Key informant interviews to facilitate development of adherence tools in solid organ transplant Save

Date Added
March 15th, 2018
PRO Number
Pro00075735
Researcher
Nicole Pilch

Silhouette
Keywords
Heart, Kidney, Liver, Lung, Non-interventional, Transplant
Summary

A sample of patients will be drawn from a cross-sectional cohort of pre- and post-abdominal and cardiothoracic transplant recipients from March 2018 through May 2018. 10 to 15 minute key informant interviews will be conducted with patients to ascertain their views and perceptions related to adherence pre- and post-transplant and use of technolgy. This data will be used to educate the transplant community about adherence from the patient's perspective.

Institution
MUSC
Recruitment Contact
Nicole Pilch
843-792-3702
weimert@musc.edu

Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in Non-responders and Previously Untreatable Patients Save

Date Added
February 13th, 2018
PRO Number
Pro00074653
Researcher
John Sturdivant

Silhouette
Keywords
Cardiovascular, Heart
Summary

The purpose of the study is to test a new way to pace the left side of the heart without using pacing leads, using the WiSE CRT System. In this study, ultrasound will be used to transfer energy from a new type of pacemaker through your body to a special receiver that is placed inside the left ventricle of your heart. The receiver will use the ultrasound energy to pace the heart without using pacing leads.

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

Multi-Center Acute Safety Trial of TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for the Treatment of Drug Refractory Recurrent Symptomatic Paroxysmal Atrial Fibrillation Save

Date Added
February 13th, 2018
PRO Number
Pro00072452
Researcher
Jeffrey Winterfield

Silhouette
Keywords
Cardiovascular, Heart
Summary

The purpose of this research study is to collect information on the safety of the TactiCath SE ablation catheter when it is used to treat atrial fibrillation.This study will collect information about the success of the procedure and report on the number and type of follow-up problems that may occur during or after the ablation procedure (sometimes called adverse events). Data collected for this study will be submitted for review and approval by the FDA.

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

Assessment of Surrogate Sensors for Hypertension (ASSH) Study Save

Date Added
January 23rd, 2018
PRO Number
Pro00073998
Researcher
Thomas Todoran

Silhouette
Keywords
Heart, Hypertension/ High Blood Pressure
Summary

The purpose of this study is to collect measurements related to the body such as blood pressure, the amount of oxygen in the blood, and heart rhythm recordings. Findings from this study may be used to help design new device-based monitoring technologies in the future.

Continuous blood pressure readings will be obtained during standard of care heart catheterization procedures that include the use of an arterial blood pressure line. Continuous readings of oxygen saturation and ECG will also be obtained. Participants will consist of subjects aged ? 18 years who are scheduled to undergo a cath-lab (cath-lab, percutaneous coronary intervention or equivalent) procedure that includes the use of an arterial blood pressure line.

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

A phase III randomized, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure with preserved Ejection Fraction (HFpEF). Save

Date Added
January 3rd, 2018
PRO Number
Pro00065220
Researcher
Ryan Macnevin
Keywords
Cardiovascular, Coronary Artery Disease, Heart
Summary

The objective of this event-driven trial is to demonstrate superiority of empagliflozin 10 mg versus placebo in patients with symptomatic, chronic HF and preserved ejection fraction (LVEF > 40%) under stable treatment of HF symptoms.

Inclusion criteria:
?Male or female patient, age >= 18 years at screening.
?Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association classification) class II-IV and preserved EF (Ejection Fraction)(LVEF (Left Ventricular Ejection Fraction) > 40 %) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide) > 300 pg/ml for patients without AF, OR > 900 pg/ml for patients with AF, analysed at the Central laboratory at Visit 1
?Structural heart disease within 6 months prior to Visit 1, OR documented HHF (Hospitalisation for Heart Failure) within 12 months prior to Visit 1
?Stable dose of oral diuretics, if prescribed
?Signed and dated written ICF (informed consent form)
?Further inclusion criteria apply

Exclusion criteria:
?Myocardial infarction, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
?Heart transplant recipient or listed for heart transplant
?Acute decompensated HF (Heart Failure)
?Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
?Symptomatic hypotension and/or a SBP < 100 mmHg
?Indication of liver disease,
?Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration Equation))cr or requiring dialysis
?History of ketoacidosis
?Treatment with any SGLT (Sodium-glucose co-transporter) -2 inhibitor or combined SGLT-1 and 2 inhibitor
?Currently enrolled in another investigational device or drug trial
?Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
?Women who are pregnant, nursing, or who plan to become pregnant while in the trial
?Further exclusion criteria may apply

Institution
Palmetto
Recruitment Contact
Ryan MacNevin
803-434-3800
ClinicalTrialSurvey@PalmettoHealth.org

A Randomized Controlled Clinical Evaluation of the DiamondTemp™ System for the Treatment of Paroxysmal Atrial Fibrillation Save

Date Added
November 28th, 2017
PRO Number
Pro00072395
Researcher
John Wharton

Silhouette
Keywords
Cardiovascular, Heart
Summary

The purpose of this clinical study is to see whether a medical device called the DiamondTemp Ablation Catheter (also called the DiamondTemp Ablation System) can restore the heart to a normal heart rhythm.The DiamondTemp Ablation System being evaluated in this research study is investigational because it is not approved by the FDA for the treatment of atrial fibrillation by radiofrequency ablation. The DiamondTemp System is like systems currently being used to treat atrial fibrillation with radiofrequency ablation including the control system that participants could be randomized to.

