NCT01813331

Brief 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. Secondary objective is to evaluate the prevalence of chronic heart failure among all the patients referring to the ambulatory cardiologists of the healthcare district.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
660

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

November 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 7, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 18, 2013

Completed
Last Updated

March 18, 2013

Status Verified

March 1, 2013

Enrollment Period

2 months

First QC Date

March 7, 2013

Last Update Submit

March 13, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    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

    first evaluation

Study Arms (1)

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.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
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

You may qualify if:

  • Diagnosis of Heart Failure
  • Signature of informed consent
  • Age older than 65 years

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ARCA Campania healthcare ambulatories

Naples, Italy

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 7, 2013

First Posted

March 18, 2013

Study Start

November 1, 2012

Primary Completion

January 1, 2013

Study Completion

February 1, 2013

Last Updated

March 18, 2013

Record last verified: 2013-03

Locations