Chronic Heart FailureNCT00984529
Evaluation of Clinical Signs and Symptoms of Chronic Heart Failure in Patients Treated With Candesartan Cilexetil in Croatia
An observational study of Chronic Heart Failure, run by AstraZeneca at 15 sites in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure
- How many people
- 500 participants
- Where
- 15 sitesCroatia
- Study dates
- Sep 2009to Feb 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary Care
Who may be able to join
- Patients with diagnosed chronic heart failure
- Patients treated for at least 6 months with candesartan cilexetil
- Signed Informed consent
Who cannot join
- Hypersensitivity to candesartan cilexetil
- Pregnancy / lactation
- Severe hepatic impairment
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Croatia15 sites
Research Site
Biograd na Moru
Research Site
Bjelovar
Reserach Site
Čakovec
Research Site
Karlovac
Reserach Site
Krapinske Toplice
Research Site
Novi Marof
Research Site
Opatija
Research Site
Osijek
Research Site
Pula
Research Site
Rijeka
Reserach Site
Sl. Brod
Research Site
Split
Research Site
Stubičke Toplice
Reserach Site
Zabok
Research Site
Zagreb
About this study
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.
- Conditions
- Chronic Heart Failure
- Keywords
- Chronic heart failure, candesartan cilexetil, clinical signs, symptoms
- Medical subject headings
- Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Cardiologist´s office patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 1 visit (after at least 6 months of treatment)
To evaluate patient's compliance with prescribed treatment
Measured: 1 visit (after at least 6 months of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00984529
- Sponsor's protocol ID
- NIS-CHR-ATA-2008/1
- Status last verified
- Jan 2011
- First submitted
- 24 Sep 2009
- Last updated
- 7 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Signs and Symptoms of Chronic Heart Failure in Patients Treated With Candesartan Cilexetil in Croatia
- ClinicalTrials.gov ID
- NCT00984529
- Acronym / sponsor ID
- NIS-CHR-ATA-2008/1
- Conditions
- Chronic Heart Failure
- Keywords
- Chronic heart failure, candesartan cilexetil, clinical signs, symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 25 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Cardiologist´s office patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Care
Key inclusion criteria (3 listed)
- Patients with diagnosed chronic heart failure
- Patients treated for at least 6 months with candesartan cilexetil
- Signed Informed consent
Key exclusion criteria (3 listed)
- Hypersensitivity to candesartan cilexetil
- Pregnancy / lactation
- Severe hepatic impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
3 secondary outcomes
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)
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)
To evaluate patient's compliance with prescribed treatment
Time frame: 1 visit (after at least 6 months of treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Heart Failure, run by AstraZeneca at 15 sites in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2011.