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Ischemia

Enrollment began September, 2013 and continues

Study aims to determine whether an invasive strategy (routine early cardiac catheterization with intent for optimal revascularization) in addition to optimal medical therapy reduces the incidence of the composite of cardiovascular death or nonfatal myocardial infarction compared with a conservative strategy of optimal medical therapy alone (cardiac catheterization and revascularization reserved for patients with refractory angina, ACS, acute ischemic HF or resuscitated cardiac arrest).

Who Qualifies?
  • Patients with stable ischemic heart disease and at least moderate ischemia on stress imaging can qualify (nuclear stress test or stress echo). 
Excluded:
  • History of CABG
  • PCI within the previous 12 months
  • LVEF < 35%
  • History of unprotected left main stenosis >50% on prior coronary computed tomography angiography (CCTA) or prior cardiac catheterization (if available).
  • Prior known coronary anatomy unsuitable for either PCI or CABG
  • Unacceptable level of angina despite maximal medical therapy
  • Acute coronary syndrome within the previous 2 months

RAID

Enrollment expected to begin in April, 2014
The study aims to determine whether ranolazine administration will decrease the likelihood of a composite arrhythmia endpoint consisting of ventricular tachycardia or ventricular fibrillation (VT/VF) requiring ATP therapy, ICD shocks, or death. Patients will receive either ranolazine or placebo during the trial.

Who Qualifies?

The study population will consist of patients with ischemic or non-ischemic cardiomyopathy with existing devices (ICD/CRT-D) and meet the criteria listed below:

  • Qualified for or with existing ICD (or CRT-D) after documented VT/VF or cardiac arrest.
  • Patients with existing devices (ICD/CRT-D), who have experienced at least ONE episode of VT/VF appropriately treated with ICD therapy (ATP or shock).
  • Patients who have been implanted within the last 2 years (initial ICD/CRT-D implants, including upgrades from pacemakers) who have NOT experienced VT/VF treated with ICD therapy (ATP or shock), AND who have ONE of the following additional criteria BUN≥26 mg/dl or QRS>120ms or Atrial Fibrillation

RELAX-2

Enrollment expected to begin April, 2014

The purpose of this study is to evaluate the efficacy, safety, and tolerability of IV serelaxin when added to standard therapy in acute heart failure (AHF) patients. The primary objective is to demonstrate that serelaxin is superior to placebo in reducing CV death in acute heart failure patients during a follow-up period of 180 days.

The study population will consist of patients admitted to the hospital for AHF with mild to moderate renal impairment. Patients will be randomized within 16 hours from presentation to hospital/ER.

Ranolazine Mediated PVC Reduction in Ischemic Heart Disease
Enrollment expected to begin in April, 2014

This is an Investigator Sponsored Research (ISR) program funded by Gilead Sciences. The purpose of this study is to determine if Ranolazine, through a reduction in PVC burden, can manifest beneficial effects on coronary ischemia.

Who Qualifies?
  • History of ischemic heart disease (prior bypass or coronary stenting, documentation on cardiac catheterization, nuclear SPECT imaging, cardiac MR, stress echocardiography, or exercise stress testing)
  • Elevated PVC burden (1%) on prior Holter/event monitor in previous 12 months or evidence for PVC(s) on baseline ECG within prior 12 months.