A Follow-Up, Open-Label, Research Evaluation of Sustained Treatment with Aficamten (CK-3773274) in Hypertrophic Cardiomyopathy (HCM)

Date Added
June 11th, 2024
PRO Number
Pro00137149
Researcher
Jessica Atkins

List of Studies

Keywords
Cardiovascular, Drug Studies, Heart, Men's Health, Women's Health
Summary

This study is for patients with hypertrophic cardiomyopathy (HCM). HCM is a condition where the heart muscle becomes abnormally thickened, which can sometimes block the blood flow out of the heart and results in the heart muscle working harder to pump blood to the body. Participants who have completed participation in a previous HCM study investigating the study drug, called aficamten (CK-3773274), will be eligible to participate in this study.

The study is done to collect long-term safety and tolerability data, including assessments of cardiac structure and function during chronic dosing with aficamten. Aficamten is a tablet taken by mouth. This is an open label study (the participants and study team will know the dose of aficamten taken at any given time). If your screening results show you are eligible to continue in the study, you will visit the research site for the "first dosing day" (Day 1), followed by visits at Weeks 2, 4, 6, 12, then every 12 weeks thereafter. Study related procedures include blood work, echocardiograms (ultrasound test of the heart), electrocardiogram (recording of heart's electrical activity), physical exams, and questionnaires. Risks associated with this study include shortness of breath, nausea, diarrhea, headaches and dizziness.

Institution
MUSC
Recruitment Contact
Cara Breunig
843-792-7519
breunig@musc.edu

A Phase 3b/4 Randomized, Open-label, Efficacy Assessor-Blinded Study, to Evaluate the Efficacy and Safety of Upadacitinib for the Treatment of Adult Subjects with Moderate to Severe Atopic Dermatitis and Inadequate Response to Dupilumab (SWITCH-UP)

Date Added
June 12th, 2024
PRO Number
Pro00137232
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This is a global, Phase 3b/4, randomized, open-label, efficacy assessor-blinded, multi-center study that will evaluate upadacitinib compared to dupilumab in adult subjects with moderate to severe AD and inadequate response to dupilumab after at least 6 months of current use. The study consists of a 35-day Screening Period; an 8-week randomized, open-label, efficacy assessor blinded treatment period for all participants (Period 1); a 24-week open-label, efficacy assessor-blinded extension period for all participants who finish Period 1 (Period 2) (total duration of Period 1 and Period 2 is 32 weeks); and a 30-day Follow-up visit.

Institution
MUSC
Recruitment Contact
Alyson Winter
843-876-3209
wintera@musc.edu

Prophylactic Intra-Operative Ventricular Arrhythmia Ablation in High-Risk LVAD Candidates (PIVATAL)

Date Added
June 12th, 2024
PRO Number
Pro00132289
Researcher
Arman Kilic

List of Studies

Keywords
Cardiovascular
Summary

The study will evaluate the effect of prophylactic intra-operative ventricular tachyarrhythmia ablation (VTA) at the time of left ventricular assist device (LVAD) implantation on post-implant total recurrent VTA events, after accounting for the competing risk of death, from discharge to an average follow-up of 18 months (with a minimum of 9 months) after LVAD implantation.

Institution
MUSC
Recruitment Contact
Morgan Overstreet
(843) 792-8896
overstrm@musc.edu

Research Evaluating Vagal Excitation and Anatomical Links

Date Added
June 13th, 2024
PRO Number
Pro00136451
Researcher
Mark George

List of Studies


Keywords
Depression, Epilepsy, Mental Health
Summary

This is an NIH sponsored trial across the US where patients who have been or will be implanted with cervical vagus nerve stimulation (VNS) are then tested in a variety of ways to determine the activity of the VNS on different organs in their body. This will involve implantation for those who qualify, and then two trips to the University of Minnesota for more extensive testing. The device, implantation and travel are all at no cost.

Institution
MUSC
Recruitment Contact
Morgan Dancy
843-876-5141
maddoxm@musc.edu

Treatment In Thoracic Aortic Aneurysm: Surgery versus. Surveillance (TITAN:SvS)

Date Added
June 18th, 2024
PRO Number
Pro00129203
Researcher
Sanford Zeigler

List of Studies


Keywords
Cardiovascular
Summary

To undertake the first prospective randomized controlled trial that compares early aortic surgery to aneurysm surveillance.

The purpose of the study is to compare different treatment plans for patients with abnormal aortas. Patients who have an abnormal aorta measuring at least 5.5cm will have surgery to replace the aorta. We do not know, however, whether patients with abnormal aortas that are not quite 5.5cm should have surgery or should be monitored to see if their aorta continues to grow. Therefore, through this registry and interventional study, the hope is to collect more data on which treatment is better for the patient. The interventional group will undergo surgery to repair their abnormal aorta, and the surveillance group will be closely monitored and medically managed per standard of care. Both groups will have data collected from their care and at the end of the study this data will be analyzed. The goal of this study is to determine if performing surgery earlier helps to prevent abnormal aortas below 5.5cm from tearing or bursting.

