ClinConnect ClinConnect Logo
Search / Trial NCT04218968

Cardiac Changes in Early Parkinson's Disease: a Follow Up Study

Launched by CEDARS-SINAI MEDICAL CENTER · Jan 2, 2020

Trial Information

Current as of June 26, 2025

Enrolling by invitation

Keywords

ClinConnect Summary

Primary procedures in this study are MIBG scan, DAT scan, Neuromelanin Magnetic Resonance Imaging (NM-MRI), and carvedilol treatment. Subjects will return for research visits and imaging tests every six months for three years. We hypothesize that the rate of decline in DAT scan123I-Ioflupane uptake will be slower in subjects who have received the adrenergic blocker carvedilol, resulting in a decreased clinical phenoconversion rate to parkinsonism. If this is true, it might create a considerable window of opportunity for treatment with adrenergic blockers - or similar compounds able to reduc...

Gender

ALL

Eligibility criteria

  • 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
  • Allergy/hypersensitivity to iodine or study medication

About Cedars Sinai Medical Center

Cedars-Sinai Medical Center is a renowned nonprofit academic medical center located in Los Angeles, California, recognized for its commitment to patient care, research, and education. As a leading institution in clinical trials, Cedars-Sinai harnesses innovative approaches to advance medical knowledge and improve treatment outcomes across various specialties. With a multidisciplinary team of experts, state-of-the-art facilities, and a patient-centered approach, Cedars-Sinai actively contributes to the development of novel therapies and interventions, ensuring the highest standards of clinical research while prioritizing patient safety and ethical considerations.

Locations

Los Angeles, California, United States

Los Angeles, California, United States

Patients applied

0 patients applied

Trial Officials

Michele L Lima Gregorio, MD, FAAN

Principal Investigator

Cedars-Sinai Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Similar Trials