Cardiology: Clinical Research Program

Cardiology: Clinical Studies Open For Enrollment

• PROTOCOL CY 6022 AN OPEN-LABEL STUDY OF CK3773274 FOR PATIENTS WITH SYMPTOMATIC HYPERTROPHIC CARDIOMYOPATHY (HCM)
• Observational Study Protocol CV027-012 DELIVER INSIGHTS IN HYPERTROPHIC CARDIOMYOPATHY AND OBSERVATIONAL OUTCOMES IN REAL WORLD (DISCOVER-HCM): UNITED STATES PROSPECTIVE REGISTRY STUDY
  
• A multi-center, randomized, double-blind, placebo-controlled, parallel-group Phase IIIb study evaluating the effect of inclisiran on atherosclerotic plaque progression assessed by coronary computed tomography angiography (CCTA) in participants with a diagnosis of non-obstructive coronary artery disease without previous cardiovascular events (VICTORION-PLAQUE).
• A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate Mavacamten in Adults with Symptomatic Non-obstructive Hypertrophic Cardiomyopathy
• Sponsor-Initiated OCS Heart Perfusion (OHP-II) Registry
• A randomized, double-blind, placebo-controlled multicenter study to evaluate the effect of inclisiran on preventing major adverse cardiovascular events in high-risk primary prevention patients (VICTORION-1 PREVENT)
• A Prospective Randomized Multicenter Global Study Comparing Pulsed Field Ablation versus Anti-Arrhythmic Drug Therapy as a First Line Treatment for Persistent Atrial Fibrillation
• A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Retatrutide on the Incidence of Major Adverse Cardiovascular Events and the Decline in Kidney Function in Participants with Body Mass Index ≥27 kg/m2 and Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease
• A Phase 3, Randomized, Double-blind, Placebo-controlled, Event-driven Study to Demonstrate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, After a Recent Acute Coronary Syndrome
• A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF AFICAMTEN COMPARED TO PLACEBO IN ADULTS WITH SYMPTOMATIC NON-OBSTRUCTIVE HYPERTROPHIC CARDIOMYOPATHY
• A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of JK07 in Adults With Chronic Heart Failure (RENEU-HF)

 

PROTOCOL CY 6022 AN OPEN-LABEL STUDY OF CK3773274 FOR PATIENTS WITH SYMPTOMATIC HYPERTROPHIC CARDIOMYOPATHY (HCM)

Eligibility

• Symptomatic Hypertrophic cardiomyopathy
• Any acute or serious comorbid
  

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04848506

Principal Investigator

Dr. Srihari Naidu

Contact for Study Screening

Rajkumari.Bhardwaj@wmchealth.org

 

Observational Study Protocol CV027-012 DELIVER INSIGHTS IN HYPERTROPHIC CARDIOMYOPATHY AND OBSERVATIONAL OUTCOMES IN REAL WORLD (DISCOVER-HCM): UNITED STATES PROSPECTIVE REGISTRY STUDY

Eligibility

• Diagnosis of obstructive Hypertrophic cardiomyopathy
  

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT05489705

Principal Investigator

Dr. Srihari Naidu

Contact for Study Screening

Rajkumari.Bhardwaj@wmchealth.org

 

A multi-center, randomized, double-blind, placebo-controlled, parallel-group Phase IIIb study evaluating the effect of inclisiran on atherosclerotic plaque progression assessed by coronary computed tomography angiography (CCTA) in participants with a diagnosis of non-obstructive coronary artery disease without previous cardiovascular events (VICTORION-PLAQUE).

Eligibility

• Male or female ≥18 years or ≤80 years of age
• Fasting LDL-C local lab value at the Screening Visit of either i) ≥100 mg/dL.
• Presence of coronary artery plaque with visual diameter stenosis <50% or Coronary artery plaque with visual artery stenosis >50% by (CCTA or coronary angiography).
• Participants must be on a stable (≥4 weeks) dose of maximally tolerated statin therapy.
• No previous cardiovascular events history including myocardial infarction (MI), nor prior coronary revascularization [percutaneous coronary intervention (PCI), nor coronary artery bypass graft (CABG)]; No uncontrolled severe hypertension either Heart failure New York Heart Association (NYHA) class III or class IV.
  

