A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY ON THE SAFETY AND EFFICACY OF ISTAROXIME FOR PRE-CARDIOGENIC SHOCK (SEISMiC)

Date Added
June 22nd, 2021
PRO Number
Pro00107597
Researcher
Adrian Van Bakel

List of Studies


Keywords
Drug Studies, Heart
Summary

This study is for patients who are currently hospitalized with heart failure, a condition where the heart muscle is weakened and cannot pump blood effectively, and have low blood pressure. This study involves an investigational, not yet approved by the US Food and Drug Administration (FDA) intravenous (given into a vein) medication that is being studied to see if it can help increase blood pressure. The study involves a screening visit, randomization which is where either the study medication or placebo is assigned randomly, medication or placebo infusion for 24 hours, visits at day 2,3 and 4 and then a final visit at day 30.

Institution
MUSC
Recruitment Contact
Kavin Panneerselvam
843-792-0464
panneeer@musc.edu

BATwire - Percutaneous Implant Kit

Date Added
June 8th, 2021
PRO Number
Pro00107572
Researcher
Jean Ruddy

List of Studies


Keywords
Heart, Surgery
Summary

Potential participants are people who have been on medications to treat heart failure, but you continue to have symptoms and qualify to have the FDA approved BAROSTIM NEO™ System implanted. The purpose of this research study is to describe the safety and effectiveness of the delivery system by an ultrasound guided implant procedure in people with heart failure. This is an experimental implant procedure where the data collected during and after procedure will help confirm the safety and effectiveness of the new implant procedure. This will be the first time humans will be implanted using this experimental procedure.

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

A Phase 3 Global, Double-Blind, Randomized, Placebo‑Controlled Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Transthyretin‑Mediated Amyloid Cardiomyopathy (ATTR CM)

Date Added
June 8th, 2021
PRO Number
Pro00110317
Researcher
Daniel Judge

List of Studies


Keywords
Cardiovascular, Heart
Summary

The purpose of this study is to evaluate the safety and effectiveness of ION-682884 and determine if it can help people with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) which is a disease caused by change in a protein called transthyretin (TTR). ION-682884 is an investigational drug. "Investigational" means that ION-682884 is not yet approved for use in any settings outside of clinical research studies like this one and is considered experimental. ION-682884 has been shown to reduce the level of TTR in the blood of animals and healthy volunteers tested to date. Reducing the amount of TTR in your blood may reduce the amount of amyloid deposits in your body and may keep your cardiomyopathy from getting worse over time. However, it is not known if ION-682884 will help your cardiomyopathy.

If you meet the requirements and agree to participate in this study, you will receive subcutaneous (under the skin) injections of either ION-682884 or placebo once every 4 weeks from week 1 through week 117.
Your participation in this study will last approximately 36 months and will consist of clinic visits and follow up visits at home.

Institution
MUSC
Recruitment Contact
Hannia Ramos
843-876-4806
ramosha@musc.edu

Implantation of the HeartMate 3 in Subjects with Heart Failure using Surgical Techniques Other Than Full Median Sternotomy

Date Added
May 25th, 2021
PRO Number
Pro00107646
Researcher
Lucas Witer

List of Studies

Keywords
Cardiovascular, Heart
Summary

This study is looking for volunteers who are having the Heart Mate 3 (HM3) Left Ventricular Assist Device (LVAD) implanted for treatment of heart failure. The study will collect medical information and patient experiences who have received treatment with the HM3. The traditional method to implant the HM3 is an incision in the middle of the chest through the breastbone (also called the sternum). This study will collect data if you have the Heartmate 3 implanted using a less invasive approach. Study participants will attend 8 visits over the course of 6 months.

Institution
MUSC
Recruitment Contact
Caitlin Schaffner
843-792-7558
schaffne@musc.edu

Assessment of myocardial Damage and Encephalopathy by Repeated Trauma (ALERT)

Date Added
May 18th, 2021
PRO Number
Pro00109049
Researcher
Federica del Monte

List of Studies


Keywords
Brain, Dementia, Genetics, Heart
Summary

Two groups of former athletes (who competed in contact and not-contact sports) will undergo brain and heart assessments. Additionally, blood and urines samples will be collected in order to investigate potential markers of disease.

