Physical Rehabilitation for Older Patients with Acute Heart Failure with Preserved Ejection Fraction (REHAB-HFpEF)

Date Added
December 29th, 2022
PRO Number
Pro00124781
Researcher
Sheldon Litwin

List of Studies


Keywords
Heart, Rehabilitation Studies
Summary

REHAB-HFpEF is a multicenter, randomized, attention-controlled, single-blind trial to examine the hypothesis that, a novel, tailored, progressive, multi-domain physical rehabilitation intervention administered to older patients with acute decompensated heart failure (ADHF) with preserved ejection fraction (HFpEF) beginning early during hospitalization and continuing for 12 weeks in a structured outpatient setting, and continuing as a maintenance program will reduce the rate of combined all-cause rehospitalization and death at 6 months (the primary outcome), and reduce major mobility disability (MMD) prevalence at 6 months (the secondary outcome). This trial, REHAB-HFpEF, builds upon preliminary studies, including the phase 2 REHAB-HF trial, which suggests this intervention may yield significant benefits for this population which are largely older, frail, and with few evidence-based treatment options.

The study will recruit a total of 880 consenting patients >=60 years old hospitalized with ADHF with HFpEF. Following informed consent and baseline testing, the participants will be randomized in a 1:1 fashion to receive a novel, progressive, multi-domain rehabilitation and exercise training intervention or attention control. The intervention will include strength, balance, endurance, and mobility training and the specific training exercises will be tailored based on participant performance in each of these domains. The intervention will begin as soon as possible after randomization during the hospitalization and will continue 3 times per week in an outpatient setting for 12 weeks. Those randomized to the attention control will be contacted bi-weekly by study staff to maintain contact, collect information regarding health status, clinical events, and physical activity/exercise, and ensure retention; they do not receive any specific exercise recommendations. Both arms will receive all services ordered by their primary physician (usual care) and undergo measures of physical function, cognitive function, and quality of life (QOL).

Institution
MUSC
Recruitment Contact
Renee Baxley
843-792-1105
baxleyr@musc.edu

A Feasibility Study of Peripheral Nerve Stimulation Therapy for Atrial Fibrillation.

Date Added
January 10th, 2023
PRO Number
Pro00125256
Researcher
Rachel Kaplan

List of Studies

Keywords
Heart, Nerve
Summary

This study's objective is to determine if electrical stimulation can safely reduced atrial fibrillation, which is an abnormal heart rhythm that begins in the top chambers of the heart. Electrical stimulation will be delivered to the wrists or in the ear. Participation will last about 6 weeks and require 3 clinic visits. Participants will be asked to wear a heart monitor and patch to monitor the heart rate and rhythm, keep a diary to collect information on atrial fibrillation, undergo randomization (being randomly assigned, like drawing straws) and use the study device per randomization assignment. Participants are randomized in a 1:1:1 fashion to a wrist worn study device, an ear piece study device or a sham wrist worn study device. A sham device looks like the real wrist worn device but does not deliver any electrical stimulation.

Institution
MUSC
Recruitment Contact
Deborah Everidge
843-792-2944
adamsde@musc.edu

A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Fazirsiran in the Treatment of Alpha-1 Antitrypsin Deficiency–Associated Liver Disease With METAVIR Stage F2 to F4 Fibrosis

Date Added
January 10th, 2023
PRO Number
Pro00125124
Researcher
Charlie Strange

List of Studies


Keywords
Pulmonary
Summary

This study will evaluate the safety and effectiveness of fazirsiran (investigational drug) compared with placebo (an inactive substance) in patients with alpha-1 antitrypsin deficiency associated liver disease (AATD-LD). If eligible, subjects will be randomized (assigned to a group by chance) to receive either fazirsiran or placebo to be administered subcutaneously (an injection under the skin). Subjects will be treated on Day 1, at Week 4, and then every 12 weeks for 196 weeks. Subjects will be followed for 6 months after their last dose of study drug or placebo for a total study duration of approximately 230 weeks (including 10 weeks of the screening period which is the time needed to assess if a subject is eligible for the study).

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

A Phase 2 Open-Label, Multicenter Clinical Study of the Safety, Efficacy, Pharmacokinetic, and Pharmacodynamic Profiles of CGT9486 as a Single Agent in Patients With Advanced Systemic Mastocytosis

Date Added
January 11th, 2023
PRO Number
Pro00123694
Researcher
Kelli Williams

List of Studies


Keywords
Blood Disorders, Cancer/Other, Immune System
Summary

The purpose of this study is determine the optimal dose, efficacy and safety of an investigational drug (a new drug not yet approved by the U.S. Food and Drug Administration) in adults with Advanced Systemic Mastocytosis. The investigational drug is known as CGT9486 and will be taken daily orally. Participation in the study is expected to be approximately 6 years.

Institution
MUSC
Recruitment Contact
Natalie Naylon
8437925824
naylon@musc.edu

A Neural Basis for Cognitive Decline Following Deep Brain Stimulation

Date Added
January 25th, 2023
PRO Number
Pro00125181
Researcher
Daniel Lench

List of Studies

Keywords
Brain, Parkinsons
Summary

The objective of this research study is to identify brain biomarkers using MRI scans that can predict an individual's response to Deep Brain Stimulation (DBS). A total of 55 participants with Parkinson's Disease planning to undergo DBS will be recruited from MUSC's Clinical DBS Program. Participants will undergo two visits which include a 2.5-hour pre-DBS questionnaire and MRI scanning visit, and a 3.5-hour post-DBS cognitive assessment visit. In addition control participants without Parkinson's Disease will be recruited to undergo MRI scanning and cognitive assessments.