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT05360446

Principal Investigator

Hasan Ahmad, MD

Contact for Study Screening

Rajkumari.Bhardwaj@wmchealth.org

 

A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate Mavacamten in Adults with Symptomatic Non-obstructive Hypertrophic Cardiomyopathy

Eligibility

• Male or female at least 18 years of age
• Diagnosis of HCM- hypertrophic cardiomyopathy
• New York Heart Association (NYHA) Class II or III
• CPET: Documented oxygen saturation at rest > 90% at screening
  

Enrollment Status: Enrolling

Principal Investigator

Srihari Naidu, MD

Study Information

ClinicalTrialsRegister.eu | 2021-005329-26

Contact for Study Screening

Rajkumari.Bhardwaj@wmchealth.org

 

Sponsor-Initiated OCS Heart Perfusion (OHP-II) Registry

Eligibility

• Male or female at least18 years of age
• All heart transplant recipients who are transplanted with an Organ Care System (OCS) perfused donor heart are eligible for this registry.
  

Enrollment Status: Enrolling

Principal Investigator

Suguru Ohira, MD

Study Information

ClinicalTrials.gov | NCT05915299

Contact for Study Screening

Corazon.DeLaPena@wmchealth.org

 

A randomized, double-blind, placebo-controlled multicenter study to evaluate the effect of inclisiran on preventing major adverse cardiovascular events in high-risk primary prevention patients (VICTORION-1 PREVENT)

Eligibility

• Male or female ≥40 but <80 years of age
• At an increased risk for a first MACE (i.e., no prior major ASCVD event), defined as any one of the following:
  • Evidence of atherosclerotic CAD on CT or invasive coronary angiogram defined as a coronary artery stenosis ≥20% but <50% in the left main coronary artery or a stenosis ≥20% but <70% in any other major epicardial coronary artery
  • Coronary artery calcium (CAC) score obtained by CT-scan ≥100 Agatston units - determined at any time before the screening visit
  • High 10-year ASCVD risk ≥20%
  • Intermediate 10-year ASCVD risk 7.5% - <20% with at least 2 risk-enhancing factors.
• Exclusion criteria:
  • History of major ASCVD event defined as any one of the following: 
    • Acute coronary syndrome (ACS) in the 12 months prior to randomization
    • Prior myocardial infarction at any time prior to randomization
    • Prior ischemic stroke at any time prior to randomization
    • Symptomatic peripheral artery disease (PAD) as evidenced by either intermittent claudication, previous revascularization, or amputation due to atherosclerotic disease at any time prior to randomization
  • History of, or planned, ischemia-driven revascularization in a coronary or extracoronary arterial bed prior to randomization
  • Absence of coronary atherosclerosis on a CT angiogram or an invasive coronary angiogram in the 2 years prior to randomization
  • Coronary artery calcium (CAC) score of 0 obtained in the 2 years prior to randomization
  • Active liver disease or hepatic dysfunction
  • Current or planned renal dialysis or transplantation
  • Previous (within 90 days prior to the screening visit), current, or planned treatment with a mAb directed toward PCSK9 (e.g., evolocumab, alirocumab)
  • Previous exposure to inclisiran or any other non-mAb PCSK9-targeted therapy, either as an investigational or marketed drug within 2 years prior to randomization
    

Enrollment Status: Enrolling

Principal Investigator

Hasan Ahmad, MD

Study Information

ClinicalTrials.gov | NCT05739383

Contact for Study Screening

Rajkumari.Bhardwaj@wmchealth.org

 

A Prospective Randomized Multicenter Global Study Comparing Pulsed Field Ablation versus Anti-Arrhythmic Drug Therapy as a First Line Treatment for Persistent Atrial Fibrillation

Eligibility

• Age ≥ 18 years of age, or older if specified by local law
• Have symptomatic persistent AF, confirmed by both:
  • Documentation, within 180 days of randomization, or treatment assignment for roll-in subjects, of either: i. A 24-hour continuous ECG recording (from any regulatory cleared rhythm monitoring device) confirming continuous AF, OR ii. Two ECGs (from any regulatory cleared rhythm monitoring device) showing continuous AF taken at least 7 days apart
• Willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center
• Willing to receive LUX-Dx™ insertable cardiac monitor (ICM) during the study or already has a LUX-Dx™ ICM that was inserted ≤ 6 months of consent
• Exclusion criteria:
  • Over the 6 months preceding enrollment, more than 7-day history of therapeutic AAD use (Class I or III), or ≥ 24 hours amiodarone, except for pill-in-the-pocket AAD use, which is permitted. Or, treated with AAD > 6 months preceding enrollment and experienced AAD failure (adverse drug effects or frequent AF episodes)
  • Any of the following atrial conditions:
    • Left atrial (LA) anteroposterior diameter ≥ 5.5 cm, or, if LA diameter not available, non-indexed volume >100 ml, as documented by physician note or imaging (Note: if both values are available, only the LA diameter will be used to confirm eligibility criteria)
    • Any prior atrial endocardial, epicardial or surgical ablation procedure for arrhythmia, other than right sided cavotricuspid isthmus ablation or for right sided supraventricular tachycardia
    • Current atrial myxoma
    • Any PV abnormality, stenosis, or stenting (common and middle PVs are admissible)
    • Current left atrial thrombus
  • Any of the following cardiovascular conditions:
    • History of sustained ventricular tachycardia or any ventricular fibrillation
    • AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes
    • Current or anticipated pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices, interatrial baffle, atrial septal patch, atrial septal defect closure device, or patent foramen ovale occlude
    • Hypertrophic cardiomyopathy
    • Cardiac amyloidosis
      

