Pulmonary Artery Denervation Clinical Study using the Gradient Denervation System in Heart Failure Patients with Pulmonary Hypertension Group 2

Date Added
March 26th, 2024
PRO Number
Pro00135798
Researcher
Thomas Todoran

List of Studies


Keywords
Cardiovascular, Heart, Pulmonary Hypertension
Summary

This study is for patients who have heart failure with pulmonary hypertension. Heart failure means that the heart cannot pump blood as well as normal. Pulmonary hypertension happens when the pressure in the blood vessels leading from the heart to the lungs is too high, blood flowing through the lungs is limited, and the pressure in the lungs increases when you are physically active, causing symptoms of shortness of breath and tiredness.

The study uses the Gradient device to see if can help treat heart failure with pulmonary hypertension. This device and therapy is still investigational, which means it is currently not approved by a regulatory agency (such as U.S Food and Drug Administration) for regular hospital use and it includes only individuals who choose to take part. Risks in this study include those for standard cardiac catheterization techniques and the administration of anesthesia including allergic reactions, low blood pressure, skin rash, or difficulty breathing; however, all of the risks may not be known. The study will last approximately 3 years and includes the following visits: Baseline/Screening, Procedure, Discharge, 1 month, 6 months and visits annually for 3 years. Study related procedures include a physical exam, blood testing, 6 minute walk test, echocardiogram, CT scan and a Right heart catheterization.

Institution
MUSC
Recruitment Contact
Anthony Awkar
843 876-5009
awkar@musc.edu

A Phase 3, Multi-Center, Randomized, Double-Blind Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults with Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy

Date Added
February 13th, 2024
PRO Number
Pro00134508
Researcher
Jessica Atkins

List of Studies

Keywords
Drug Studies, Heart
Summary

This study is enrolling subjects with non-obstructive hypertrophic cardiomyopathy (nHCM). nHCM is typically a genetic condition in which the main pumping chamber of the heart (called the left ventricle) becomes abnormally thickened and stiff, which makes it harder for the ventricle to fill and pump out enough blood. This study involves the investigational medication Aficamten, which means it is not approved for commercial use by the Food and Drug Administration. (FDA) Aficamten is designed to reduced excessive heart pumping function. This is a randomized study which means all subjects are assigned to receive either Aficamten or placebo. Subjects have a 50:50 chance of being assigned to either group, but will not know which group they are assigned. Placebo looks like the medication but does not have any active ingredients in it. Study procedures include exercise testing, echocardiograms (ultrasound test of the heart), blood work, questionnaires and genetic testing. Study risks include risks associated with the study medication including decreased heart pumping, nausea, headache and dizziness. There are also study procedure related risks, and the risk of loss of confidentiality. There may be no benefit but the information learned may benefit others in the future. Study participation will last between 10.5 and 19 months and include up to 13 visits to the study site. Visits will generally last 2-3 hours.

Institution
MUSC
Recruitment Contact
Ellie Cutright
843-876-5011
cutrighe@musc.edu

REACT-AF: The Rhythm Evaluation for Anticoagulation with Continuous Monitoring of Atrial Fibrillation

Date Added
February 3rd, 2024
PRO Number
Pro00132508
Researcher
Venkateshwar Gottipaty

List of Studies

Keywords
Cardiovascular, Heart
Summary

This research is being done to assess whether it is safe and effective to stop oral anticoagulation medications (a blood-thinning medication) during prolonged periods of normal heart rhythm in participants with infrequent episodes of atrial fibrillation (AF).

You may qualify for this study if you have a history of atrial fibrillation (AF) and are currently taking an oral anticoagulant (a blood-thinning medication). You will be randomized to one of two groups: Control Group or Study Intervention Group.

If you are randomized to the Control group, you will be asked to stay on your previously prescribed oral anticoagulant. If you are randomized to the Study Intervention group, you will be asked to take the oral anticoagulant for 30 days only if a prolonged episode of AF is detected on an AF-sensing Apple smartwatch you will be provided.

Institution
MUSC
Recruitment Contact
Jacqueline Sheriod-Scott
803-254-3278
sheriods@musc.edu

REACT-AF: The Rhythm Evaluation for Anticoagulation with Continuous Monitoring of Atrial Fibrillation

Date Added
February 3rd, 2024
PRO Number
Pro00132508
Researcher
Venkateshwar Gottipaty

List of Studies

Keywords
Cardiovascular, Heart
Summary

This research is being done to assess whether it is safe and effective to stop oral anticoagulation medications (a blood-thinning medication) during prolonged periods of normal heart rhythm in participants with infrequent episodes of atrial fibrillation (AF).

