Clinical Research
What is Clinical Research?
Preventive cardiology and clinical research make available the latest techniques developed for the treatment of heart disease. Many exciting tools have been made available through our research and clinical care programs that help patients prevent, and in some cases, reverse heart disease. Some of our programs have offered an alternative to angioplasty and bypass surgery through aggressive cholesterol reduction and lifestyle changes. Research projects include pharmaceutical trials, clinical outcome studies, and cardiac device trials. Our unique offering of multi-site group research covers a base much broader than is possible to obtain within a single hospital setting.
Benefits to patients include the availability of screening for protocol criteria and regular visits to the cardiologist during the protocol period.
Open & Enrolling Foothill Cardiology/Huntington Hospital Clinical Research Studies:
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STUDY TITLE
DETAILS
BEAT HF
CardioMEMS PAS
CIRT
ENABLE MRI
GENETIC-AF
JAVA-CRT
LEADLESS II
MADIT-SICD
PARADISE-MI
PERSPECTIVE
PIONEER-HF
PORTICO
smartADHERE
BEAT HF
PI: Rashtian
Barostim neo® - Baroreflex Activation Therapy® for Heart Failure (BeAT-HF)
Currently NYHA Class II or III heart failure.
Left ventricular ejection fraction ≤ 35%.
On optimal, stable, Guideline Directed Medical Therapy (GDMT) specific guidelines for the treatment of heart-failure.
Subjects who have received CRT within six months of randomization or is actively receiving CRT.
Subjects who have currently have a Class I indication for a CRT device for the treatment of congestive heart failure.
AHA/ACC Stage D heart failure within 45 days.
PRIMARY INCLUSION CRITERIA
PRIMARY EXCLUSION CRITERIA
CardioMEMS Post Approval Study
CardioMEMS PAS
PI: Rao
Subjects with history of recurrent
(> 1) pulmonary embolism or deep vein thrombosis.
Subjects who are unable to tolerate a right heart catheterization.
Subjects who have had a major cardiovascular event within 2 months.
Subjects with CRT implanted within 3 months
PRIMARY EXCLUSION CRITERIA
Diagnosis of NYHA Class III Heart Failure.
At least 1 HF hospitalization within preceding 12 months.
Subjects with reduced LVEF heart failure should be receiving a beta blocker for 3 months and an ACE-I or ARB for one month unless in the subject is intolerant to beta blockers, ACE-I or ARB.
Subjects with a BMI ≤ 35.
PRIMARY INCLUSION CRITERIA
CIRT
PI: Conrad
Cardiovascular Inflammation Reduction Trial
Documented past history of myocardial infarction OR past evidence of multivessel coronary artery disease by angiography.
History of type 2 diabetes or metabolic syndrome at time of study enrollment.
Requirement for use of drugs that alter folate metabolism (trimethoprim/sulfamethoxazol) or reduce tubular excretion (probenecid) or known allergies to antibiotics making avoidance of trimethoprim impossible.
Current indication for methotrexate therapy.
Chronic use of oral steroid therapy or other immunosuppressive or biologic response modifiers.
NYHA Class IV congestive heart failure.
PRIMARY INCLUSION CRITERIA
PRIMARY INCLUSION CRITERIA
ENABLE MRI
PI: Rashtian
Expanding MRI Access for Patients with New and Existing ICDs and CRT-Ds
Subject implanted with an ICD or CRT-D pulse generator with battery at explant status.
Subject with active or abandoned cardiac rhythm devices, components or accessories.
Presence of metallic objects that represent a contraindication to MR imaging.
Subject is not clinically capable of tolerating the absence of pacing or Resynchronization therapy during MRI.
Subject is not clinically capable of tolerating the absence of Tachycardia therapy support during MRI.
PRIMARY EXCLUSION CRITERIA
Subject is implanted with a functional and stable CRT-D or ICD system consisting of Boston Scientific MR Conditional components as specified in protocol.
PRIMARY INCLUSION CRITERIA
GENETIC-AF
PI: Rashtian
A Genotype-Directed Comparative Effectiveness Trial of Bucindolol and Toprol-XL for the Prevention of Symptomatic Atrial Fibrillation/Atrial Flutter in Patients with Heart Failure
Study participants must possess the β1389Arg/Arg genotype (About 50% of people with heart failure have this specific gene variant – blood test will be performed by study).