Enrollment Status: Enrolling

Principal Investigator

Gunjan Shukla, MD

Study Information

ClinicalTrials.gov | NCT06096337

Contact for Study Screening

Danielle.Hansen@wmchealth.org

 

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Retatrutide on the Incidence of Major Adverse Cardiovascular Events and the Decline in Kidney Function in Participants with Body Mass Index ≥27 kg/m2 and Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease

Eligibility

• Male or female, 18 Years and older (Adult, Older Adult)
• Have a BMI >27.0 kg/m2 at screening (Visit 1)
• With or without T2D
• Have established ASCVD and/or CKD based on the participants’ records, including at least 1 of the following:
  • Coronary artery disease
  • Cerebrovascular disease
  • Peripheral arterial disease
  • Chronic kidney disease
• Exclusion criteria:
  • History of major ASCVD event defined as any one of the following:
  • Have T1D or history of diabetic ketoacidosis
  • Currently receiving, planning to receive, or in need of treatment, that is, intravitreal injections of Vascular Endothelial Growth Factor or steroids, focal/grid macular laser surgery, panretinal photocoagulation, or vitrectomy for diabetic retinopathy at screening (Visit 1) or in the period between screening and randomization (Visit 2)
  • Have had 1 or more episode of severe hypoglycemia or impaired awareness of hypoglycemia ≤90 days before screening (Visit 1)
    

Enrollment Status: Enrolling

Principal Investigator

Pratik Mondal, MD & Ellis Lader, MD

Study Information

ClinicalTrials.gov | NCT05882045

Contact for Study Screening

Martha.Meyer@wmchealth.org

 

A Phase 3, Randomized, Double-blind, Placebo-controlled, Event-driven Study to Demonstrate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, After a Recent Acute Coronary Syndrome

Eligibility

• Male or female ≥18 years of age.
• Participants must have an index event that meets all 3 of the following criteria within 7 days prior to randomization:
  • Clinical syndrome consistent with spontaneous cardiac ischemia
  • Diagnosis of ACS (i.e., STEMI, non-STEMI, or UA)
  • Cardiac biomarker elevation (e.g., troponin I, troponin T, CK-MB) above the upper limit of normal as determined by the local laboratory
• Participants must have at least 2 of the following risk factors:
  • Age 65 or older
  • Diabetes mellitus
  • History of a prior MI
• All female participants of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin (hCG) or urine test at screening
• A female participant must not be pregnant, breastfeeding, or planning to become pregnant until 4 days (5 half-lives) after the last dose of study intervention
• Exclusion criteria:
  • MI secondary to ischemia due to either increased oxygen demand or decreased supply (Type 2 MI) or periprocedural MI as the index ACS event
  • Minimal or no obstructive CAD on angiography performed for the index ACS event prior to any PCI (i.e., <50% stenosis visually as determined by the investigator).
  • Planned CABG or staged PCI after randomization (Note: participants may be evaluated for enrollment after completion of a planned staged PCI).
  • Any condition that requires chronic anticoagulation at the discretion of the investigator and/or local guidelines. Note: Participants with an indication for chronic antiplatelet therapy after placement of a bio-prosthetic non-mechanical valve (eg, transcatheter aortic valve replacement) do not satisfy this exclusion criterion and are eligible for study participation.
  • Conditions with a significant increased risk of bleeding (e.g., clinically significant bleeding within previous 3 months, known bleeding diathesis, etc.)
    

