A Quest for New, More Effective Treatments

The Cardiovascular Research Institute of Dallas [CRID] was established in 1992 by Dr. Martin Berk.  Over the years, CRID has been involved in numerous pharmaceutical and interventional research protocols that have helped to shape the practice of cardiovascular medicine in the areas of heart failure, atrial fibrillation, hypertension, anticoagulation, hyperlipidemia as well as cardiac and vascular interventional procedures and devices.

In addition to serving as clinical investigators on these trials, CIVA physicians share their knowledge of new devices, procedures and pharmaceuticals by lecturing around the world about both cardiac and peripheral vascular disease.

In addition to a dedicated team of clinical research staff, the institute has access to CIVA for support services including echocardiography, nuclear stress testing, CT angiography, Holter monitoring and laboratory services.

Ongoing and currently enrolling studies include:

National Institutes of Health [currently enrolling] CIRT: Cardiovascular Inflammation Reduction Trial:  A randomized, double-blind, placebo-controlled, event-driven trial of weekly low-dose methotrexate [LDM] in the prevention of cardiovascular events among stable coronary artery disease patients with type 2 diabetes or metabolic syndrome.

Novartis [subjects in follow up] CANTOS:  A randomized, double-blind, placebo-controlled, event-driven trial of quarterly subcutaneous canakinumab in the prevention of recurrent cardiovascular events among stable post-myocardial infarction patients with elevated hsCRP. 

Amylin Pharmaceuticals and AstraZeneca [subjects in follow up] EXSCEL:  A randomized, placebo controlled clinical trial to evaluate cardiovascular outcomes after treatment with Exenatide once weekly in patients with type 2 diabetes mellitus.

Sanofi [subjects in follow up] ODYSSEY:  A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the effect of SAR123553/REGN727 on the occurrence of cardiovascular events in patients who have recently experienced an acute coronary syndrome.

Boston Scientific [subjects in follow up] NAVIGATE X4:  Evaluation of ACUITYTM X4 Quadripolar Coronary Venous Leads and RELIANCETM 4-FRONT Defibrillation Leads.

Boston Scientific [subjects in follow up] S-ICD Post Approval Study

Heart Failure Trials

CVRx [currently enrolling] BeAT-HF: Barostim neo®:  Baroreflex Activation Therapy® for Heart Failure

Novartis [currently enrolling] PROVE-HF:  A 52-week, open label evaluation on the effects of sacubitril/valsartan [LCZ696] therapy on biomarkers, myocardial remodeling and patient-reported outcomes in heart failure with reduced left ventricular ejection fraction.

AstraZeneca [currently enrolling] D1699C00001:  Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients with Chronic Heart Failure with Reduced Ejection Fraction

Novartis [currently enrolling] PARAGON-HF:  A multicenter, randomized, double-blind, parallel group, active-controlled study to evaluate the efficacy and safety of LCZ696 compared to valsartan, on morbidity and mortality in heart failure patients [NYHA Class II-IV] with preserved ejection fraction.

Luitpold Pharmaceuticals [currently enrolling] 1VIT15043:  A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Injectafer® [Ferric Carboxymaltose] as Treatment for Heart Failure with Iron Deficiency.

Hypertension Trials

Boston Scientific [currently enrolling] REINFORCE: REDUCE HYPERTENSION:  Renal Denervation Using the Vessix Reduce TM Catheter and Vessix TM Generator for the Treatment of Hypertension.

High Cholesterol/High Triglyceride Trials

Regeneron Pharmaceuticals [currently enrolling] R727-CL-1532:  A randomized, double-blind, placebo-controlled study to evaluate the effect of Praluent on neurocognitive function in patients with heterozygous familial hypercholesterolemia or with non-familial hypercholesterolemia at high and very high cardiovascular risk.

Amarin [subjects in follow up] REDUCE-IT:  A multi-center, prospective, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the effect of AMR101 on cardiovascular health and mortality in hypertriglyceridemic patients with cardiovascular disease or at high risk for cardiovascular disease.

Peripheral Artery Disease Trials

Boston Scientific [currently enrolling] RANGER:  A 3:1 randomized trial comparing the Boston Scientific RANGERTM paclitaxel coated balloon vs standard balloon angioplasty for the treatment of superficial femoral arteries [SFA] and proximal popliteal arteries [PPA].

Boston Scientific [subjects in follow up] IMPERIAL:  A randomized trial comparing the ELUVIATM stent versus ZILVER® PTX® stent for treatment of superficial femoral and/or proximal popliteal arteries.

For more in-depth information, please call 214.360.0869.

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