The Use of Pramipexole and Other Dopamine Agonists and the Risks of Heart Failure and Pneumonia

Completed

• Conditions: Heart Failure
• Interventions: Drug: Mirapexin® (Sifrol®)

• Registration Number: NCT02236741
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Study to assess the risk of incident heart failure associated with the use of pramipexole compared with other dopamine agonists and additionally, to assess the risk of incident heart failure associated with the use of dopamine agonists in comparison with no use of dopamine agonist therapy

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Primary Completion: 2010-12
• Status Verified: 2014-09
• Study First Submitted: 2014-09-10
• Study First Submitted QC: 2014-09-10
• Last Update Submitted: 2014-09-10
• Study First Posted: 2014-09-11
• Last Update Posted: 2014-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26814

Inclusion Criteria

• All patients between 40 and 89 years of age who received at least one prescription for anti-parkinsonian drugs during the period 1997-2009

Exclusion Criteria

• Patients with a diagnosis of heart failure or with prescriptions for two or more among the digitalis, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor blocker (ARB), and diuretic drug classes prior to cohort entry

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
users of anti-parkinsonian drugs	Mirapexin® (Sifrol®)	-

Primary Outcome Measures

Name	Time	Method
Assessment of first-time clinical diagnosis of heart failure	150 months

Secondary Outcome Measures

Name	Time	Method
Overall rate of heart failure	150 months