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Current Studies

 

Study Type: STATIN INTOLERANT – CLEAR
Overview: This study will evaluate whether administration of bempedoic acid 180 mg/day versus placebo reduces the risk of major adverse cardiovascular events (MACE) in patients with, or at high risk for, cardiovascular disease who are statin intolerant. About 12,604 patients will be randomized 1:1 to receive either bempedoic acid or placebo.
Goal of the study:  Candidates need to be intolerant to 1 or more different statins, intolerant due to an adverse safety effect that started or increased during statin therapy and resolved or improved when statin therapy was discontinued.

 

Study Type: HEART FAILURE – EMPEROR 1245
Overview: Two studies to evaluate the efficacy and safety of once-daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure with preserved Ejection Fraction (HFpEF). 
Goal of the study: The goal of this event-driven trial is to demonstrate the superiority of empagliflozin 10 mg compared to placebo in patients with symptomatic, chronic heart failure with preserved ejection fraction (LVEF > 40%) under stable treatment of heart failure symptoms.

 

Study Type: HEART FAILURE – GALACTIC
Overview: A Study to Assess the Efficacy and Safety of Omecamtiv Mecarbil on Mortality and Morbidity in Subjects with Chronic Heart Failure with Reduced Ejection Fraction
Goal of the study: To evaluate the effects of treatment with Omecamtiv Mecarbil (OM) compared with placebo on the time to cardiovascular (CV) death, or first heart failure event in subjects with chronic heart failure with reduced ejection fraction receiving standard of care therapy.

 

Study Type: Heart FID
Overview: This study is to determine the efficacy and safety of iron therapy using IV ferric carboxymaltose (FCM) compared to placebo, in the treatment of participants in heart failure with a reduced ejection fraction and with iron deficiency.
Goal of the study: The goal of the study is to asses the effects of IV ferric carboxymaltose compared to placebo on the 12-month rate of death, hospitalization for worsening heart failure and the 6-month change in the 6-minute walk test for patients in heart failure with iron deficiency.

 

Study Type: PERFECT
Overview: A study to evaluate the safety and efficacy of inhaled Treprostinil in patients with Pulmonary Hypertension due to Chronic Obstructive Pulmonary Disease (PH-COPD).
Goal of the Study: To demonstrate the efficacy of inhaled Treprostinil compared to placebo in improving exercise ability as measured by change from Baseline 6MWD following 12 weeks of active treatment in subjects with PH-COPD.

 

 Study Type: CAPACITY
 Overview: This study is to Evaluate the Safety and Efficacy of Different Doses of IW-1973 over 12 Weeks in Patients with Heart Failure with Preserved Ejection Fraction (CAPACITY HFpEF)
 Goal of the study:  The first goal of the study is to assess the safety of oral IV-1973 when administered for approximately 12 weeks to patients with heart failure with preserved ejection fraction.  The second is to evaluate the effect of oral IW-1973 on peak exercise capacity when administered for approximately 12 weeks to patients with HFpEF.

 

Study Type: SERENADE
Overview: This study is to evaluate the efficacy and safety of macitentan in subjects with heart failure with preserved ejection fraction and pulmonary vascular disease.
Goal of the study:  A study to evaluate whether macitentan 10 mg reduces n-terminal pro-brain natriuretic peptide (NT-pro-BNP) versus placebo at week 24 in subjects with heart failure with preserved ejection fraction HFpEF) and pulmonary vascular disease.  Also, to evaluate the effect of macitentan 10 mg as compared to placebo on daily physical activity, quality of life and worsening heart failure.

 

Study Type: SOUTHPAW
Overview: Two studies evaluating the Safety and Efficacy of Oral Treprostinil in Subjects with Pulmonary Hypertension (PH) in Heart Failure with Preserved Ejection Fraction (HfpEF). The second study is an open-label extension study for enrolled subjects with long-term follow up.
Goal of the study:  The goal of this study is to assess the effect of oral treprostinil compared with placebo on change in exercise capacity as measured by change in 6 MWD from Baseline to Week 24 in subjects with PH associated with HFpEF.

 

Study Type: Persistent Atrial Fibrillation Ablation – PERSIST-END
Overview: This study looks at the safety and effectiveness of the TactCath ablation catheter for use in cardiac electrophysiological mapping and for the treatment of recurrent symptomatic persistent atrial fibrillation (AF) that is non-responsive to medication treatment.
Goal of the study: To evaluate the safety and effectiveness of the TactiCath ablation catheter.

 

Study Type: Diastolic Heart Failure – REDUCE LAP
Overview: A study to evaluate to evaluate the Corvia  Medical, Inc. InterAtrial Shunt Device (IASD) System designed to reduce left atrial pressure, with a standard catheter-based approach.
Goal of the study: The primary objective of this randomized controlled clinical trial is to evaluate the clinical efficacy and safety of the IASD device in asymptomatic heart failure patients with and left ventricular ejection fraction of > 40% and elevated left-sided filling pressures despite standard guideline-directed medical therapy.

 

Study Type: Paroxysmal Supraventricular Tachycardia – NODE 301  
Overview: A study to evaluated the safety of Entripamil Nasal Spray for the termination of spontaneous episodes of paroxysmal supraventricular tachycardia.
Goal of the study: The primary objective of this study is to determine whether entripamil nasal spray 70mg self-administered by patients is superior to placebo at terminating episodes of paroxysmal supraventricular tachycardia in an outpatient setting.

 

Study Type: Acute Coronary Syndrome – AEGIS II
Overview: A double-blind, randomized, placebo-controlled study to investigate the efficacy of safety of CSL112 in subjects with an acute coronary syndrome.
Goal of the study: The primary objective of this study is to evaluate the efficacy of CSL112 on reducing the risk of cardiovascular death, myocardial infarction or stroke from the time of randomization through 90 days in subjects with an acute coronary syndrome.  Subjects receive 4 weekly 2 hour infusions of CSL112 or placebo.

 

Study Type: PFO and Stroke – AMPLATZER PFO Occluder Post Approval Study
Overview: The AMPLATZER PFO Occluder device is implanted in all subjects who enrolled in the study.
Goal of the study: This clinical study is intended to demonstrate the safety and effectiveness of the AMPLATZER PFO Occluder, in a post-approval setting, in patients with a PFO who have had a cryptogenic stroke confirmed by a study neurologist.

 

Study Type: GuideHF-CardioMEMS
Overview: This study is intended to demonstrate the effectiveness of the CardioMEMS HF Systems device in patients with a New York Heart Association (NYHA) Class II, III or IV Heart Failure with either an elevated NT-proBNP (or BNP) and/or a prior Heart Failure hospitalization within the last 12 months.  All subjects will receive a CardioMEMS HF Systems device and will either be randomized in a 1:1 ratio into either a treatment group or a control group.
Goal of the study: CardioMEMS is currently approved NYHA Class III patients.  The GuideHF study will demonstrate the recommended indication for patients with other NYHA Class designations to have a benefit from the device.  Benefits including but not limited to reduction in Heart Failure hospitalizations, cost savings, and improved preventative care.

 

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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.