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

Molecular links between Alzheimer's Disease and Cardiomyopathy

Date Added
June 16th, 2020
PRO Number
Pro00071077
Researcher
Federica del Monte

List of Studies

Keywords
Alzheimers, Dementia, Genetics, Heart
Summary

Patients with Alzheimer Disease and patients with Heart failure (and a control group free from both the previous mentioned conditions) will be evaluated with cardiac and neuropsychological assessments, in order to investigate the relationship between the two conditions. 8 follow up visits will be repeated yearly, for 8 years.

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

The Nanowear Wearable Heart Failure Management System Multiple Sensor Algorithm Development and Validation Trial (NanoSense)

Date Added
April 28th, 2020
PRO Number
Pro00098518
Researcher
Adrian Van Bakel

List of Studies

Keywords
Heart, Hypertension/ High Blood Pressure
Summary

This study is being done to find out if we can better monitor subjects with heart failure with the use of a wearable device (called SimpleSense garment) that can monitor multiple factors of heart failure that affect the body such as heart rate, activity, heart rhythm, and respiratory rate. Participants will wear the SimpleSense garment for 90 days for at least 12 hours daily. Participation in the study will include two research clinic visits and 2 phone calls over 4 months. Participants will be compensated for time and travel.

Risks of this study include loss of confidentiality, blood draw and skin irritation from wearing the garment.

Institution
MUSC
Recruitment Contact
Jacques Johnson
843-876-5873
johnjacq@musc.edu

Design and Rationale of the assessment of the Mindmics recording system to collect data to facilitate the development of an algorithm to discriminate atrial fibrillation from sinus rhythm

Date Added
March 24th, 2020
PRO Number
Pro00096535
Researcher
Francis Gilliam

List of Studies

Keywords
Cardiovascular, Heart
Summary

We will recruit patients with atrial fibrillation during office visits and at time of elective direct current cardioversions.

We will record 15 minutes of ECG data and data from the Mindmics earbuds during office visit or prior to and after cardioversion.

We will use the recorded data to formulate algorithms to discern atrial fibrillation from normal sinus rhythm.

Institution
Palmetto
Recruitment Contact
Francis Gilliam
8035531321
Rosey.gilliam@prismahealth.org

Clinical Study of the BioVentrix Revivent TC™ System for Treatment of Left Ventricular Aneurysms

Date Added
March 24th, 2020
PRO Number
Pro00096973
Researcher
Richard Bayer

List of Studies

Keywords
Cardiovascular, Heart
Summary

The Revivent TC System study is being conducted to test an investigational device that can repair a Left Ventricular Aneurysm without the use of a heart-lung machine, or opening the chest/heart chamber. The device works by placing a tuck in the heart where there is scar, which has the effect of shortening the distance across the heart and decreasing the tension, or stress, on the working heart muscle. The device consists of several implants, called anchors. The anchors are placed during a surgery in which your doctors will access your heart by placing a guide wire through a vein in your neck into your heart and also through an incision in your chest wall between your ribs on your left side. The anchors will help reshape your heart muscle by tucking in the scarred area. It is expected that the total study duration will be approximately 6 years, consisting of 1 year of patient enrollment and 5 years of patient follow-up.

Institution
MUSC
Recruitment Contact
Deborah Everidge
8437922244
adamsde@musc.edu

Peri-operative Exposure to Plasticizers in Newborns Undergoing Cardiac Surgery

Date Added
March 18th, 2020
PRO Number
Pro00087955
Researcher
Eric Graham

List of Studies

Keywords
Heart, Surgery
Summary

This is a prospective observational study which collects urine samples for testing. The goal of this study is to measure how much plastic from medical equipment shows up in the baby's urine.

Institution
MUSC
Recruitment Contact
Kalyan Chundru
843-792-1213
choudhar@musc.edu

A Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal, Parallel Group Study of Patiromer for the Management of Hyperkalemia in Subjects Receiving Renin-Angiotensin-Aldosterone System Inhibitor (RAASi) Medications for the Treatment of Heart Failure (DIAMOND)

Date Added
February 28th, 2020
PRO Number
Pro00097945
Researcher
Priya Kumar

List of Studies

Keywords
Heart
Summary

Prospective Phase 3b multinational, multicenter, double-blind, placebo-controlled,
randomized withdrawal, parallel group study that includes Screening and 12 weeks Run-in Phase (all subjects will have patiromer initiated and RAASi medications, including mineralocorticoid receptor antagonist (MRA), optimized) and a randomized withdrawal Blinded Treatment Phase.

Institution
Self Regional
Recruitment Contact
Alicia Shirley
864-943-2416
alicia.bryan-shirley@selfmedicalgroup.org

GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients with Patent Foramen Ovale (PFO): the REDUCE Post Approval Study

Date Added
February 25th, 2020
PRO Number
Pro00095864
Researcher
John Rhodes

List of Studies

Keywords
Heart
Summary

REDUCE study is researching the safety and effectiveness of GORE® CARDIOFORM Septal Occluder (GSO ) device in closing the patent foramen ovale (PFO) in patients who have a PFO and had a stroke of unknown origin (cryptogenic stroke). This device has been approved by the United States Food and Drug Administration for this indication.

A PFO is a common opening in the wall (septum) between the two upper chambers (the right and left atria) of the heart. In most cases, this opening closes around the time of birth. If the opening remains after birth, it can allow the blood to mix in the two upper chambers of the heart.

In most people, leaving the opening untreated has no negative consequences. However, in some patients who have had a stroke of unknown origin (cryptogenic stroke), the presence of a PFO may increase the risk of having another stroke if the opening is left untreated.

Institution
MUSC
Recruitment Contact
Kalyan Chundru
843-792-1213
choudhar@musc.edu

PIVOTAL EVALUATION OF THE ACCESS NATRIURETIC PEPTIDE ASSAY(S) AS AN AID IN THE DIAGNOSIS AND ASSESSMENT OF SEVERITY OF ACUTE HEART FAILURE – EMERGENCY DEPARTMENT SUBJECT ENROLLMENT AND SPECIMEN COLLECTION

Date Added
February 17th, 2020
PRO Number
Pro00095805
Researcher
Gary Headden

List of Studies

Keywords
Cardiovascular, Heart
Summary

This is a prospective, multicenter clinical trial for individuals presenting to the Emergency Department with suspicion of acute heart failure. A blood sample collected will be used to compare the standard of care BNP test used at the local site to the investigational assay from Beckman Coulter (sponsor).

The diagnosis and treatment of patients at each site will use an FDA-cleared BNP or NT-proBNP assay under the site's standard of care and NOT the investigational assay.

Institution
MUSC
Recruitment Contact
Annelise Kauffman
843-792-3576
kauffmaa@musc.edu

A Multi-Institutional Neurocognitive Discovery Study (MINDS) in Adult Congenital Heart Disease (ACHD): MINDS-ACHD

Date Added
January 16th, 2020
PRO Number
Pro00085138
Researcher
John Rhodes

List of Studies

Keywords
Heart
Summary

This is a multicenter cross-sectional pilot analysis of objective and subjective neurocognitive deficits (NCD) and genetics in the Adults with Congenital Heart Disease (ACHD) population ages 18-30 years with moderate and severe complexity of congenital heart disease (CHD).

The expectation is that studying NCD in ACHD will help to guide access to resources and appropriate medical care for these patients. This research should facilitate the use of targeted interventions in the ACHD population with NCD to enhance both long term quality of care and quality of life (QOL).

Institution
MUSC
Recruitment Contact
Kalyan Chundru
843-792-1213
choudhar@musc.edu



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