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Current Studies

 

Study Type: PULMONARY HYPRTENSION – BEAT
Overview: This study will compare the effect of BPS-314d-MR (Beraprost – an orally bioavailable prostacyclin analogue) versus placebo added to treprostinil, inhaled (Tyvaso) on the composite endpoint of time-to-clinical worsening, defined as the time from randomization to clinical event (death, hospitalization due to worsening PAH, initiation of parenteral prostacyclin, disease progression, or unsatisfactory long-term clinical response).
Goal of the study:  Candidates who consent to the study and are eligible, but not currently taking inhaled treprostinil (Tyvaso) will enter a run-in period on inhaled treprostinil to achieve 90 days of experience to ensure drug tolerability before being randomized. After 90 days of inhaled treprostinil, patient will be randomized 1:1 to active or placebo study drug. Patients will return to the study site for visits at baseline, week 4, week 8, week 12, and then for quarterly visits thereafter.

 

Study Type: CAD & DIABETES – HARMONY
Overview: This study is a long term randomised, double-blind, placebo-controlled study to determine the effect of albiglutide, when added to standard blood glucose lowering therapies, on major cardiovascular events in patients with Type 2 diabetes mellitus.
Goal of the study: Candidates will receive standard of care which can be adjusted by their PCP during the study according to clinical need. The study comparison is between albiglutide added to standard of care and standard of care alone. Men or women with a diagnosis of type 2 diabetes that are at least 40 years of age with CAD, Cerebrovascular disease or Peripheral vascular disease with a  HbA1c of greater than 7%.  They cannot be on a GLP-1 receptor agonist or have an eGFR of < 30. The patient will  be randomized 1:1 active to placebo study drug and will be followed every 4 months in the clinic until the trial is completed.

 

Study Type: HEART FAILURE – CARDIOMEMS POST APPROVAL STUDY
Overview: The CardioMEMS HF System consists of a wireless, battery-less pressure sensor implanted into the pulmonary artery and external electronics that powers and communicates with the sensor and transmits pulmonary artery pressure waveforms and measurements to a secure website for Investigator review and patient management.
Goal of the study:  The purpose of this Post Approval Study is to evaluate the use of the CardioMEMS HF System in patients with Class III Heart Failure in a commercial setting.

 

Study Type: Atrial Fibrillation – GENETIC AF:
Overview: This study will compare the effects of bucindodol hydrochloride to metoprolol succinate (Toprol-XL) on the recurrence of symptomatic AF in people who have heart failure and a specific genotype (b1 389Arg/Arg AR variant).   Bucindolol has been shown in a previous study with heart failure that patients that have the specific genotype (b1 389Arg/Arg AR) who received bucindolol were less likely to develop AF than patients given a placebo.
Goal of the study: Candidates need a reduced left ventricular ejection fraction and at least one episode of symptomatic paroxysmal or persistent atrial fibrillation within 120 days of screening, have the specific genotype (b1 389Arg/Arg AR) and clinically appropriate cardioversion if atrial fibrillation/atrial Flutter is present 3 weeks after study drug initiation.

 

 Study Type: Pulmonary Artery Hypertension – REATA:
 Overview: A Dose Ranging Study of the Efficacy and safety of Bardoxolone Methyl in Patients with Pulmonary Arterial Hypertension.  This is a two part trial that will study safety, tolerability and efficacy of bardoxolone methyl in patients with WHO Group 1 Pulmonary Arterial Hypertension. Part 1 will be a double-blind, randomized, dose-ranging, placebo-controlled treatment period and Part 2 will be an extension period.
 Goal of the study:  Eligible patients must have been receiving an oral, disease-specific PAH therapy consisting of an endothelin-receptor antagonist ERA and/or a phosphodiesterase type-5 inhibitor (PDE5i).  Doses of prior therapy must have been stable for at least 90 days prior to Day 1.  Subjects need to be between 18 and 75, with diagnosis of PAH WHO Group I, NYHA FC II or III.  Need to have a Right Heart Cath within 36 months and a BNP of less than 200.

