Cardiac Changes in Early Parkinson's Disease: A Follow up Study

Running, not enrolling · Phase 2

Conditions studied: REM Sleep Behavior Disorder, Pre-motor Parkinson Disease, Symptomatic Parkinson Disease

In brief

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.

Key facts

Study ID

NCT04218968

Run by

Cedars-Sinai Medical Center

People needed

15

Starts

2019-12-30

Expected to finish

2026-06-30

Last updated by the study team

2026-03-02

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Allergy/hypersensitivity to iodine or study medication

Where it is running

• Michele L Lima Gregorio — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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