Clinical Trials

Emory Cardiovascular Biobank

Sponsor: Emory University

Purpose: Emory Cardiovascualr Biobank is a prospective study of patients who undergo cardiac catheterization for suspected coronary artery disease which investigates the role of novel biomarkers in relation to cardiovascular risk. More information about this study

Inclusion Criteria:

Patients with active cardiovascular disease including but not limited to

• Ischemic Heart Disease
• Heart Failure and Cardiomyopathies
• Peripheral Vascular Disease
• Valve disease
• Adult Congenital Heart disease
• Electrophysiological Disorders

Principal Investigator: Arshed Quyyumi

Research Coordinator: Zain Alvi

Status: Recruiting

Study to Investigate CSL112 in Subjects with Acute Coronary Syndrome (AEGIS-II)

Purpose: This is a phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of CSL112 on reducing the risk of major adverse CV events in subjects with acute coronary syndrome (ACS) diagnosed with either ST-segment elevation myocardia infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI), including those managed with percutaneous coronary intervention (PCI) or medically managed.

Inclusion Criteria:

• Male or female least 18 years of age
• Evidence of myocardial necrosis, consistent with type I (spontaneous) MI
• No suspicion of acute kidney injury 
• Evidence of multivessel coronary artery disease and at least 1 of the following established risk factors: age > 65 years, prior history of MI, diabetes mellitus, or peripheral artery disease.

Principal Investigator: Arshed Quyyumi, MD
Research Coordinator: Kiran Ejaz

This study is no longer enrolling.

BMAD Treatment: Benefits of Microcor (μCor) in Ambulatory Decompensated Heart Failure

Sponsor: Zoll

Purpose: To assess investigator engagement of μCor system data in the context of heart failure management

Inclusion Criteria:

• 4.1.1 Subjects hospitalized for acute decompensated heart failure and enrolled in the study within 10 days post-hospital discharge.
• 4.1.2 Subjects who have had an acute heart failure event requiring medical management in the previous 180 days of index hospitalization admission. This acute heart failure event admission must be at least 2 weeks apart from the event admission in 4.1.1
• 4.1.3 Subjects 21 years of age or older on the day of screening.

Exclusion Criteria:

• 4.2.1 Subjects who are wearing the wearable cardioverter defibrillator (WCD)
• 4.2.2 Subjects not expected to survive one year from enrollment from non-cardiac disease.
• 4.2.3 Subjects with skin allergy or sensitivity to medical adhesives.
• 4.2.4 Subjects anticipated to start dialysis within 90 days.
• 4.2.5 Subjects currently implanted with an S-ICD system.
• 4.2.6 Subjects who received a percutaneous coronary intervention (PCI) less than 24 hours after onset of heart failure related symptoms during index hospitalization.
• 4.2.7 Subjects who are unable to participate in all follow up visits.
• 4.2.8 Subjects participating in research other than a registry at the time of enrollment.
• 4.2.9 Subjects currently implanted with an LVAD.
• 4.2.10 Subjects with self-reported pregnancy.
• 4.2.11 Subjects currently being actively managed with any device based remote HF monitoring.

Principal Investigator: Modele Ogunniyi MD, MPH 
Research Coordinator: Sabira Bacchus
Status: Recruiting

Evaluation of Major Cardiovascular Events in Patients With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated With Bempedoic Acid (ETC-1002) or Placebo (CLEAR Outcomes)

Sponsor: Esperion Therapeutics

Purpose: The purpose of this study is to determine if treatment with bempedoic acid (ETC-1002) versus placebo decreases the risk of cardiovascular events in patients who are statin intolerant.

