Chronic Heart FailureALERT-HFNCT01813331
ALERT-HF: Adherence to Guidelines in the Treatment of Patients With Chronic Heart Failure
An observational study of Chronic Heart Failure, run by Federico II University at 1 site in Italy.
Trial summary
ALERT-HF is an observational study aimed to evaluate the diagnostic criteria adopted and the adherence to the current therapeutic guidelines in a large series of patients affected with chronic heart failure. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Chronic Heart Failure
- How many people
- 660 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2012to Feb 2013
- How long will I take part?
- 3 Months
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Chronic Heart Failure patients older than 65 years, consecutively referred to the A.R.C.A Campania Cardiologists in the pertaining healthcare districts
Who may be able to join
- Diagnosis of Heart Failure
- Signature of informed consent
- Age older than 65 years
Who cannot join
- indication for cardiac surgery or cardiac surgery by less than 3 months
- age less than 65 years
- inability to perform periodic checks
- presence of malignant neoplasms and other severe diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ALERT-HF:Adherence to Guidelines in the Treatment of Patients With Chronic Heart Failure
ALERT-HF is an observational study aimed to evaluate the diagnostic criteria adopted and the adherence to the current therapeutic guidelines in a large series of patients affected with chronic heart failure. Secondary objective is to evaluate the prevalence of chronic heart failure among all the patients referring to the ambulatory cardiologists of the healthcare district.
- Conditions
- Chronic Heart Failure
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 |
|---|---|---|
| Chronic Heart Failure Patients | Chronic Heart Failure patients older than 65 years, which accept to participate to the study and give their informed written consent and consecutively refer to the A.R.C.A Campania Cardiologists in the pertaining healthcare districts. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients treated with each of the following indicators of adherence to the current therapeutic guidelines:-ACEI -ARB -beta blockers -loop diuretics -aldosterone antagonists -digoxin -anticoagulant therapy - implantation of cardiac devices
Measured: first physical examination and clinical evaluation performed during a 3 months period, from November 2012 to January 2013
Secondary outcomes (1)
evaluate the prevalence of chronic heart failure among all the patients referring to the ambulatory cardiologists of the healthcare district
Measured: first evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2013 (estimated)
- Study startNov 2012
- Primary completionJan 2013
- Study completionFeb 2013
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 Federico II UniversityThe 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 660 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oliviero Ugo, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01813331
- Sponsor's protocol ID
- 161/12
- Acronym
- ALERT-HF
- Status last verified
- Mar 2013
- First submitted
- 7 Mar 2013
- Last updated
- 18 Mar 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ALERT-HF:Adherence to Guidelines in the Treatment of Patients With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT01813331
- Acronym / sponsor ID
- ALERT-HF / 161/12
- Conditions
- Chronic Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 660 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 18 Mar 2013 (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.
ALERT-HF is an observational study aimed to evaluate the diagnostic criteria adopted and the adherence to the current therapeutic guidelines in a large series of patients affected with chronic heart failure. Secondary objective is to evaluate the prevalence of chronic heart failure among all the patients referring to the ambulatory cardiologists of the healthcare district.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Heart Failure Patients | – | –Chronic Heart Failure patients older than 65 years, which accept to participate to the study and give their informed written consent and consecutively refer to the A.R.C.A Campania Cardiologists in the pertaining healthcare districts. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Chronic Heart Failure patients older than 65 years, consecutively referred to the A.R.C.A Campania Cardiologists in the pertaining healthcare districts
Key inclusion criteria (3 listed)
- Diagnosis of Heart Failure
- Signature of informed consent
- Age older than 65 years
Key exclusion criteria (4 listed)
- indication for cardiac surgery or cardiac surgery by less than 3 months
- age less than 65 years
- inability to perform periodic checks
- presence of malignant neoplasms and other severe diseases.
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
Number of patients treated with each of the following indicators of adherence to the current therapeutic guidelines:-ACEI -ARB -beta blockers -loop diuretics -aldosterone antagonists -digoxin -anticoagulant therapy - implantation of cardiac devices
Time frame: first physical examination and clinical evaluation performed during a 3 months period, from November 2012 to January 2013
1 secondary outcome
evaluate the prevalence of chronic heart failure among all the patients referring to the ambulatory cardiologists of the healthcare district
Time frame: first evaluation
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 18 Mar 2013.
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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.
1 site 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 Federico II University at 1 site in Italy.
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 4 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 18 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Number of patients treated with each of the following indicators of adherence to the current therapeutic guidelines:-ACEI -ARB -beta blockers -loop diuretics -aldosterone antagonists -digoxin -anticoagulant therapy - implantation of cardiac devices (time frame: first physical examination and clinical evaluation performed during a 3 months period, from November 2012 to January 2013). 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 18 Mar 2013.