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, 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, structural heart disease, 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
- DARE-19 – This is an international, multicenter, parallel-group, randomized, double-blind, placebo controlled, study in hospitalized adult patients with COVID-19 in the US and other countries with high prevalence of COVID-19. The study is evaluating the effect of dapagliflozin 10 mg versus placebo, given once daily for 30 days in addition to background local standard of care therapy, in reducing disease progression, complications, and all-cause mortality
- 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)
- AEGIS II – This is a phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of CSL112 on reducing the risk of major adverse CV events in subjects with acute coronary syndrome (ACS) diagnosed with either ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI), including those managed with percutaneous coronary intervention (PCI) or medically managed
- cvMOBIUS – This is a North American registry of patients with atherosclerotic cardiovascular disease (ASCVD) aimed at understanding patterns of care in ASCVD while evaluating the real world effectiveness of PCSK9 inhibition
- 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
- VESALIUS-CV – This study will assess the effect of lowering low-density lipoprotein cholesterol (LDL-C) with evolocumab on major cardiovascular events in adults without a prior myocardial infarction (MI) or stroke who are at high risk of a cardiovascular event
- 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)
- ILUMIEN IV – The objective of this clinical investigation is to demonstrate the superiority of an Optical Coherence Tomography (OCT)-guided stent implantation strategy as compared to an angiography-guided stent implantation strategy in achieving larger post-PCI lumen dimensions and improving clinical cardiovascular outcomes in patients with high-risk clinical characteristics and/or with high-risk angiographic lesions.
- 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
- ACURATE IDE – A multi-center, randomized trial to evaluate safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for transcatheter aortic valve replacement (TAVR) in subjects with severe native aortic stenosis who are indicated for TAVR
- 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
- ARIES HM3 – This is a prospective, randomized, double-blinded, placebo-controlled clinical investigation of advanced heart failure patients treated with the HM3 with two different antithrombotic regimens: vitamin K antagonist with aspirin versus vitamin K antagonist with placebo
- 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
- CARDIO-TTRansform – This is a multicenter, double-blind trial to evaluate the efficacy of AKCEA-TTR-LRx compared to placebo for 120 weeks in patients with ATTR-CM receiving available standard of care (SoC).
- MOMENTUM 3 CAP – Multi-Center Study of MagLev Technology in Patients Undergoing MCS Therapy with HeartMate3™ Continued Access Protocol
- MOMENTUM 3 Post Approval Study – This study will be a prospective, multi-center, non-blinded, controlled study, intended to evaluate the extended use of the HM3 LVAS compared to the HMII LVAS in those patients that are ongoing at the 2-year follow-up in the MOMENTUM 3 IDE trial
- SHORE – This is an observational registry to assess the clinical utility of surveillance using HeartCare testing services, in association with clinical care of heart transplant recipients
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