Inclusion Criteria:

• Age between 18 and 85 years
• History of, or at high risk for, cardiovascular disease (CVD) including coronary artery disease, symptomatic peripheral arterial disease, cerebrovascular atherosclerotic disease, or at high risk for a cardiovascular event
• Patient reported history of statin intolerance (inability to tolerate 2 or more statins, one at a low dose)
• Men and nonpregnant, nonlactating women
• Fasting blood LDL-cholesterol between 100 and 190 mg/dL at screening

Exclusion Criteria:

• Fasting blood triglycerides greater than 500 mg/dL at screening
• Recent history of certain cardiovascular disease including transient ischemic attack (TIA), unstable or symptomatic cardiac arrhythmia, use of an implantable pacemaker or implantable cardioverter defibrillators, or coronary revascularization procedure
• History of heart failure
• Uncontrolled hypertension

Principal Investigator: Arshed Quyyumi, MD

This study is no longer enrolling.

COORDINATE-Diabetes: COOrdinating CaRDIology CliNics RAndomized Trial of Interventions to improve OutcomEs

Sponsor: Duke Clinical Research Institute (DCRI)

Purpose: To test the effectiveness of an innovative, clinic-level educational intervention to improve the management of patients with T2DM and CVD.

Inclusion Criteria:
Inclusion Criteria:

• Age ≥ 18 years old
• Diagnosis of Type 2 diabetes mellitus (T2DM)
• History of at least one of the following conditions:
  1. Coronary artery disease (defined as prior MI, coronary revascularization (CABG or PCI), and/or obstructive CAD (≥50%) as documented by angiography or CTA)
  2. Stroke and/or carotid artery stenosis (≥50%)
  3. Peripheral Arterial disease (defined as claudication with ABI<0.9, prior peripheral revascularization, and/or amputation due to circulatory insufficiency)
• Ability to communicate with site staff and understand and provide written informed consent and proof of Health Insurance Portability and Accountability Act (HIPAA) authorization

Exclusion Criteria:

• Determined to be highly unlikely to survive and/or to continue follow-up in that clinic for at least 1 year, as identified by site investigator
• GFR<30 mL/min/1.73m2
• Already on all guideline-recommended therapies for T2DM and CVD
• Absolute contraindication to any of the guideline recommended therapies for T2DM and CVD

Principal Investigator: Modele Ogunniyi MD, MPH 
Research Coordinator: Senait Asier
Status: Recruiting

DELIVER: Dapagliflozin Evaluation to Improve the LIVEs of Patients with PReserved Ejection Fraction Heart Failure.

Sponsor: Astra Zeneca

Purpose: To determine whether dapagliflozin is superior to placebo, when added to standard of care, in reducing the composite of CV death and HF events (hospitalization for HF or urgent HF visit) in patients with HF and preserved systolic function

Inclusion Criteria:
1.Provision of signed informed consent prior to any study specific procedures.
2.Male or female patients age ≥40 years.
3.Documented diagnosis of symptomatic heart failure (NYHA class II-IV) at enrolment, and a medical history of typical symptoms/signs of heart failure ≥6 weeks before enrolment with at least intermittent need for diuretic treatment.
4.Left Ventricular Ejection Fraction (LVEF) >40% and evidence of structural heart disease (i.e. left ventricular hypertrophy or left atrial enlargement ) documented by the most recent echocardiogram, and/or cardiac MR within the last 12 months prior to enrolment. For patients with prior acute cardiac events or procedures that may reduce LVEF, e.g. as defined in exclusion criterion 6, qualifying cardiac imaging assessment at least 12 weeks following the procedure/event is required.
5.Elevated NT-pro BNP levels.
6.Both ambulatory and hospitalised patients may be enrolled and randomised. Patients currently hospitalised for HF, must be off intravenous HF medications for at least 24 before randomisation.
Further details regarding inclusion criteria 4-6 may apply.

