NCT02236741

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
26,814

participants targeted

Target at P75+ for all trials

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, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2014

Completed
Last Updated

September 11, 2014

Status Verified

September 1, 2014

Enrollment Period

1.1 years

First QC Date

September 10, 2014

Last Update Submit

September 10, 2014

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Assessment of first-time clinical diagnosis of heart failure

    150 months

Secondary Outcomes (1)

  • Overall rate of heart failure

    150 months

Study Arms (1)

users of anti-parkinsonian drugs

Drug: Mirapexin® (Sifrol®)

Interventions

Mirapexin® (Sifrol®)DRUG
users of anti-parkinsonian drugs

Eligibility Criteria

Age40 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Users of anti-parkinsonian drugs registered with an up-to-standard practice from the United Kingdom's General Practice Research Database (GPRD)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Failure

Interventions

Pramipexole

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

BenzothiazolesThiazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2014

First Posted

September 11, 2014

Study Start

November 1, 2009

Primary Completion

December 1, 2010

Last Updated

September 11, 2014

Record last verified: 2014-09