

Location

Research Site

Novi Marof, Croatia

Location

Research Site

Opatija, Croatia

Location

Research Site

Osijek, Croatia

Location

Research Site

Pula, Croatia

Location

Research Site

Rijeka, Croatia

Location

Reserach Site

Sl. Brod, Croatia

Location

Research Site

Split, Croatia

Location

Research Site

Stubičke Toplice, Croatia

Location

Reserach Site

Zabok, Croatia

Location

Research Site

Zagreb, Croatia

Location

MeSH Terms

Conditions

Signs and Symptoms

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 24, 2009

First Posted

September 25, 2009

Study Start

September 1, 2009

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

January 7, 2011

Record last verified: 2011-01

Locations