Exclusion Criteria:
1.Receiving therapy with an SGLT2 inhibitor within 4 weeks prior to randomisation or previous intolerance to an SGLT2 inhibitor.
2.Type 1 diabetes mellitus (T1D).
3.eGFR <25 mL/min/1.73 m2 (CKD-EPI formula) at Visit 1.
4.Systolic blood pressure (BP) <95 mmHg on 2 consecutive measurements at 5-minute intervals, at Visit 1 or at Visit 2.
5.Systolic BP≥160 mmHg if not on treatment with ≥3 blood pressure lowering medications or ≥180 mmHg irrespective of treatments, on 2 consecutive measurements at 5-minute intervals, at Visit 1 or at Visit 2.
6.MI, unstable angina, coronary revascularization (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)), ablation of atrial flutter/fibrillation, valve repair/replacement within 12 weeks prior to enrolment. Before enrolment, these patients must have their qualifying echocardiography and/or cardiac MRI examination at least 12 weeks after the event.
7.Planned coronary revascularization, ablation of atrial flutter/fibrillation and valve repair/replacement.
8.Stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment.
9.Probable alternative or concomitant diagnoses which in the opinion of the investigator could account for the patient's HF symptoms and signs (e.g. anaemia, hypothyroidism).
10.Body mass index >50 kg/m2.
Further exclusion criteria may apply

Principal Investigator: Modele Ogunniyi MD, MPH 
Research Coordinator: Senait Asier
Status: Recruiting

EMPULSE: EMPagliflozin 10 mg compared to placebo, initiated in patients hospitalized for acUte heart faiLure (de novo or decompensated chronic HF) who have been StabilisEd

Sponsor: Boehringer Ingelheim

Purpose: To assess whether in-hospital administration of empagliflozin results in improvement in HF-related outcomes (clinical benefit including death, heart failure events (HFE) and the burden of symptoms and physical limitations.

Inclusion Criteria:

• Currently hospitalised for the primary diagnosis of acute heart failure (de novo or decompensated chronic HF), regardless of ejection fraction (EF). Patients with a diagnosis of hospitalized heart failure must have HF symptoms at the time of hospital admission
• Evidence of left ventricular ejection fraction (LVEF, either reduced or preserved EF) as per local reading preferably measured during current hospitalisation or in the 12 months prior to randomisation
• Patients must be randomised after at least 24 hours and no later than 5 days after admission, as early as possible after stabilization and while still in hospital
• Patients must fulfil the following stabilisation criteria (while in the hospital):
  • SBP ≥100mm Hg and no symptoms of hypotension in the preceding 6 hours,
  • no increase in i.v. diuretic dose for 6 hours prior to randomisation,
  • no i.v. vasodilators including nitrates within the last 6 hours prior to randomisation
  • no i.v. inotropic drugs for 24 hours prior to randomisation.
• Elevated NT-proBNP ≥ 1600pg/mL or BNP ≥400 pg/mL according to the local lab, for patients without atrial fibrillation (AF); or elevated NT-proBNP ≥ 2400pg/mL or BNP ≥600 pg/mL for patients with AF, measured during the current hospitalization or in the 72 hours prior to hospital admission,. For patients treated with an angiotensin receptor neprilysin inhibitor (ARNI) in the previous 4 weeks prior to randomisation, only NT-proBNP values should be used
• HF episode leading to hospitalisation must have been treated with a minimum dose of 40 mg of i.v. furosemide (or equivalent i.v. loop diuretic defined as 20 mg of torasemide or 1 mg of bumetanide)

Further Inclusion Criteria Apply

Exclusion Criteria:

• Cardiogenic shock
• Current hospitalisation for acute heart failure primarily triggered by pulmonary embolism, cerebrovascular accident, or acute myocardial infarction (AMI)
• Current hospitalisation for acute heart failure not caused primarily by intravascular volume overload;
• Below interventions in the past 30 days prior to randomisation or planned during the study:
  • Major cardiac surgery, or TAVI (Transcatheter Aortic Valve Implantation), or PCI, or Mitraclip
  • All other surgeries that are considered major according to investigator judgement
  • Implantation of cardiac resynchronisation therapy (CRT) device
  • Cardiac mechanical support implantation
  • Carotid artery disease revascularisation (stent or surgery)
• Acute coronary syndrome / myocardial infarction, stroke or transient ischemic attack (TIA) in the past 90 days prior to randomisation
• Heart transplant recipient, or listed for heart transplant with expectation to receive a transplant during the course of this trial (according to investigator judgement), or planned for palliative care for HF, or currently using left ventricular assist device (LVAD) or intra-aortic balloon pump (IABP) or any other type of mechanical circulatory support, or patients on mechanical ventilation, or patients with planned inotropic support in an outpatient setting
• Haemodynamically significant (severe) uncorrected primary cardiac valvular disease planned for surgery or intervention during the course of the study (note: secondary mitral regurgitation or tricuspid regurgitation due to dilated cardiomyopathy is not excluded unless planned for surgery or intervention during the course of the study)
• Impaired renal function, defined as eGFR < 20 mL/min/1.73 m2 as measured during hospitalization (latest local lab measurement before randomisation) or requiring dialysis
• Type 1 Diabetes Mellitus (T1DM)
• History of ketoacidosis, including diabetic ketoacidosis (DKA)
• Further Exclusion Criteria Apply