Pre-existing cardiac device that measures AF burden or agree to have a Reveal LINQ device inserted as clinically indicated to assess AF burden.
History of HFREF.
At least one symptomatic paroxysmal or persistent AF episode within 180 days.
Clinically appropriate for ECV if AF/AFL is present.
Receiving guideline indicated oral anticoagulation therapy.
NYHA Class IV symptoms.
Significant fluid overload.
More than two ECV procedures within prior 6 months.
The presence of a LVAD or a condition that is likely to require LVAD within 6 months.
History of a successful AV node ablation.
History of AF/AFL ablation within prior 30 days
History of untreated second degree Mobitz II or third degree heart block.
History of untreated symptomatic bradycardia.
PRIMARY INCLUSION CRITERIA
PRIMARY EXCLUSION CRITERIA
JAVA-CRT
PI: Rashtian
Junctional AV Ablation in CRT-D Patients with Atrial Fibrillation
Ventricular rate > 90 bpm at rest within 1 year
Ventricular rate < 50 bpm at rest within 1 year
Heart block/symptomatic bradycardia that necessitates permanent pacing
ACS/CABG/PCI within 3 months
Enzyme-positive MI within 3 months
Severe aortic or mitral valvular heart disease eligible for repair/replacement procedures
Coronary disease requiring revascularization and likelihood of CABG or PCI within 3 months
Prior AF ablation procedure any time in the past
PRIMARY EXCLUSION CRITERIA
On optimal pharmacologic therapy
Existing indication for CRT device with initial implant scheduled within 1 calendar month
Ischemic or nonischemic cardiomyopathy
LVEF ≤ 35% within previous 12 calendar months
NYHA class II-IV (ambulatory)
QRS ≥ 120 ms for LBBB and ≥ 150 ms for non-LBBB patients within prior calendar year
Continuous AF > 6 calendar months
PRIMARY INCLUSION CRITERIA
LEADLESS II
PI: Rashtian
A Safety and Effectiveness Trial for a Leadless Pacemaker System
Clinical indication for single chamber pacemaker including
Life expectancy of at least one year.
Known pacemaker syndrome.
Pre-existing endocardial pacing or defibrillation leads.
Current implant of conventional or subcutaneous ICD or CRT.
Cardiovascular or peripheral vascular surgery within 30 days.
PRIMARY INCLUSION CRITERIA
PRIMARY EXCLUSION CRITERIA
MADIT-SICD
PI: Rashtian
Multicenter Automatic Defibrillator Implantation Trial with Subcutaneous Implantable Cardioverter Defibrillator
Ejection fraction >50% or <36% within 12 months and at least 3 calendar months after MI, PCI or CABG.
Existing guideline based indication for an ICD, pacemaker, CRT, or CRT-D therapy.
Existing or previously implanted ICD, CRT, CRT-D, or pacemaker device system.
PRIMARY EXCLUSION CRITERIA
Age ≥ 65 years on date of consent.
DM treated with oral hypoglycemic agents, non-insulin injectable and/or insulin ≥ 3 months.
LVEF of 36-50% within 12 calendar months and at least 3 months after most recent MI, PCI or CABG.
PRIMARY INCLUSION CRITERIA
PARADISE-MI
PI: Conrad
Prospective ARNI versus ACE inhibitor trial to
DetermIne Superiority in reducing heart failure Events after Myocardial Infarction
Known history of chronic HF prior to randomization.
Cardiogenic shock within 24 hours.
Persistent clinical HF.
CABG performed or planned for index MI.
Clinically significant right ventricular MI as index MI.
Symptomatic hypotension.
Known history of angioedema.
Stroke or TIA within 1 month
Known or suspected bilateral renal artery stenosis
Clinically significant obstructive cardiomyopathy
Open-heart surgery performed within 1 month or planned cardiac surgery within 3 months.
PRIMARY EXCLUSION CRITERIA
Diagnosis of spontaneous AMI
Evidence of LV systolic dysfunction and/or pulmonary congestion requiring intravenous
treatment associated with the index MI event.
LVEF ≤40% after index MI presentation
At least one of the following 8 risk factors:
• Age ≥ 70 years
• eGFR <60 mL/min/1.73 m2
• Type I or II diabetes mellitus
• Documented history of prior MI
• Atrial fibrillation associated with index MI
• LVEF <30% associated with index MI
• Worst Killip class III or IV associated with index MI requiring intravenous treatment
• STEMI without reperfusion therapy within the first 24 hours after presentation
Hemodynamically stable.
