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Research & Clinical Trials

Active Research Studies

The Dr. Kiran C. Patel Research Institute oversees dozens of research studies every year across many clinical disciplines. Patients that are admitted to our hospitals who meet specific criteria for studies may be asked to participate in a research study, but are never obligated to.

If you are interested in participating in one of our trials, you will need to complete a Release of Information form.

Following is a list of research studies that are currently active at our hospital. For more information about all the research that has been conducted at Florida Hospital Pepin, please click here.

APPRAISE ATP: Assessment of Primary Prevention Patients Receiving An ICD - Systematic Evaluation of ATP

The objective is to understand the role of anti-tachycardia pacing (ATP) in primary prevention patients indicated for ICD therapy and programmed according to current guidance of higher rate cut-offs and therapy delays. The time to first all-cause shock will be tested in subjects with standard therapy (ATP and shocks) compared to subjects programmed to shock only to assess equivalency. Identifier: NCT02923726

Lead: Poliana Ayala -

CONNECT-HF: Care Optimization through Patient and Hospital Engagement Clinical Trial for Heart Failure

Connect-HF is a hospital based quality improvement trial comparing two QI initiatives to standard care on heart failure outcomes (readmissions or all-cause mortality) and HF quality of care metrics at 1 year after discharge for participants hospitalized with acute HF and reduced ejection fraction. Identifier: NCT03035474

Lead: Marissa Hardy –

CONTROL HTN-02:  A Prospective, Randomized, Adaptive, Double-Blind, Sham-Controlled, Multicenter Study to Evaluate the ROX Coupler in Subjects with Hypertension

Evaluate the safety and effectiveness of the ROX Coupler used to create an arteriovenous anastomosis in the iliac region (between the iliac artery and vein) in subjects with hypertension. Identifier: NCT02895386

Lead: Juliet Bala –

DREAM HF-1: Efficacy and Safety of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) for the Treatment of Heart Failure.

The primary objective of this study is to determine whether trans-endocardial delivery of allogeneic human bone marrow-derived MPCs (CEP-41750) is effective in the treatment of chronic heart failure due to LV systolic dysfunction.  A Double-blind, Randomized, Sham-procedure-controlled, Parallel-group Efficacy and Safety Study of Allogeneic Mesenchymal Precursor Cells (CEP-41750) in Patients with Chronic Heart Failure Due to Left Ventricular Systolic Dysfunction of Either Ischemic or Nonischemic Etiology. Identifier: NCT02032004                    

Lead: Betsy Szymanski –

GALACTIC-HF:  Registrational Study With Omecamtiv Mecarbil/AMG 423 to Treat Chronic Heart Failure With Reduced Ejection Fraction AMGEN CHF

The purpose of this study is to determine if treatment with omecamtiv mecarbil/AMG 423 when added to standard of care is well tolerated and superior to placebo in reducing the risk of cardiovascular death or heart failure events in subjects with chronic HFrEF. Identifier: NCT02929329

Lead:  Betsy Szymanski –

PIONEER-HF: Comparison of Saocubitril/valsartaN Versus Enalapril on Effect on ntpRo-bnp in Patients Stabilized From an Acute Heart Failure Episode

The purpose of this study is to assess the effect of in-hospital initiation of sacubitril/valsartan (LCZ696) vs. enalapril on time averaged proportional change in NT-proBNP in patients who have been stabilized following hospitalization for acute decompensated heart failure (ADHF) and reduced ejection fraction (left ventricular ejection fraction (LVEF) ≤ 40%). Identifier: NCT02554890

Lead: Betsy Szymanski –

PLEXA:  Master Study of the Ilivia ICD Family and the Plexa ICD Lead

This is a post-market registry study designed to confirm the long-term safety and reliability of the Plexa lead used with a BIOTRONIK ICD or CRT-D device. Identifier: NCT02774616

Lead: Cynthia Paysor –

PRIME HF: Pre-discharge Initiation of Ivabradine in the Management of Heart Failure

Subjects will be randomized 1:1 to pre-discharge initiation of Ivabradine versus standard care (I.E. post-discharge initiation of Ivabradine at the discretion of the physician). The hypothesis is that, compared with usual care, a treatment strategy of initiation of Ivabradine prior to discharge for a hospitalization for acute heart failure will be associated with a greater proportion of participants using Ivabradine at 180 days. Identifier: NCT02827500                                                                                   

Lead: Betsy Szymanski –

QP EXCELS: Sentus QP-Extended CRT Evaluation With Quadripolar Left Ventricular Leads:

The QP ExCELs study is designed to confirm safety & efficacy of the BIOTRONIK left ventricular leads Sentus OTW QP L & Sentus OTW QP S to satisfy FDA requirements for regulatory approval of the leads in the US.  Long-term safety of the Sentus OTW QP L and Sentus OTW QP S lead will be confirmed during a post approval phase (US sites only). Identifier: NCT02290028                    

Lead: Cynthia Paysor –