You may qualify for this study if you have a history of atrial fibrillation (AF) and are currently taking an oral anticoagulant (a blood-thinning medication). You will be randomized to one of two groups: Control Group or Study Intervention Group.

If you are randomized to the Control group, you will be asked to stay on your previously prescribed oral anticoagulant. If you are randomized to the Study Intervention group, you will be asked to take the oral anticoagulant for 30 days only if a prolonged episode of AF is detected on an AF-sensing Apple smartwatch you will be provided.

Institution
MUSC Health Columbia Medical Center
Recruitment Contact
Jacqueline Sheriod-Scott
803-254-3278
sheriods@musc.edu

A PHase 1/2 Study of the Safety and Efficacy of LX2020 Gene TheRapy in Patients with ArrhythmOgenIc Cardiomyopathy (ACM) due to a PlaKoPhilin-2 (PKP2) Pathogenic Variant

Date Added
January 23rd, 2024
PRO Number
Pro00133595
Researcher
Daniel Judge

List of Studies


Keywords
Cardiovascular, Heart
Summary

This study is seeking participants with arrhythmogenic cardiomyopathy (ACM), also known as arrhythmogenic right ventricular dysplasia/cardiomyopathy (ARVD/C), due to a genetic abnormality known as a PKP2 variant. ARVD/C is an inherited disease where the muscle tissue in the right ventricle, one of the lower pumping chambers of the heart, dies and is replaced with scar tissue. This causes a weakened heart muscle and disrupts the heart's electrical system which can lead to heart failure and/or fatal heart rhythms. This study is looking at the safety and effectiveness of an investigational medication, meaning it is not yet approved for use by the Food and Drug Administration (FDA). The study medication is a gene therapy called LX-2020, and is designed to add new PKP2 genes to replace the faulty ones so your cells can make the correct PKP2 genes. The study medication is given via an intravenous (IV) line meaning in a vein. Participation in this study involve up to 25 visits including a hospitalization over the course of 1 year with an additional 4 years of follow up afterwards. Study related procedures include a variety of heart testing like electrocardiogram (ECG), echocardiogram, a test that records a tracing of the heart's electrical activity, Echocardiogram, (echo) a test that uses ultrasound to capture moving images of the heart, magnetic resonance imaging (MRI), a test that shows an image of the heart and surrounding structures, sample collection including blood, urine, tissue, nasal mucus, saliva and stool, liver ultrasound, questionnaires, physical exams, and at least a two night stay in the hospital. Medications to suppress (meaning weaken) the immune system, before receiving the LX2020 are also required. Risks associated with gene therapy include an immune response that may cause inflammation in the liver, heart or other organs. It may damage red blood cells, cause a low platelet count or cause the formation of small blood clots. There are also risk related to the study procedures including bleeding associated with the heart biopsy, risks related to drawing blood, risks of radiation, and loss of confidentiality. There is potential benefit and in the future, others with ACM may benefit from the knowledge gained from this study.

Institution
MUSC
Recruitment Contact
Ellie Cutright
843-876-5011
cutrighe@musc.edu

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients With Heart Failure With Preserved Left Ventricular Ejection Fraction (PH-HFpEF); LEVEL: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF

Date Added
January 9th, 2024
PRO Number
Pro00132012
Researcher
Daniel Silverman

List of Studies

Keywords
Cardiovascular, Heart
Summary

The purpose of the study is to evaluate the safety and how well the medication levosimenden works versus placebo in treating Pulmonary Hypertension and Heart Failure with a Preserved Ejection Fraction measured by a 6 minute walk. This is a condition where the lower left chamber (left ventricle) of the heart is not able to fill properly with blood during the filling phase and the amount of blood pumped out to the body is below normal. The study will also look at information obtained from the tests performed as part of the study to see if subjects have improvement in symptoms of heart failure. Levosimendan is a drug that has been FDA-approved for intravenous (IV) delivery to your body. This study aims to determine if the tablet form of the drug is as effective as the IV route. Tablets are much more attainable for patients to manage their heart failure from home, rather than going to an infusion clinic for treatments. Participation in this study will last approximately 12 weeks with the option to continue to the stage 2 phase of the study. If the stage 2 phase is selected as well, participation will last approximately 26 months or a little over 2 years. These visits will include such activities as blood tests, questionnaires, physical evaluation by a study doctor, echocardiogram, and 6 minute hall walks.