Institution
MUSC
Recruitment Contact
Gianlorenzo Daniele
(843) 442-6981
daniele@musc.edu

A Phase 2 Proof of Concept, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy of ASP1128 (MA-0217) in Subjects at Risk for Acute Kidney Injury following Coronary Artery Bypass Graft (CABG) and/or Valve Surgery

Date Added
April 21st, 2021
PRO Number
Pro00106141
Researcher
Sanford Zeigler

List of Studies


Keywords
Cardiovascular, Diabetes, Heart, Kidney, Surgery
Summary

The goal of this study is to find out if an investigational drug called ASP1128 (also called as MA-0217) is effective and safe as a treatment to prevent acute kidney injury (AKI) and/or reduce its severity in people who are at risk for AKI after heart surgery when compared to placebo (inactive substance). Researchers will look at how ASP1128 can act in the body.

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

The Impact of Low Flow Nocturnal Oxygen Therapy on Hospital Admissions and Mortality in Patients with Heart Failure and Central Sleep Apnea (LOFT-HF)

Date Added
March 25th, 2021
PRO Number
Pro00102395
Researcher
Chitra Lal

List of Studies


Keywords
Heart, Sleep Disorders
Summary

Central sleep apnea occurs when the brain fails to send a signal to the muscles that control breathing during sleep causing brief pauses in breathing. It is widely believed that treatment of central sleep apnea may improve heart failure and quality of life. The goal of this study is to evaluate the effectiveness of oxygen treatment in patients with both central sleep apnea and heart failure.

Institution
MUSC
Recruitment Contact
Andrew Stephens
8437923162
chamberam@musc.edu

Atellica® VTLi hs cTnI Assay Emergency Department Clinical Study Protocol

Date Added
February 11th, 2021
PRO Number
Pro00105432
Researcher
Gary Headden

List of Studies


Keywords
Heart
Summary

The purpose of this study is to use an investigational device called the Atellica® VTLi™ test system to test a substance in your blood called troponin that may help with the diagnosis of a heart attack

Institution
MUSC
Recruitment Contact
Aja Bayo
843-792-7944
bayo@musc.edu

Randomized Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients who Present with Symptomatic Heart Failure with Reduced Ejection Fraction (HFrEF)

Date Added
February 9th, 2021
PRO Number
Pro00104312
Researcher
Daniel Steinberg

List of Studies


Keywords
Heart, Surgery
Summary

This study is being done on patients who have heart failure, a condition where the heart muscle weakens and enlarges and cannot pump blood effectively. The purpose of this study is to assess the safety and effectiveness of a new device called the AccuCinch Ventricular Restoration System and compare it to treatment with standard heart failure medications alone. The AccuCinch Ventricular Restoration System consists of anchors, which attach to your heart muscle, sliders to connect the anchors and a thread like cord that goes through the anchors and is cinched to make your enlarged heart smaller so it can pump more efficiently. The device is implanted in one of the lower pumping chambers of the heart (called left ventricle). The study will have two groups, the treatment group in which participants undergo the device implant in addition to taking heart failure medications and the control group in which participants are treated with heart failure medications alone. Participation will last up to 5 years.

Institution
MUSC
Recruitment Contact
Kavin Panneerselvam
843-792-0464
panneeer@musc.edu

AcQMap® US Registry of Procedural and Long-term Clinical Outcomes (Discover-US)

Date Added
January 22nd, 2021
PRO Number
Pro00104331
Researcher
Jeffrey Winterfield

List of Studies


Keywords
Heart
Summary

This study is collecting data on patients who are having an ablation procedure to correct an irregular heart beat called an arrhythmia. During this procedure an electrical map is made so your doctor can see where the irregular signals are located in your heart. The electrical mapping system called AcQMap®. After creating the electrical map your doctor will perform an ablation, which is a procedure where the irregular signals are burned with an ablation catheter. The catheter, a long, thin tube that enters at an artery in your groin area and is directed to your heart. The end of the catheter is able to burn tissue on contact. Your physician will use this catheter to burn the areas in your heart where the irregular heart beats start. This study will collect data from just before your ablation up to 3 years.

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



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