Institution
MUSC
Recruitment Contact
Hannah Culpepper
8437927244
culpepph@musc.edu

A Phase II Study of Fingolimod in Patients with Non-Small Cell and Small Cell Lung Cancer

Date Added
June 18th, 2024
PRO Number
Pro00137404
Researcher
Mariam Alexander

List of Studies

Keywords
Cancer, Cancer/Lung, Cancer/Other, Drug Studies, Lung, Men's Health, Women's Health
Summary

This study is for subjects that have been diagnosed with lung cancer and the disease has progressed on prior therapy. The purpose of the study is to determine the safety and efficacy of Fingolimod and whether it can aid in treatment against lung cancer tumors. Fingolimod is not FDA approved and is considered an investigational drug. Subjects can expect to be in this study for about 8 months, with routine visits occurring at MUSC.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Retatrutide on the Incidence of Major Adverse Cardiovascular Events and the Decline in Kidney Function in Participants with Body Mass Index ≥ 27 kg/m2 and Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease

Date Added
June 25th, 2024
PRO Number
Pro00136763
Researcher
Sheldon Litwin

List of Studies


Keywords
Cardiovascular, Kidney, Obesity, Stroke Recovery
Summary

Individuals with obesity and a history of heart or kidney-related disease will be eligible for participation. Study participants will have a 50:50 chance to be randomly assigned to either the treatment (retatrutide) or control (placebo) group. Retatrutide is currently considered an investigational medication as it has not been approved by the FDA for the treatment of obesity or any other medical condition at this time. Study participation will last approximately 5 years and begin with a screening period to ensure correct patient selection. Research clinic visits will occur every 4 weeks initially and then every 12 weeks. Some visits may be completed virtually through telehealth or by phone. Study procedures include but are not limited to: blood draws, questionnaires, self injection of study medication, medical history review, vital signs, and electrocardiogram. The medication will be injected subcutaneously once a week. The medication's purpose is to facilitate weight loss and decrease a subject's risk for heart or kidney related disease progression or events.

Institution
MUSC
Recruitment Contact
Elhaam Borhanian
843-792-5873
borhania@musc.edu

RELIANCE: A phase 1, randomized, double-blinded, placebo-controlled, trial evaluating the long-term safety and tolerability of Imatinib for the treatment of Lymphangioleiomyomatosis (LAMP-2 Trial)

Date Added
July 30th, 2024
PRO Number
Pro00136539
Researcher
Charlie Strange

List of Studies


Keywords
Kidney, Lung, Pulmonary, Rare Diseases, Women's Health
Summary

The purpose of this medical research study is to evaluate the safety and effectiveness of a new medication called imatinib mesylate in the treatment of Lymphangioleiomyomatosis (LAM). LAM is a rare disease in which abnormal cells (called LAM cells) grow out of control. Over time, LAM cells destroy healthy lung tissue and cause respiratory disease or failure.

Many patients with LAM are currently treated with a medication called sirolimus (rapamycin). Sirolimus slows the growth of LAM cells.

Imatinib mesylate (hereafter called imatinib) is approved by the Food and Drug Administration (FDA) for the treatment of some cancers that share common pathways with LAM cells. Laboratory studies suggest that imatinib could completely block the growth of LAM cells through initiation of targeted cell death.

An important purpose of this research is to determine the safety of imatinib in people with LAM. This study will also evaluate the short-term effectiveness of imatinib. Participants will be randomized to receiving imatinib (study medication) or placebo (no treatment) for the 180 day duration of participation. The study is being conducted at the Medical University of South Carolina and at Columbia University in New York (CUMC). Each site will enroll 10 participants.

Institution
MUSC
Recruitment Contact
Mary Hayden
(843) 792-8438
blantonm@musc.edu

Aging Neural Systems and Communication Difficulties

Date Added
August 2nd, 2024
PRO Number
Pro00135808
Researcher
Kenneth Vaden

List of Studies


Keywords
Aging, Brain, Healthy Volunteer Studies, Hearing
Summary

As people get older, understanding speech in a noisy environment can become more difficult. The MUSC Hearing Research Program is seeking healthy adults between 25 and 89 years of age to participate in a research study to investigate the connection between listening difficulties and the brain. Payment is provided for participation and scheduling is flexible. The study involves two visits. Participants must be able to complete an MRI. Please contact us if you would like to participate in this research or learn more about our study.

Institution
MUSC
Recruitment Contact
Kenneth Vaden
8437925916
scanlab@musc.edu

Tracking Brain Imaging Changes in Depression over Clinical Accelerated TMS Therapy at the Individual Level

Date Added
August 6th, 2024
PRO Number
Pro00138260
Researcher
Xiaolong Peng

List of Studies


Keywords
Brain, Depression
Summary

The aim of this study is to use magnetic resonance imaging (MRI) to capture images of participants' brains and apply an image processing method called INSCAPE to assess brain states. This study will recruit participants who are scheduled to receive accelerated Transcranial Magnetic Stimulation (TMS) therapy for Major Depressive Disorder (MDD). Participation in this study involves two visits, each including a 30-minute MRI scan. The interval between each visit is about one week. Depressed participants will also complete mood assessments at various intervals while they are receiving accelerated TMS for depression.

Institution
MUSC
Recruitment Contact
Katherine Tucker
843-792-9502
tuckekat@musc.edu



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