 

 Study Type: ANTI-PLATELET – EVOLVE (SHORT DAPT)
 Overview: This study is designed to assess the safety of 3 month dual antiplatelet therapy in patients at high risk for bleeding undergoing percutaneous coronary intervention with the SYNERY Everolimus-Eluting Platinum Chromium Coronary Stent System.
 Goal of the study:  To assess the safety of 3 months DAPT in subjects at high risk for bleeding undergoing PCI with the SYNERGY Stent System.

 

 Study Type: PAROXYSMAL SUPRA-VENTRICULAR TACHYCARDIA MILESTONE
 Overview:  This is an electrophysiological study of intranasal administration of a drug MSP-2017 for the conversion of induced paroxysmal supraventricular tachycardia to sinus rhythm.
 Goal of the study:  Is to demonstrate the superiority of at least 1 dose of intranasal MSP-2017 over placebo in terminating paroxysmal supraventricular tachycardia induced in an electrophysiology laboratory.

 

 Study Type: INTERNATIONAL STUDY OF COMPARATVE HEALTH EFFECTIVENESS WITH MEDICAL & INVASIVE APPROACHES ISCHEMIA
 Overview:  This study compares an initial strategy of cardiac catheterization and optimal revascularization and optimal medical therapy with a conservative strategy of optimal medical therapy alone in patients with at least moderate ischemia on stress imaging.
 Goal of the study:  Is to determine whether and invasive strategy of routine early cardiac catheterization with intent for optimal revascularization in addition to optimal medical therapy in patients with stable ischemic heart disease and at least moderate ischemia on stress imaging reduces the incidence of the composite of cardiovascular death or nonfatal myocardial infarction compared with a conservative strategy of optimal medical therapy alone.
Study Type: PACEMAKER  – LEADLESS II Study
Overview: The sponsor developed a leadless pacemaker system (Nanostim LP) to eliminate leads, pockets and connectors required by conventional pacemakers and to eliminate associated complications.
Goal of the study:  The intent of this study is to evaluate the safety and effectiveness of the implanted NANOSTIM LP for treatment of bradycardia.  A Nanostim Programmer Link is also investigational, will be used in conjunction with the NANSTIM LP.

 

Study Type: CSL112_2001
A Phase 2, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Safety and Tolerability of Multiple Dose Administration of CSL112 in Subject with Moderate Renal Impairment and Acute Myocardial Infarction.
Overview: CSL112 drug product resembles nascent high density lipoprotein (HDL).  It is a novel formulation of apolipoprotein A-I (apoA-I), phosphatidylcholine (PC) and cholate; and is stabilized by sucrose. It is being developed for the reduction of recurrent cardiovascular events after AMI.  Patients who experience an AMI event are at high risk for a recurrent CV event and mortality is inversely related to renal function status.  The identification of therapies that are safe and effective in RI patients would represent an important advancement in medical therapy.  Primary endpoint is to assess the renal safety of CSL112 in subjects with moderate RI and AMI after administration of up to 4 weekly infusions of CSL112.  Subjects will receive 4 weekly 2 hour IV infusions of 6 g CSL112 or placebo, 2:1 ratio.  Subjects will have 8 study visits and be followed for 60 days.

Major Inclusions: 

  • Evidence of myocardial necrosis in a clinical setting consistent with a type I AMI
  • Evidence of moderate RI (eGFR > 30 and < 60).

Major Exclusions:

  • Planned CABG during Active Treatment Period.
  • Ongoing hemodynamic instability.
  • LVEF < 30%

Questions: Call Mary Soltau 303-703-2191 or Rebecca Wimmer 303-715-2275

 

Goal of the study:

 

If you are interested in participating in or learning more about our research program, please ask your cardiologist or call 303-744-1065 and ask for the research department.