Principal Investigator: Modele Ogunniyi MD, MPH 
Research Coordinator: Senait Asier
Status: Recruiting

Granulocyte Macrophage Stimulating Factor (GM-CSF) in Peripheral Artery Disease

Sponsor:  NIH: NHLBI

Purpose:  This study is investigating whether GM-CSF (granulocyte-macrophage colony stimulating factor or Sargramostim) improves symptoms and blood flow in people with Peripheral Artery Disease (PAD). More information about this study

Inclusion Criteria:

• Angiographically documented PAD.
• Clinically stable (>2 months) history of intermittent claudication or walking impairment (Rutherford Class II) with no change in symptom severity in the 2 months prior to screening.
• On stable statin therapy for previous 3 months.
• Peak Walking Time (PWT) between 1 and 12 minutes on a standardized Gardner treadmill protocol. 
• A Doppler-derived ankle-brachial index (ABI) of < 0.90 in the symptomatic limb after 10 minutes of rest at screening.  For subjects with an ABI of >1.3 (non-compressible arteries) a Toe-Brachial Index (TBI) of < 0.70 must be obtained for subject qualification, or if ABI is > 0.9 to 1.0 , and a reduction of 20% in ABI measured within 1 minute of treadmill testing. 
• On appropriate and stable medical therapy for atherosclerosis for > 2 months.

Principal Investigator: Arshed Quyyumi, MD
Research Coordinator: Kiran Ejaz
Status: Recruiting 

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Intravenous FDY 5301 in Patients With an Anterior ST-Elevation Myocardial Infarction

Purpose: The purpose of this study is to evaluate the efficacy and safety of FDY-5301 compared to placebo on cardiovascular clinical outcomes in subjects with an anterior ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (pPCI).

Inclusion Criteria: 

1. Age ≥ 18 years

2. Anterior STEMI, based on:

   Symptoms of myocardial ischemia (such as chest pain, shortness of breath, jaw pain, arm pain, diaphoresis, or any anginal equivalent) and

   ECG criteria:

   • men > 40 years: ≥ 2 mm of ST elevation in V2 and V3
   • men ≤ 40 years: ≥ 2.5 mm of ST elevation in V2 and V3
   • women ≥ 1.5 mm of ST elevation in V2 and V3
3. Planned primary PCI to occur ≤ 6 hours of onset of first symptoms of myocardial ischemia
4. Institutional Review Board (IRB) / Independent Ethics Committee (IEC) approved consent obtained for study participation

Principal Investigator: Arshed A. Quyyumi, MD

Research Coordinator: Kiran Ejaz

Status: Recruiting 

Specimen Collection for the Evaluation of Alere NT-proBNP for Alinity i System in an Emergency Deparment Setting for Heart Failure

Sponsor: Abbott Laboratories

Purpose: The objective of this study is to collect and bank K2-ethylenediaminetetraacetic acid (K2EDTA) plasma to evaluate the clinical utility of the Alere NT-proBNP for Alinity i system assay as an aid in the diagnosis and assessment of severity of individuals suspected or having heart failure.

