A Mixed Methods Approach to Symptom Clusters in Black Women with Heart Failure Preserved Ejection Fraction: A Feasibility Study

Date Added
August 7th, 2020
PRO Number
Pro00101261
Researcher
Alexandra Ruppe

List of Studies

Keywords
Cardiovascular, Ethnicity and Disease, Heart, Minorities, Non-interventional, Shortness of Breath, Women's Health
Summary

This study aims to explore symptoms for Black women with heart failure using surveys and interviews. Black women have not been included in the majority of heart failure research. It is important that Black women have a voice and the ability to share their symptom experience. The goal of this research is to study clusters of heart failure symptoms in Black women to eventually improve symptom education, monitoring, and treatments.

Institution
MUSC
Recruitment Contact
Alexandra Ruppe
8034176635
moseleal@musc.edu

A Sham Controlled Prospective Randomized Clinical Trial of the RejuvenAir System for the Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease with Chronic Bronchitis (SPRAY-CB)

Date Added
April 28th, 2020
PRO Number
Pro00090634
Researcher
Charlie Strange

List of Studies

Keywords
Breathing, Lung, Pulmonary, Shortness of Breath
Summary

This research study will be evaluating whether liquid nitrogen sprayed on the cells lining the airways (cryotherapy) can reduce the mucus produced in the lungs of patients with chronic obstructive pulmonary disease (COPD). The study involves bronchoscopies, (placement of a lighted, flexible scope into the lungs) under general anesthesia to deliver the treatment to the lungs. The study is randomized such that 2/3 of individuals get the cryotherapy and the other 1/3 get a sham (control) treatment with no cryotherapy. Participants in the sham control group will be evaluated for eligible for cryotherapy at end of year one. The Study duration is 36 months. Those initially randomized to the treatment group, they will have 7 clinic visits and 2 treatment visits. Participants randomized to sham group will have 11 clinic visits and 4 treatment visits.

Institution
MUSC
Recruitment Contact
M. Gwen Blanton
843-792-8438
blantonm@musc.edu

Right Ventricular Reserve Measures with Cardiac MRI

Date Added
October 16th, 2019
PRO Number
Pro00085562
Researcher
Ryan Tedford

List of Studies

Keywords
Cardiovascular, Heart, Sarcoidosis, Scleroderma, Shortness of Breath
Summary

This research study aims to determine a less invasive way to assess heart function by taking measurements of the heart while subjects are performing an exercise cardiac MRI. Subjects will undergo two exercise phases and MRI measurements will be taken after each exercise phase. These measurements will be compared to available clinical data (including demographic, hemodynamic, radiologic, and functional) and future outcome data.

Institution
MUSC
Recruitment Contact
Melissa Lamicq
843-876-5783
lamicq@musc.edu

A Multicenter, Randomized, Sham-controlled Study to Evaluate Safety and Efficacy After Treatment with the Nuvaira™ Lung Denervation System in Subjects with Chronic Obstructive Pulmonary Disease (COPD) (AIRFLOW-3)

Date Added
August 27th, 2019
PRO Number
Pro00087312
Researcher
Charlie Strange

List of Studies

Keywords
Genetics, Lung, Pulmonary, Shortness of Breath
Summary

The primary purpose of this study is to see if the Targeted Lung Denervation (TLD) therapy (Active Treatment) is more effective than a sham procedure (Sham Control/no TLD therapy) at decreasing moderate or severe exacerbations in patients with COPD on optimal medical care. In addition, the study seeks to compare long-term safety, and other efficacy assessments, between the Active Treatment arm and the Sham Control arm.

TLD Therapy is done by passing a bronchoscope, with a special device (catheter) inserted through it, into the lungs. This special catheter delivers a type of electrical energy called radio frequency (or RF) energy to the nerves located on the outside of the airways. As with many bronchoscopic procedures, this is done while under anesthesia.

Participants will be randomly assigned (like flipping a coin) to receive one of two different treatments, either TLD Therapy in addition to optimal medical care (Active Treatment) or optimal medical care only (Sham Control). No matter which treatment you receive, you will undergo the same type of procedure, testing and follow-up while remaining on optimal medical care for COPD. You will have an equal chance of being assigned to either Active Treatment or the Sham Control group (1:1 randomization). Neither you or your study doctor will know which treatment you have received until after your 12-month follow-up visit. At the 12-month visit you will find out whether you received the active or sham procedure. If you received the sham procedure you have the option of crossing over into the treatment group and receiving TLD therapy.

Participation in the study will last for approximately 62 months. Depending on which group you are randomized to and if you decide to crossover to the treatment group, there will be 1-2 visits for TLD Therapy or sham control (non-active) procedure, 9-12 in-person clinic visits, and 13-23 phone visits.

