Effects of Angiotensin Converting Enzyme (ACE) Inhibitors Versus Candesartan in Reducing Cardiovascular Events in Primary Treatment of Hypertension

Effects of Angiotensin Converting Enzyme Inhibitors vs Candesartan in Reducing Cardiovascular Events in Primary Treatment of Hypertension

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01152567

Acronym

ARBACE

Enrollment

50000

Registered

2010-06-29

Start date

2010-06-30

Completion date

2010-11-30

Last updated

2011-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, Hypertension

Keywords

Hypertension, ACE, ARB, real life data, CVD, cost effectiveness

Brief summary

The planned Study will be a retrospective study on the effect of ACE's vs. candesartan on cardiovascular events and on health economic effects in a real life setting in Sweden.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

17 Years to No maximum

Healthy volunteers

Inclusion criteria

* all patients found in electronic patient journals at the participating centres, who were prescribed either ACEis (ATC-C09A-B) or ARBs (C09C-D) for hypertension from 1 January 1999 - 31 December 2007. The first date of such a prescription starts the observation time and is called the index prescription.

Exclusion criteria

* No history of cardiovascular disease. * Ongoing malignancy

Design outcomes

Primary

Measure	Time frame
Investigate the risk of Cardiovascular Disease (CVD) and new onset diabetes in patients on primary hypertensive treatment with ACE or candesartan for hypertension	Time to first CV event calculated as the time (in days) between date of index prescription and date of the first registration of a CV event. Patients will be followed for min. 1 wk and up to 9 yrs (1999-2007). Median follow up time is estimated to 2 yrs.

Secondary

Measure	Time frame
To investigate the risk of CVD and new onset diabetes in patients treated with specific types of ACEi or candesartan for hypertension	Time to first CV event calculated as the time (in days) between date of index prescription and date of the first registration of a CV event. Patients will be followed for min. 1 wk and up to 9 yrs (1999-2007). Median follow up time is estimated to 2 yrs.
To investigate the risk of hypertensive organ damage, renal failure and hyperlipidemia for patients treated with ACEi or candesartan	Time to first CV event calculated as the time (in days) between date of index prescription and date of the first registration of a CV event. Patients will be followed for min. 1 wk and up to 9 yrs (1999-2007). Median follow up time is estimated to 2 yrs.
Evaluate differences in use of health care resources, and assess the potential long term cost effectiveness	Differences in health care consumption will be estimated through models incorporating normalised costs, level of care, age, gender and study year

Countries

Sweden

Outcome results