Principal Investigator: Arshed Quyyumi, MD

Research Coordinator: Muhammad Owais

Status: Recruiting

Mental Stress Ischemia - Mechanisms and Prognosis

Sponsor: National Institutes of Health

Purpose: The NIH-funded Mental Stress Ischemia Study is the first comprehensive attempt to clarify pathophysiology of mental stress ischemia (MSI) and its prognosis. The study’s 3 projects examine brain, genetic, vascular, hormonal, and behavioral correlates of MSI and their influence on future cardiac events.  

Project 2, Aim 2 (the “Cath-Lab Sub-study”) attempts to evaluate the relationship between mental stress and arterial wall shear stress, endothelial function and atherosclerosis.

Patients with history of angiographically-proven or suspected Coronary Artery Disease (age 30 - 80) undergoing a clinically indicated diagnostic heart catheterization are invited to participate in the study.

In addition to standard diagnostic angiography, a wire will be placed inside an unblocked coronary artery to measure blood flow before and after mental stress (using standardized mental stress testing scenarios) as well as following infusion of intracoronary acetylcholine, adenosine and nitro. An intravascular ultrasound  is used to assess plaque characteristics/severity of any blockages and help calculate wall shear stress. This test will add about 20-30 minutes to your angiogram procedure.

Inclusion Criteria:

• Age: Between 30 and 80 years old (Must have at least 1 of the criteria 2-6)
• Angiographically proven disease including at least 1 major vessel with evidence of disease but with no specific minimum lumen diameter criteria
• Previous myocardial infarction (>1 month) documented by typical elevation of enzymes, pain or ECG changes
• Abnormal coronary intravascular ultrasound exam (IVUS) demonstrating atherosclerosis of at least 1 vessel
• Post coronary bypass surgery or percutaneous intervention (>1 year after complete revascularization)
• Positive nuclear scan or stress exercise test

Status: Completed

Mental Stress Ischemia: Biofeedback Study (MIBS)

Purpose: The purpose of this study is to evaluate the blood flow to the heart during stress and assess changes in blood flow after psychological treatment in participants with coronary artery disease. This is a randomized controlled study. The aims of the study are to assess the effects of heart rate variability (HRV) biofeedback (versus usual care) on global and regional myocardial blood flow (MBF), peripheral vascular function, and autonomic changes during mental stress.

All participants will undergo myocardial flow/perfusion imaging with positron emission tomography (PET) imaging at rest and after a standardized arithmetic mental stress test. Participants will then undergo repeat testing after 6 weeks. At 12 weeks, participants will also undergo a limited examination without myocardial perfusion imaging. The intervention group will receive biofeedback after enrollment, and the wait-list control group will receive the intervention between week 6 and week 12 study visits (without imaging).

Inclusion Criteria: 
Prior participation in the Mental Stress Ischemia: Mechanisms and Prognosis (MIPS) study

Status: Completed

Use of Biomarker Risk Score to Optimize Therapy in Patients with Coronary Artery Disease: The Precision CAD Trial

Purpose: The purpose of this study is to see if a customized treatment based on biomarkers will reduce the biomarker levels and lead to lower risk of complications from CAD.

Inclusion Criteria:

• individuals aged 21-90 years with stable CAD.
• Patients with plaque at angiography exceeding >50% in one or more coronary arteries at any time will be eligible. Current obstructive CAD is not required for eligibility.
• Patients undergoing revascularization therapy or recent acute coronary syndrome (ACS) will be eligible for recruitment and will be recruited at least 4 weeks after admission for an ACS or percutaneous intervention and 3 months after coronary bypass graft surgery.

Principal Investigator: Arshed A. Quyyumi, MD

Research Coordinator: Adetayo Adeboye

Status: Recruiting

A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF CK3773274 IN ADULTS WITH SYMPTOMATIC HYPERTROPHIC CARDIOMYOPATHY AND LEFT VENTRICULAR OUTFLOW TRACT OBSTRUCTION

Purpose: The purpose of this study is to evaluate the efficacy and safety of aficamten (CK-3773274) in adults with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction

Inclusion Criteria:

• Males and females between 18 and 85 years of age, inclusive, at screening.
• Body mass index <35 kg/m2.

