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Clinical Studies

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  • Characterizing Left and Right Ventricular Function in Relation to Exercise Capacity in Breast Cancer Survivors Jacksonville, Fla.

    The purpose of this study is to determine if exercise improves cardiac remodeling as a way to mitigate the negative effects of chemotherapy and radiation therapy which lead to reduced exercise tolerance.

  • Diagnostic Utility of Exercise Cardiac Magnetic Resonance in the Assessment of Cardiac Dyspnea Jacksonville, Fla.

    The purpose of this study is to assess cardiac dyspnea using exercise cardiac magnetic resonance as a diagnostic tool.

  • Exercise Cardiac Magnetic Resonance Imaging May Characterize Early Changes of Pulmonary Artery Hypertension Jacksonville, Fla.

    The purpose of this study is to evaluate the diagnostic benefit of adding exercise to cardiac Magnetic Resonance Imaging to help show early changes that may assist in the earlier diagnosis of Pulmonary Artery Hypertension.

  • Hypertension and Development of Coronary Artery Disease in Master Athletes Jacksonville, Fla.

    The purpose of this study is to determine association of exercised-induced systolic blood pressure and development of coronary artery disease in master athletes and compare them to a group of masters athletes without coronary artery disease.

  • Phase 2 Multicenter, Double-Blind, Placebo Controlled, Efficacy, Safety, and Pharmacokinetic Study of 2 Doses of CXA-10 on Stable Background Therapy in Subjects With Pulmonary Arterial Hypertension (PAH) Jacksonville, Fla.

    The purpose of this study is to evaluate the safety, effectiveness and pharmacokinetics of 2 doses of CXA-10 on stable background therapy in 96 subjects 18 to 80 years of age with pulmonary arterial hypertension (PAH).

  • Role of the Gut Microbiome in Pulmonary Hypertension Jacksonville, Fla.

    Pulmonary hypertension (PH) is a progressive, symptomatic, and ultimately fatal disorder for which there are no effective therapies. Resident gut microbiota are now recognized as potent modifiers of the host immune responses in various pathologies. Evidence from animal studies suggest that the microbial composition is altered in lung diseases such as asthma, chronic obstructive pulmonary disorders (COPD) and cystic fibrosis. Our goal in this study will be to determine and compare the gut microbial composition between healthy individuals and pulmonary hypertensive patients.

     

     

     

     

     

  • Sulzbacher Cardiovascular Research Protocol Jacksonville, Fla.

    The purpose of this study is to determine the effectiveness of intensive, guideline-directed, preventative therapies on cardiovascular disease in the homeless population to help develop an appropriate care model for preventing and treating CVD in the homeless.

     


     

  • Sulzbacher Pill Box Initiative For Hypertensive Management Jacksonville, Fla.

    Hypertension (HTN) is the leading cause of cardiovascular diseases worldwide and is highly modifiable using pharmacologic and nonpharmacologic therapies.  Results from the Systolic Blood Pressure Intervention Trial (SPRINT) suggest that intensive blood pressure control to <120/80 vs. <140/90 is associated with reduced cardiovascular events and death for patients with high cardiovascular disease risk.  However, less than 50% of Americans achieve even marginal blood pressure control <140/90.  The prevalence of uncontrolled hypertension is even higher in the homeless population, which suffers from limited access to healthcare, poor nutrition, chronic stress, substance abuse and lack of consistent medication adherence.  Additional outreach support may be necessary to improve blood pressure (BP) control and reduce cardiovascular risk in this vulnerable population.  

    The purpose of this project is to improve blood pressure control among a cohort of homeless and underserved patients over a 6 month period. Our target group is already participating in the Sulzbacher Center's protocol with the National Hypertension Control Initiative (NHCI), an evidence-based community program with the goal to reduce high blood pressure, in under-resourced neighborhoods.  We aim to enhance patient education on HTN and enroll eligible patients in an additional pillbox initiative to improve medication adherence.  The protocol will be as follows: 

    Adult patients (aged > 18 years) with hypertension, who receive primary care and cardiovascular care through the Sulzbacher Clinic in Jacksonville, FL will be eligible for participation. Participants will be screened for hypertension during regular vital sign checks in clinic triage.  Patients with known hypertension on BP medications and those found to have hypertension (BP > 130/80) during triage will be educated on the details of the study and the risks and benefits of enrollment. Patients will be given oral informed consent, which will highlight that there is no financial benefit for enrollment and that participants may withdraw from the study at any point.    Patients who offer oral informed consent will be enrolled.  

    Following enrollment, patients will receive a BP cuff and be instructed on how to use it, as is already being copmleted as part of the Sulzbacher's NHCI protocol. They will be asked to keep a BP log and to bring their log to follow-up visits. They will be prescribed antihypertensives as indicated by routine clinical care.  Pharmacological management of hypertension will be made per the discretion of the visit provider (Sulzbacher and/or Mayo Clinic advance practice provider or physician).  For the current study, BP medications will then be placed in a 1 month pill box on the day of enrollment and refilled at each subsequent visit.  Compliance will be measured by pill counts remaining in their box at each follow-up visit and self-reported adherence at follow-up. Follow-up visits will be conducted as dictated by routine medical care, and prescription refills with pill box will be supplied monthly in person.  Patients will be educated on pharmacological and nonpharmacological therapies for BP management by research staff and the visit provider.  

    The primary outcomes measured will be medication compliance and percentage of patients with hypertension control at 1 month and 6 months.  We aim to improve compliance by 10% and to improve the percentage of patients with BP < 130/80 by more than 10% above baseline.  

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