Heart Failure Studies

SHIELD II

Principle Investigator: Murtuza J. Ali, MD

 Supporting Patients Undergoing HIgh-Risk PCI Using a High-Flow PErcutaneous Left Ventricular Support Device (Heartmate PHP)

Main Inclusion:

  • Undergoing elective or urgent high risk PCI procedure and is hemodynamically stable
  • Indicated for a revascularization of at least one de novo or restenotic lesion in a native coronary vessel or bypass graft
  • Complex CAD makes hemodynamic instability resulting from repeat episodes of reversible myocardial ischemia during PCI likely. Complex CAD is defined as an ejection fraction of ≤35% AND at least one of the following:
    • intervention of the last patent coronary conduit, OR
    • intervention of an unprotected left main artery, OR
    • intervention on patient presenting with triple vessel disease defined as at least one significant stenosis (at least 50% diameter stenosis on visual assessment) in all three major epicardial territories

 

DCM Precision Medicine Study

Principle Investigator: Frank Smart, MD

Main Inclusion:

  1. DCM (LVEF <50% and LV enlargement)
  2. Detectable causes of cardiomyopathy, except genetic, excluded beyond reasonable doubt (idiopathic)
  3. Non-Hispanic Ethnic Origin

Main Exclusion:

  1. CAD causing ischemic cardiomyopathy
  2. Primary valvular disease
  3. Other forms of cardiomyopathy such as Hypertrophic, Restrictive, etc.

 

GALACTIC-HF

Principle Investigator: Frank Smart, MD

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

Major Inclusion:

  1. History of chronic HF (requiring treatment >30 days)
  2. LVEF ≤ 35% currently, measured within 12 months of screening
  3. NYHA II-IV
  4. Currently hospitalized for Primary reason of HF, or one of the following:
    • HF hospitalization within one year
    • Urgent visit to ED with primary reason of HF
  5. BNP ≥ 125 pg/mL, or BNP ≥ 375 pg/mL with A-fib/flutter

Major Exclusion:

  1. Acute coronary syndrome, stroke, TIA, or major cardiac surgery or intervention within 3 months prior to randomization
  2. ICD, pacemaker, or monitoring device implant within 30 days of randomization
  3. Severe uncorrected valvular heart disease, hypertrophic or infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, or clinically significant congenital heart disease
  4. Untreated severe ventricular arrhythmia
  5. Chronic antiarrhythmic therapy, except amiodarone

 

EMPEROR-HFpEF

Principle Investigator: Frank Smart, MD

A phase III randomised, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure with preserved Ejection Fraction

Major Inclusion:

  1. History of chronic HF diagnosed for at least 3 months and currently NYHA II-IV
  2. LVEF ≥ 40% currently, measured within 12 months of screening with no prior measurement of LVEF<40% under stable conditions
  3. Evidence of structural heart disease (LA enlargement or LV hypertrophy) -OR- Documented HF hospitalization within 12 months
  4. Oral diuretics stable for 1 week prior to randomization
  5. eGFR ≥ mL/min/1.73m2

Major Exclusion:

  1. Acute coronary syndrome, stroke, TIA, or major cardiac surgery or intervention within 3 months prior to screening
  2. Heart transplant recipient or listed for transplant
  3. ICD within 3 months
  4. CRT
  5. Severe uncorrected valvular heart disease, hypertrophic or infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, or clinically significant congenital heart disease
  6. Untreated severe ventricular arrhythmia

 

TRANSFORM-HF

Principle Investigator: Frank Smart, MD

Torsemide comparison with Furosemide FOR Management of Heart Failure (TRANSFORM-HF)

Major Inclusion:

  1. Patient hospitalized for Heart Failure
  2. Outpatient plans for oral loop diuretic regiment

Major Exclusion:

  1. End-stage renal disease requiring renal replacement therapy
  2. History of heart transplant or listed for transplant
  3. Implanted LVAD or implant anticipated <3 months
  4. Known hypersensitivity to furosemide, torsemide, or related agents

 

PARTNER 3-UPR

Principle Investigator: Pedro Cox-Alomar, MD

A Prospective, Randomized, Controlled, Multi-Center Study to Establish the Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients who have Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement

Major Inclusion:

  1. Severe, calcific aortic stenosis defined as:
    • AVA ≤ 1.0 cm2 or AVA index ≤ 0.6 cm2/m2
    • Jet velocity ≥ 4.0 m/s or mean gradient ≥ 40 mmHg AND
    • 1) NYHA Functional Class ≥ 2 OR 2) exercise test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia OR 3) asymptomatic with LVEF <50%
  2. Patient has low risk of operative mortality and STS < 4

Major Exclusion:

  1. Evidence of acute MI within 30 days of implant
  2. Unicuspid, bicuspid, or non-calcified aortic valve
  3. Severe aortic or mitral regurgitation (>3+)
  4. Complex CAD
  5. LVEF < 30%
  6. HOCM
  7. eGFR < 30ml/min
  8. Stroke or TIA within 3 months of implant

 

GUIDE-HF

Principle Investigator: Murtuza J. Ali, MD

Hemodynamic-GUIDEd Management of Heart Failure (CardioMEMS indication expansion trial)

Major Inclusion:

  1. HF diagnosis and treatment for HF > 90 days prior to screening
  2. On stable medical therapy for >30 days
  3. HF hospitalization within 12 months of consent with elevated BNP (corrected to BMI) within 30 days defined as:      
    1. Subjects with LVEF ≤ 40%: NT-proBNP ≥ 1000 pg/mL (or BNP ≥ 250 pg/mL).
    2. Subjects with LVEF > 40%: NT-proBNP ≥ 700 pg/mL (or BNP ≥ 175 pg/mL).

Major Exclusion:

  1. Intolerance to all ACE-I, ARB, ARNi, and beta-blockers
  2. ACC/AHA Stage D refractory HF
  3. Received or likely to receive advanced therapy in next 12 months (transplant, mechanical circulatory support, etc.)
  4. eGFR < 25 ml/min and non-responsive to diuretic therapy, or receiving chronic dialysis
  5. Intolerance of dual antiplatelet or anticoagulation therapy for 1 month post-implantation
  6. Implanted mechanical right heart valve(s) -OR- Unrepaired severe valvular disease
  7. Implanted with CRT, CRT-P, or CRT-D < 90 days

 

 

 

EP Studies

N/A