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Heart Valve Diseases | Multicenter Study on Fibrotic Valvular Heart Disease in Patients With Parkinson's Disease Treated With Dopamine Agonists

Heart Valve Diseases research study

What is the primary objective of this study?

Fibrotic valvular heart diseases are known as rare complications of long-time therapy of Parkinson's disease with ergot-derivatives including some ergot-dopamine agonists. The aim of this study is to assess the incidence of valvular heart disease, which may be an ergot-drug agonists side-effect or an overall complication of all dopamine agonists. Incidence, prevalence and addiction of dose or intake duration are not known so far. The reversibility of the changes is unknown too. To answer these questions the present study is designed as a cross sectional study followed by a 2 year follow-up prospective cohort study.

Who is eligible to participate?

Inclusion Criteria: - Age > 18 years - Diagnosis of Morbus Parkinson - Written informed consent Exclusion Criteria: - Patients with a history of carcinoid syndrome - Patients with a history of post-inflammatory (rheumatic), degenerative (calcified) or ischaemic coronary heart or valvular heart disease - Previous medication with ergot-derived drugs (eg. Methysergide, Ergotamine) except dopamine receptor agonists or anorectic drugs (eg. Fenfluramine, Dexfenfluramine)

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Heart Valve Diseases

Parkinson's Disease

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Study Status

Unknown status

Start Date: March 2005

Completed Date: December 2013

Phase:

Type: Observational

Design:

Primary Outcome:

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Wolfgang Oertel, Prof. Dr.

Lead Sponsor: German Parkinson Study Group (GPS)

Collaborator: Competence Network on Parkinson's Disease

More information:https://clinicaltrials.gov/show/NCT00196898

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