The clinical trials groups within the Division of Cardiology bridge the realm of bench science with that of daily clinical care rendered to patients within our healthcare system. Through clinical trials, its investigators and trials staff provide the mechanism for the collection of data to determine the efficacy and safety of new pharmaceuticals and devices. Trial recruitment and management is critical to the success of the program, and relies heavily on the independent work of study coordinators. Ethical considerations must be paramount, as our first priority is patient safety – therefore there are significant regulatory requirements (internal to the university, as well as to numerous external agencies).
There are two distinct groups managing clinical trials within the Division of Cardiology – the heart failure group and the cardiology clinical trials group. In addition, several faculty members’ work on investigator initiated research, employing clinical and administrative staff, interns, and work study students to assist. The cardiology clinical trials group manages a complex array of industry-sponsored, federally-funded, and investigator-initiated trials across the various disciplines within cardiology, including cardiac electrophysiology, interventional cardiology, advanced heart failure, and general cardiology. Provided below is a listing of the current clinical trials run through the cardiology clinical trials and heart failure groups.
For additional information on ongoing clinical research in the Division of Cardiology, please contact firstname.lastname@example.org (for cardiology clinical trials group) or Amanda Lee (for Adams heart failure group).
Cardiology Clinical Trials Group Studies by Subspecialty
- NAVIGATE X4 – Evaluation of ACUITY™ X4 Quadripolar Coronary Venous Leads and RELIANCE™ 4-FRONT Defibrillation Leads
- PREEMPT-HF – An observational study designed to collect device and clinical event data to evaluate extended applications of the HeartLogicTM Heart Failure Diagnostic (HeartLogic) in a broad spectrum of heart failure (HF) patients with an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D).
- QP ExCELs – Sentus QP – Extended CRT evaluation with Quadripolar Left Ventricular Leads
- Heart Failure Optimization Study – An observational study designed to observe the rate of ejection fraction recovery while being optimized on guideline directed medical therapy (GDMT) during the 90-180 day period using the LifeVest to provide protection against sudden death.
- MINT – The purpose of this study is to compare two red blood cell transfusion strategies (liberal and restrictive) for patients who have had an acute myocardial infarction and are anemic
- PARADISE-MI – Prospective ARNI versus ACE inhibitor trial to determine superiority in reducing heart failure events after myocardial infarction
- SERENADE – This is a study to evaluate whether macitentan is an effective and safe treatment for patients with heart failure with preserved ejection fraction (HFpEF) and pulmonary vascular disease
- ECLIPSE – A trial to evaluate Orbital Atherectomy compared to conventional balloon angioplasty technique for the treatment of severely calcified lesions prior to implantation of drug-eluting stents (DES)
- RADIANCE HTN – A randomized, double-blind, sham controlled, 2-cohort study (TRIO and SOLO) designed to demonstrate efficacy and document the safety of the Paradise Renal Denervation System in two distinct populations of hypertensive subjects
- RADIANCE II – A pivotal study designed to demonstrate the effectiveness and safety of the Paradise System in subjects with Stage 2 hypertension on 0-2 medications at the time of consent.
- AMPLATZER PIVSD Occluder PAS – Post approval study to evaluate the safety and probable benefit of the AMPLATZER™ PIVSD Occluder
- CARILLON – A multi-center, randomized, double-blind trial is to assess the safety and efficacy of the CARILLON Mitral Contour System in treating subjects with functional mitral regurgitation (FMR) associated with heart failure
- PORTICO – Portico™ Re-sheathable Transcatheter Aortic Valve System US IDE Trial
Advanced Heart Failure and Transplantation
- ATTRibute-CM – A Phase 3, randomized, double-blind, placebo-controlled study of the efficacy and safety of AG10 in subjects with symptomatic transthyretin amyloid cardiomyopathy
- INTELLECT 2-HF – An observational post market study intended to characterize hemodynamic-guided management (using CardioMEMS) of patients with an existing left ventricular assist device (LVAD) to protocol specified target ranges and its impact on functional status, quality of life, and readmissions
- MOMENTUM 3 IDE Study – Multicenter Study of MagLev Technology in Patients Undergoing MCS Therapy with HeartMate3™
- MOMENTUM 3 CAP – Multi-Center Study of MagLev Technology in Patients Undergoing MCS Therapy with HeartMate3™ Continued Access Protocol
- SSI Registry – Driveline Silicone Skin Interface Registry Protocol
Adams Heart Failure Research Group Clinical Trials
- GALACTIC-HF – A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Omecamtiv Mecarbil on Mortality and Morbidity in Subjects With Chronic Heart Failure With Reduced Ejection Fraction
- VICTORIA – A Randomized Parallel-Group, Placebo-Controlled, Double-Blind, Event- Driven, Multi-Center Pivotal Phase III Clinical Outcome Trial of Efficacy and Safety of the Oral sGC Stimulator Vericiguat in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF) – VerICiguaT Global Study in Subjects With Heart Failure With Reduced Ejection Fraction
- PIONEER-HF – A multicenter, randomized, double-blind, double dummy, parallel group, active-controlled 8-week study to evaluate the effect of sacubitril/valsartan (LCZ696) versus enalapril on changes in NT-proBNP and safety and tolerability of in-hospital initiation of LCZ696 compared to enalapril in HFrEF patients who have been stabilized following hospitalization for acute decompensated heart failure (ADHF)
- TROUPER – Tolvaptan For Worsening Outpatient Heart Failure: Role of Copeptin In Identifying Responders