PRIMARY INCLUSION CRITERIA
PERSPECTIVE
PI: Conrad
A multicenter, randomized, double-blind, active-controlled study to evaluate the effects of sacubitril/valsartan compared to valsartan on cognitive function in patients with chronic heart failure and preserved ejection fraction
≥60 years of age.
Chronic heart failure with current symptom(s) (NYHA class II-IV).
LVEF >40% by echo.
Patient with evidence of adequate functioning (e.g., intellectual, motor, visual and auditory.
Current acute decompensated HF requiring augmented therapy with diuretics,
Vasodilators and/or inotropic drugs.
Acute coronary syndrome or elective PCI within 30 days.
History of hereditary or idiopathic angioedema or angioedema related to previous ACEi or ARB therapies.
Life-threatening or uncontrolled dysrhythmia, including symptomatic or sustained ventricular tachycardia and atrial fibrillation.
PRIMARY INCLUSION CRITERIA
PRIMARY EXCLUSION CRITERIA
PIONEER-HF
PI: Conrad
A multicenter, randomized, double-blind, double dummy, parallel group, active-controlled 8-week study to evaluate the effect of sacubitril/valsartan versus enalapril on changes in NT-proBNP and safety and tolerability of in hospital initiation of sacubitril/valsartan compared to enalapril in HFrEF patients who have been stabilized following hospitalization for acute decompensated heart failure(ADHF).
Currently hospitalized for ADHF.
LVEF ≤40% within the past 6 months using Echocardiography, MUGA scan, CT scanning, MRI or ventricular angiography.
Elevated NT-proBNP ≥ 1600pg/mL OR BNP ≥400 pg/mL during current hospitalization.
Currently taking sacubitril/valsartan tablets or any use within the past 30 days.
History of hypersensitivity, contraindications, or intolerance to ACEIs, ARBs, or Sacubitril.
Known history of angioedema related to previous ACE inhibitor or ARB therapy.
Requires treatment with both ACEI and ARB.
ACS, stroke, TIA; cardiac, carotid or major CV surgery; PCI or carotid angioplasty, within 1 month.
Dyspnea due to non-cardiac, non-heart failure causes.
Intended coronary or carotid artery revascularization within the 6 months.
Implant of CRTD within 3 months or intent to implant a CRTD.
PRIMARY INCLUSION CRITERIA
PRIMARY EXCLUSION CRITERIA
PORTICO
PI: Durairaj
Portico™ Re-Sheathable Transcatheter Aortic Valve System
Evidence of an acute myocardial infarction within 30 days prior to index procedure.
Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified as verified by echocardiography.
Mixed aortic valve disease.
Any percutaneous coronary or peripheral interventional procedure performed within preceding 30 days.
Pre-existing prosthetic heart valve or other implant in any valve position.
PRIMARY EXCLUSION CRITERIA
Subjects must have co-morbidities such that the surgeon and cardiologist concur that the predicted risk of operative mortality is ≥15% or a minimum STS score of 8%.
Subject has senile degenerative aortic valve stenosis with echocardiographically derived criteria:
- mean gradient >40 mmHg or
- jet velocity greater than 4.0 m/s or
- Doppler Velocity Index <0.25
- and an initial aortic valve area (AVA) of ≤ 1.0 cm2.
Subject has symptomatic aortic stenosis as demonstrated by NYHA Functional Classification of II, III, or IV.
Subject’s aortic annulus is 19-27mm diameter as measured by CT or TEE.
PRIMARY INCLUSION CRITERIA
smartADHERE
PI: Rashtian
Smartphones to Improve Rivaroxaban ADHEREnce in Atrial Fibrillation
Anticipated rivaroxaban use <12 months.
Prescribed rivaroxaban for indications other than atrial fibrillation.
Current use of:
- specialized anticoagulation clinics for rivaroxaban medication management;
- specialized pharmacist-led adherence or refill monitoring; or
- enrollment in a medication adherence program
Current use of other adherence tracking devices.
PRIMARY EXCLUSION CRITERIA
History of atrial fibrillation.
Taking newly-prescribed rivaroxaban for atrial fibrillation for ≤90 days or who are about to initiate therapy
Possession of a compatible smartphone with an active phone number, text and data plan.
PRIMARY INCLUSION CRITERIA