• Diagnosed with HCM per the following criteria:

  • Has LV hypertrophy and non-dilated LV chamber in the absence of other cardiac disease and

  • Has an end-diastolic LV wall thickness as measured by the echocardiography core laboratory of:

    • ≥15 mm in one or more myocardial segments OR
    • ≥13 mm in one or more wall segments and a known-disease-causing gene mutation or positive family history of HCM
• Has resting LVOT-G ≥30 mmHg and post-Valsalva LVOT G ≥50 mmHg during screening as determined by the echocardiography core laboratory.
• LVEF ≥60% at screening as determined by the echocardiography core laboratory.
• NYHA Functional Class II or III at screening.
• Hemoglobin ≥10g/dL at screening.
• Respiratory exchange ratio (RER) ≥1.05 and pVO2 <80% predicted on the screening CPET per the core laboratory.
• Patients on beta-blockers, verapamil, diltiazem, or disopyramide should have been on stable doses for >6 weeks prior to randomization and anticipate remaining on the same medication regimen during the trial. Patients treated with disopyramide must also be concomitantly treated with a beta blocker and/or calcium channel blocker.

Principal Investigator: Ozlem Bilen, MD

Research Coordinator: Rasika Katare

Status: Recruiting

 

Smartphone Delivered In-home Cardiopulmonary Rehabilitation

Purpose: The goal of this study is to determine if a remote cardiac or pulmonary rehabilitation program delivered via a smartphone application and regular telephone calls will lead to improved patient outcomes as measured by functional capacity, improved patient compliance in monitoring symptoms and medication adherence, improved self-efficacy and knowledge in managing disease and, a decreased rate of hospitalization and re-admissions.

Inclusion Criteria: 

1. Following acute myocardial infarction (within the preceding 12 months)
2. Coronary artery bypass grafting (CABG)
3. Current stable angina pectoris
4. Heart valve repair or replacement
5. Percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting
6. Heart or heart-lung transplant
7. Other diagnosis by specific physician referral

Principal Investigator: Amit Shah, MD, MSc

Status: Recruiting

Smartphone-Enabled Supervised Exercise Therapy for the Treatment of Symptomatic Peripheral Arterial Disease

Purpose: The study aim is to evaluate the effectiveness of a coached, smartphone-enabled exercise program versus physician directed exercise therapy (usual care).

Inclusion Criteria:
•Clinically stable intermittent claudication
•Able to give informed consent
•Age 18-89 years

And one of the following:
•ABI < 0.9 after 10 minutes of rest OR
•For subjects with an ABI of >1.3 (non-compressible arteries) a Toe-Brachial Index (TBI) of < 0.70 must be obtained for subject qualification. If ABI is > 0.9 to 1.0, a reduction of 20% in ABI must be measured within 1 minute of treadmill testing.

Principal Investigator: Amit Shah, MD, MSc

Status: Recruiting

Evaluating the Impact of SomaSignal Tests on Medical Management and Change in Risk in Patients With Type 2 Diabetes at Higher Risk of Cardiovascular Disease

Purpose: This study is being done to evaluate the use of a new test for the management and treatment of patients who are at high risk of heart disease. The test, called a "SomaSignal Test", makes use of personalized proteomics.

Inclusion Criteria: 

• Male and female participants 40 years and older
• Diagnosis of T2D [according to American Diabetes Association (ADA) guidelines]
• Able to provide consent
• Eligible for (per drug label/guidelines) at least one of the following drug classes: sodium-glucose cotransporter 2 inhibitors (SGLT2i), proprotein convertase subtilisin/kexin type 9 (PCSK9i), glucagon-like peptide receptor agonists (GLP-1 RA) but not currently prescribed any of these classes of drugs, or only prescribed PCSK9i

Principal Investigator: Arshed A. Quyyumi, MD

Research Coordinator: Ayman Alkhoder

Status: Recruiting