Participants will be randomized to either the treatment group (and receive the medication) or the control group (receive an inactive medication). Subjects will have a 50:50 chance of receiving the study medication during their participation in the trial. The treatment assignment is determined by randomization, where a computer selects at random which treatment group you will be in (like drawing straws). Neither the subject, nor the blinded personnel will know which group subjects are in. Neither the subject nor the study doctor will decide what group subjects are assigned.

Institution
MUSC
Recruitment Contact
Shaquanda Ross-Simmons
843-876-5783
shr37@musc.edu

Seroprevalence Study of Pre-existing Antibodies Against Adenovirus-associated Virus Vector (AAV) in Patients with Plakophilin 2 (PKP2)-associated Arrhythmogenic Right Ventricular Cardiomyopathy(ARVC)

Date Added
January 5th, 2024
PRO Number
Pro00132416
Researcher
Daniel Judge

List of Studies


Keywords
Cardiovascular, Heart
Summary

The purpose of this study is to collect information about patients with Arrhythmogenic right ventricular cardiomyopathy(ARVC) and about the disease. ARVC is a rare condition that affects heart muscle and causes abnormal heart rhythms (this is called "arrhythmia"). Participation in this study will take about 5 years. If your study doctor determines you are eligible and you agree to participate, you will be asked to visit the study doctor's office as part of your regular care for a screening visit and about 1 time each year for the length of the study. The majority of the data collected for this study will be part of your regular care, however study related procedures include arrhythmia monitoring, using wearable devices to measure tracing of the electrical activity of your heart, blood work, including genetic testing, and patient questionnaires

Institution
MUSC
Recruitment Contact
Sam Moody
843-876-9558
moodysa@musc.edu

Enhancing evidence generation by linking randomized clinical trials (RCTs) to real world data (RWD) – Linkage of DELIVER trial participants to their observational data.

Date Added
December 20th, 2023
PRO Number
Pro00129708
Researcher
Sheldon Litwin

List of Studies


Keywords
Drug Studies, Heart
Summary

The study will aim to link data collected during the DELIVER Randomized Contolled Trial (RCT) to Real World Data (RWD) during the 10 year period following subject participation in the clinical trial. Only individuals who participated in the DELIVER clinical trial will be approached to participate in this research. The study team will need to collect some of the subject's personal health identifiers. A research team at Brigham and Women's Hospital, the coordinating center for the DELIVER Trial, will then use the subject's personal identifiers to obtain data from subjects' health insurance and/or hospital systems.

Institution
MUSC
Recruitment Contact
Renee Baxley
8437921105
baxleyr@musc.edu

CORD clamping among neonates with Congenital Heart Disease

Date Added
December 11th, 2023
PRO Number
Pro00131976
Researcher
Sinai Zyblewski

List of Studies


Keywords
Heart, Pediatrics, Pregnancy
Summary

A randomized clinical trial study that compares 2 different timepoints to clamp the cord at birth. The study involves babies with heart disease born between 37 0/7- 41 6/7 weeks of pregnancy. Doctors will clamp the umbilical cord around 30 seconds (between 1-<60 seconds) after birth vs. around 120 seconds (between 60-<180 seconds) after birth. Doctors consider both treatment groups to be "usual care." A goal of this study is to find out which umbilical cord clamping timepoint is best for babies with heart disease.

Institution
MUSC
Recruitment Contact
Layla Al Sarraf
843-901-4153
alsarral@musc.edu

A randomized, sham-controLled, clinical Trial For evaLuation Of the EdWards APTURE transcatheter shunt system (ALT-FLOW II)

Date Added
November 28th, 2023
PRO Number
Pro00132875
Researcher
Brian Houston

List of Studies


Keywords
Heart, Hypertension/ High Blood Pressure
Summary

This is a study to evalaute the device's safety, function, and effects on heart function, and clinical outcomes of using the Edwards APTURE system (study device) in subjects with heart failure.

Major study activities include 3 right heart catheterizations (RHC) with exercise, a computed tomography (CT) scan with contrast, multiple ultrasounds of the heart, labs, and other assessments. The length of subject participation in the study is 5 years and includes 11 research visits.

The information obtained from this study will show how safe and effective this approach is in treating the symptoms of heart failure. Alternative treatment for heart failure depends on the cause, but may include diet and exercise, managing stress, medication (such as medications to treat leg swelling, high blood pressure, or abnormal heart rate), participation in another research study or continuing with current medical therapy

Institution
MUSC
Recruitment Contact
Shaquanda Ross-Simmons
843-876-5783
shr37@musc.edu



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