Cardiac Changes in Early Parkinson's Disease: A Follow up Study (NCT04218968) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Cardiac Changes in Early Parkinson's Disease: A Follow up Study
United States15 participantsStarted 2019-12-30
Plain-language summary
The purpose of this study is to investigate the long-term effects of treatment with the adrenergic blocker carvedilol on serial DaTscan, a dopamine transporter (DAT) single photon emission computerized tomography (SPECT) imaging technique in a population of subjects with defined pre-motor Parkinson's disease risks (i.e., REM sleep Behavior Disorder (RBD) and at least one among hyposmia, constipation, depression and color vision abnormality) and abnormal 123I-Metaiodobenzylguanidine (MIBG) scintigraphy.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion Criteria:
* Enrolled in the study "The Effect of Adrenergic Blocker Therapy on Cardiac and Striatal Transporter Uptake in Pre-Motor and Symptomatic Parkinson's Disease" (Pro#00053136)
* Capacity to give informed consent
Exclusion Criteria:
* Secondary Parkinsonism, including tardive
* Concurrent dementia defined by a score lower than 22 on the MoCA
* Concurrent severe depression defined by a BDI fast screen score greater than 13
* Comorbidities related to SNS hyperactivity
* Heart failure (LVEF \<45%)
* Recent myocardial revascularization (\<12 weeks)
* Hypertension (SBP\>150mmHg or DBP\>100mmHg)
* Chronic Atrial fibrillation
* Concurrent Use of Beta-adrenergic antagonist
* Diabetes mellitus
* COPD
* Untreated Sever Sleep Apnea; Apnea-Hypopnea Index (AHI) \> 30/h.
* Severely reduced kidney function (Glomerular Filtration Rate\<30ml/min)
* Contraindications to the use of carvedilol
* Asthma or bronchospasm
* Recent myocardial infarction (\<48 h)
* Ongoing unstable angina
* Cardiogenic shock or prolonged hypotension
* Second or Third-Degree AV block
* Significant valvular aortic stenosis
* Obstructive cardiomyopathy, or constrictive pericarditis
* Resting Heart Rate (RHR)\< 45 Or Bradycardia (HR\<60) with at least one of the following symptoms; Lightheadedness, dizziness, weakness, Altered mental status, Shortness of breath, Pre-Syncope, Syncope, Sick Sinus Syndrome, Stroke within the past 1 month, Severe Hepatic Dysfunction
* Al…