Institution
MUSC
Recruitment Contact
Daniel Lench
843-792-9115
lenchd@musc.edu

A PHASE 3, OPEN-LABEL, RANDOMIZED, STANDARD OF CARECONTROLLED, PARALLEL ARM STUDY TO DEMONSTRATE EFFICACY AND SAFETY OF ARINA-1 IN THE PREVENTION OF BRONCHIOLITIS OBLITERANS SYNDROME PROGRESSION IN PARTICIPANTS WITH BILATERAL LUNG TRANSPLANT

Date Added
February 8th, 2023
PRO Number
Pro00126240
Researcher
Timothy Whelan

List of Studies


Keywords
Interstitial Lung Disease (ILD)
Summary

The study will be an open-label, randomized, parallel arm study that will include a
treatment arm and control arm. Participants will have clinic visits at screening, randomization (day 1) and weeks 4, 12, 18, and 24. After week 24, participants will have clinic visits at weeks 32, 40, and 48. Participants will also have a telehealth visit on day 2 and phone calls to assess adverse events (AEs), serious adverse events (SAEs), and review patient education will occur during weeks 5, 8, 36, and 44. The phone calls may be converted to telehealth visits or clinic visits and / or followed by clinic visits, if the study team deems it necessary. Pulmonary function testing, quality of life survey (St. George's Respiratory Questionnaire (SGRQ)), and blood draw will occur at each clinic visit.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

Examining Provider and Caregiver Perceptions of an Automated Clinical Support Tool to identify Child Risk in Primary Care

Date Added
February 12th, 2023
PRO Number
Pro00125560
Researcher
Hannah Espeleta

List of Studies

Keywords
Children's Health, Pediatrics
Summary

This study wants to understand how we can better identify children who have experienced or are at risk to experience child maltreatment. We will be interviewing caregivers of children and primary care providers (nurses, pediatricians, social workers) to understand their perspectives on screening for child safety risks in primary care settings. Interviews with providers will also focus on their feedback on a new tool to designed to detect child safety risks within health care settings. Findings will help inform best practice in integrated health care settings.

Institution
MUSC
Recruitment Contact
Hannah Espeleta
843-792-6098
espeleta@musc.edu

A PHASE 3 RANDOMIZED, DOUBLE-BLIND, 52-WEEK PLACEBOCONTROLLED, MULTI-CENTER STUDY INVESTIGATING THE EFFICACY, SAFETY, AND TOLERABILITY OF RITLECITINIB IN ADULT AND ADOLESCENT PARTICIPANTS WITH NON SEGMENTAL VITILIGO

Date Added
March 2nd, 2023
PRO Number
Pro00126424
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

Ritlecitinib (PF 06651600) is an investigational drug (referred to as "study drug" from here on) and is being developed as possible study treatment for participants with non segmental vitiligo (both active and stable vitiligo). The study drug will be compared with a placebo to find out if the study drug is better than the placebo for the study treatment of vitiligo. The duration of this study is a maximum of 60 weeks. There will be an initial screening period of 30 days where the study doctor will determine eligibility. If eligible, participants will be randomly assigned to receive the study drug or a placebo during a 52 week study treatment period. At the end of the treatment period, participants will enter a 4 week Follow Up Period.

Institution
MUSC
Recruitment Contact
Tiffany Vereen
843-792-6882
vereent@musc.edu

PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr adults (PREVENTABLE)

Date Added
March 6th, 2023
PRO Number
Pro00125689
Researcher
Leslie Lenert

List of Studies


Keywords
Cholesterol, Dementia, Drug Studies, Geriatrics, Healthy Volunteer Studies, Heart, Memory Loss, Stroke Recovery
Summary

The purpose of this research study is to determine if an already FDA approved drug called atorvastatin can help adults, age 75 or older, live well for longer by preventing dementia, disability, or heart disease. Participants will be assigned by chance to receive either atorvastatin (study drug) or a matching placebo (a tablet that looks like atorvastatin but does not contain any medicine). Study engagement may last up to five years and involves in clinic and/or remote visits, survey questions, potential blood draws, in addition to memory and physical tests. After the first 1-2 visits performed in clinic or remote, the study team will follow-up via phone on a yearly basis to see how participants are doing. Participants will be compensated for their time and participation in this research study.

Institution
MUSC
Recruitment Contact
Amy Reynolds
(843) 792-8459
reynoamy@musc.edu

PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr adults (PREVENTABLE)

Date Added
March 6th, 2023
PRO Number
Pro00125689
Researcher
Leslie Lenert

List of Studies


Keywords
Cholesterol, Dementia, Drug Studies, Geriatrics, Healthy Volunteer Studies, Heart, Memory Loss, Stroke Recovery
Summary

The purpose of this research study is to determine if an already FDA approved drug called atorvastatin can help adults, age 75 or older, live well for longer by preventing dementia, disability, or heart disease. Participants will be assigned by chance to receive either atorvastatin (study drug) or a matching placebo (a tablet that looks like atorvastatin but does not contain any medicine). Study engagement may last up to five years and involves in clinic and/or remote visits, survey questions, potential blood draws, in addition to memory and physical tests. After the first 1-2 visits performed in clinic or remote, the study team will follow-up via phone on a yearly basis to see how participants are doing. Participants will be compensated for their time and participation in this research study.

Institution
MUSC Health Chester Medical Center
Recruitment Contact
Amy Reynolds
(843) 792-8459
reynoamy@musc.edu



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