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

Development of CSD-Based Therapies: Novel Indications and Improved Versions of CSD Save

Date Added
September 26th, 2017
PRO Number
Pro00069613
Researcher
Stanley Hoffman

Silhouette
Keywords
Heart, Lung, Lupus, Scleroderma
Summary

We have already observed that the blood cells known as monocytes from patients with the fibrotic disease scleroderma behave differently from monocytes from healthy controls. Here we will test whether patients with other fibrotic diseases also have altered monocyte function. Specifically, we will get blood from congestive heart failure and lupus patients and compare their monocytes to scleroderma patient and healthy subject monocytes. Our recent results in a mouse model for congestive heart failure suggest that we will find altered monocyte behavior in human congestive heart failure patients.

Institution
MUSC
Recruitment Contact
Elena Tourkina
843-792-7319
tourkine@musc.edu

A multi-center randomized, double-blind, active-controlled, parallel-group Phase 3 study to evaluate the efficacy and safety of LCZ696 compared to ramipril on morbidity and mortality in high risk patients following an acute myocardial infarction Save

Date Added
August 25th, 2017
PRO Number
Pro00065663
Researcher
Kurt Barringhaus
Keywords
Cardiovascular, Coronary Artery Disease, Heart
Summary

The purpose of this study is to test if LCZ696 taken twice a day, compared to ramipril taken twice a day, is safe and effective in reducing complications following an acute myocardial infarction (post-AMI), such as death from cardiovascular (CV) causes, hospitalization for heart failure (HF), or outpatient HF.

LCZ696 is a medicine which has been approved by the US Food and Drug Administration (FDA) for the treatment of people with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction. It has not been approved for treatment following a heart attack, the medical condition that you have. The medicine being tested in this study is not currently available for patients with your medical condition to receive a prescription for and/or to buy in any country. To date, over 21,000 subjects have taken LCZ696 in studies that have been performed in healthy subjects and patients with hypertension, heart failure with reduced ejection fraction, and heart failure with preserved ejection fraction.

The other medicine in this study, also called the comparator drug, is ramipril which is currently available on the market and approved for the treatment of patients with clinical signs of congestive heart failure post-AMI. Ramipril belongs to a class of medications called angiotensin-converting enzyme inhibitors, or ACE inhibitors (ACEIs), recommended as standard -of- care to treat the post-AMI patients.

Institution
Palmetto
Recruitment Contact
Kurt Barringhaus
803-434-3800
ClinicalTrialSurvey@PalmettoHealth.org

REVAMP Study (REmodeling the Left Ventricle with Atrial Modulated Pacing) Save

Date Added
August 8th, 2017
PRO Number
Pro00067879
Researcher
Sheldon Litwin

Silhouette
Keywords
Heart
Summary

The REVAMP Clinical Study is a feasibility study in heart failure with preserved ejection fraction (HFpEF) patients who have normal to small left ventricular volumes and evidence of hypertrophy. The pacemaker Sleep function will be used in order to deliver a 5 hour block of sustained pacing at 100 bpm during the night for 4-8 weeks. The purpose is to investigate whether this elevated pacing therapy is tolerated and whether there is a signal of efficacy.

If tolerated the idea is that this will promote LV dilation, which will reduce stiffness in the heart and improve diastolic filling in HFpEF patients that have thickened ventricular walls.

Institution
MUSC
Recruitment Contact
Kayla Moses
843-792-5873
moseska@musc.edu

Validation of the Palliative Performance Scale to predict survival of older adults admitted to the hospital from the Emergency Department. Save

Date Added
August 4th, 2017
PRO Number
Pro00063739
Researcher
Leigh Vaughan

Silhouette
Keywords
Cancer, Dementia, Heart, Kidney, Liver, Pulmonary, Stroke
Summary

The Palliative Performance Scale has been shown to predict survival among hospice and palliative medicine patients in the outpatient and inpatient clinical settings, where lower PPS scores are directly related to shorter survival. We seek to evaluate if this relationship persists among a racially diverse, older adult population when assessed at the time of admission from the emergency department.

Institution
MUSC
Recruitment Contact
Jonas Te Paske
8432597649
tepaske@musc.edu

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