Institution
MUSC
Recruitment Contact
Eryn Varano
843-792-1219
varanoe@musc.edu

A Multi-center, Randomized, 36-month, Parallelgroup, Non-inferiority, Phase III Study to Compare the Effectiveness of 500 mcg QD or alternate regimen of RofLumilast (Daliresp) Therapy Versus 250 mg QD, 500 mg QD three times per week or alternate regimen of Azithromycin Therapy to preveNt COPD Exacerbations (RELIANCE)

Date Added
July 16th, 2018
PRO Number
Pro00079290
Researcher
Charlie Strange

List of Studies

Keywords
Lung, Pulmonary, Shortness of Breath
Summary

The RELIANCE study is comparing two drugs, Roflumilast and Azithromycin, to treat COPD. Participants will be randomized to either take either Roflumilast or Azithromycin during the course of the study. Participation will last up to 3 years depending on when participants join. People who enroll at the beginning of the study will participate for approximately 3 years and people who enroll later in the study will be enrolled for a shorter amount of time. The study team will follow all participants for a minimum of 6 months.
There will be one in person visit at the beginning of the study where participants will be randomized to either take Roflumilast or Azithromycin. The remainder of the study will involve one follow-up phone call at 1 week and follow up phone calls every 3 months. The 3 month follow up phone calls will determine if there have been any hospitalizations, if the study participant is still taking their prescribed study medication and determine if contact information is still correct. The 3 month follow up questions can also be completed via an online patient portal if the patient prefers this method over receiving phone calls.

Institution
MUSC
Recruitment Contact
Eryn Varano
843-792-1219
varanoe@musc.edu

Scleroderma Lung Study III (SLS III): Combining the anti-fibrotic effects of pirfenidone (PFD) with mycophenolate (MMF) for treating scleroderma-related interstitial lung disease

Date Added
May 8th, 2018
PRO Number
Pro00077568
Researcher
Richard Silver

List of Studies

Keywords
Autoimmune disease, Drug Studies, Lung, Scleroderma, Shortness of Breath
Summary

This study will assess how 18 months of oral mycophenolate will compare to 18 months of mycophenolate plus pirfenidone, in the treatment of Systemic Sclerosis related Interstitial Lung Disease. Tolerability and toxicity will also be assessed, during this study.
This research is designed to test whether combining pirfenidone and mycophenolate will result in a more rapid and possibly greater improvement in lung function than occurs when mycophenolate is used alone. While both of these drugs have been approved by the U.S. Food and Drug Administration (FDA) to treat other medical conditions, neither drug has been FDA-approved for the treatment of scleroderma related lung disease. This research is being funded by the drug company, Genentech.

Institution
MUSC
Recruitment Contact
Nathan Wilson
843-792-8613
wilsonn@musc.edu

Early Intrapleural TPA Instillation Versus Late (ELEVATE)

Date Added
February 17th, 2017
PRO Number
Pro00058518
Researcher
Rohan Arya

List of Studies

Keywords
Cancer/Lung, Drug Studies, Infectious Diseases, Lung, Pulmonary, Shortness of Breath
Summary

When a chest tube is placed, it can be hard for the fluid to drain. Tissue plasminogen activator and DNase are given through the chest tube to help with draining the fluid. We are doing this research to see if early addition of tPA-DNase will help with better fluid draining.

Institution
Palmetto
Recruitment Contact
Rohan Mankikar
803-352-1237
rohan.mankikar@palmettohealth.org

A Phase 3/4 Study to Evaluate the Safety, Immunogenicity, and Effects on the Alpha1-Proteinase Inhibitor (A1PI) Levels in Epithelial Lining Fluid Following GLASSIA Therapy in A1PI-Deficient Subjects

Date Added
January 12th, 2016
PRO Number
Pro00046425
Researcher
Charlie Strange

List of Studies

Keywords
Breathing, Lung, Pulmonary, Rare Diseases, Shortness of Breath
Summary

Individuals with alpha-1 antitrypsin (AAT) deficiency (AAT blood level lower than 11 micro-moles) and emphysema will be invited to participate in this study. This study will determine the impact of IV Alpha-1 proteinase inhibitor (Alpha-1 MP) on the progression of emphysema in patients with AAT deficiency. A participant in this study would receive either GLASSIA dosed at 60mg/kg with a high particle load or GLASSIA dosed at 60mg/kg with a low particle load. Neither the study investigators nor the participants will know which batch of drug is actual given to the participant. Participants will have the IV therapies given to them weekly for 25 weeks, with some infusions given at MUSC and some at home. Safety and side effects of all therapies will be monitored.

Institution
MUSC
Recruitment Contact
M. Gwen Blanton
843-792-8438
blantonm@musc.edu

Protocol GTi1201: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Two Dose Regimens (60 mg/kg and 120 mg/kg) of Weekly Intravenous Alpha1-Proteinase Inhibitor (Human) in Subjects with Pulmonary Emphysema due to Alpha1-Antitrypsin Deficiency

Date Added
September 9th, 2014
PRO Number
Pro00033459
Researcher
Tatsiana Beiko

List of Studies

Keywords
Breathing, Lung, Pulmonary, Rare Diseases, Shortness of Breath
Summary

Individuals with alpha-1 antitrypsin (AAT) deficiency (AAT blood level lower than 11 micro-moles) and emphysema will be invited to participate in this study. This study will determine the impact of IV Alpha-1 proteinase inhibitor (Alpha-1 MP) on the progression of emphysema in patients with AAT deficiency. A participant in this study would receive any one of the following three therapies: 1) Alpha-1 MP dosed at 60mg/Kg, 2) Alpha-1 MP dosed at 120mg/Kg, or 3) Placebo. Once a subject is enrolled into this study, he/she will be randomly selected to receive only one of the above three therapies. Neither the study investigators nor the participants will know the actual therapy being given to the participants. All the study participants will receive serial chest CT scans to determine if their emphysema progresses over the following 3 years. Participants will have the IV therapies given to them weekly, with some infusions given at MUSC and some at home. Safety and side effects of all therapies will be monitored.

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



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