Enrollment Status: Enrolling

Principal Investigator

Jain Diwakar, MD

Study Information

ClinicalTrials.gov | NCT05754957

Contact for Study Screening

Rajkumari.Bhardwaj@wmchealth.org

 

A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF AFICAMTEN COMPARED TO PLACEBO IN ADULTS WITH SYMPTOMATIC NON-OBSTRUCTIVE HYPERTROPHIC CARDIOMYOPATHY

Eligibility

• Male or female, Between 18–85 years of age at screening
• Body mass index < 40 kg/m2 
• Diagnosed with nHCM and has a screening echocardiogram with the following:
  • End-diastolic LV wall thickness:
    • ≥ 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 AND
    • Resting LVOT-G < 30 mmHg AND Valsalva LVOT-G < 50 mmHg AND
    • LVEF ≥ 60%
  • Participants with a history of intracavitary obstruction are eligible.
• NYHA class II or III
• Respiratory exchange ratio of ≥ 1.00 at screening by CPET and predicted peak oxygen uptake (pVO2) of ≤ 90% for age and sex
• KCCQ-CSS score of ≥ 30 and ≤ 85
• N-terminal prohormone brain natriuretic peptide (NT-proBNP) of:
  • ≥ 300 pg/mL or ≥ 900 pg/mL if in atrial fibrillation or atrial flutter OR
  • For Black participants, ≥ 225 pg/mL or ≥ 675 pg/mL if in atrial fibrillation or atrial flutter
• Hemoglobin ≥ 10 g/dL
• Participants on beta-blockers, verapamil, diltiazem, or ranolazine should have been on stable doses for ≥ 2 weeks prior to screening CPET and anticipate remaining on the same medication regimen during the study
• Exclusion criteria:
  • Significant valvular heart disease (per Investigator judgment)
    • Moderate or severe valvular aortic stenosis or fixed subaortic obstruction
    • Moderate or severe mitral regurgitation
  • Known or suspected infiltrative, genetic or storage disorder causing cardiac hypertrophy that mimics nHCM (e.g., Noonan syndrome, Fabry disease, amyloidosis)
  • Known current unrevascularized coronary artery stenosis of ≥ 70% or documented history of myocardial infarction
  • History of LV systolic dysfunction (LVEF < 45%) or stress cardiomyopathy
  • Inability to exercise on a treadmill or bicycle (e.g., orthopedic limitations)
  • Documented room air oxygen saturation reading < 90% at screening or history of significant chronic obstructive pulmonary disease or severe/significant pulmonary hypertension
  • History of syncope, symptomatic ventricular arrhythmia, or sustained ventricular tachyarrhythmia with exercise within 3 months prior to screening
    

Enrollment Status: Enrolling

Principal Investigator

Srihari Naidu, MD

Study Information

ClinicalTrials.gov | NCT06081894

Contact for Study Screening

Rajkumari.Bhardwaj@wmchealth.org

 

A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of JK07 in Adults With Chronic Heart Failure (RENEU-HF)

Eligibility

• Male or female, Between 18–85 years of age 
• Participants with New York Heart Association (NYHA) Class II-III
  • Cohort 1 - Left Ventricular Ejection Fraction (LVEF) ≤ 40%
  • Cohort 2 - Left Ventricular Ejection Fraction (LVEF) >40% and ≤ 65%, elevated N-terminal pro B-type natriuretic peptide (NT-proBNP) ≥ 600pg/mL and atrial fibrillation/flutter
• Stable HF defined as no hospitalizations for cardiac-related issues within 4 weeks prior to the initial screening visit or between screening and randomization, other than for routine percutaneous procedures such as device battery/generator changes or new pacemaker lead insertion
• Participants should be established on background optimal medical therapy for HF and be treated according to locally recognized guidelines with both drugs and devices, as appropriate
• Screening hemoglobin ≥ 9.0 g/dL
• Exclusion criteria:
  • Uncontrolled hypertension
  • Sustained systolic Blood Pressure (BP) < 90 mmHg and/or diastolic BP < 50 mmHg on 2 consecutive (duplicate seated) readings at screening
  • Heart failure due to hypertrophic cardiomyopathy, restrictive and/or infiltrative cardiomyopathy, arrhythmogenic right ventricular dysplasia, Fabry disease, or Noonan syndrome with LV hypertrophy or a positive serum immunofixation result
  • Diagnosis of stress-induced (Takotsubo) cardiomyopathy, myocarditis, or peripartum cardiomyopathy
  • Diagnosis of chemotherapy- or radiation-induced cardiomyopathy
  • Diagnosed with stroke or Transient Ischemic Attack (TIA) within 12 weeks of screening
  • History of syncope within the last 12 weeks prior to screening or sustained ventricular tachycardia without an implantable cardioverter-defibrillator
  • Moderate or severe aortic and/or mitral valve stenosis
  • Medically documented unstable angina, acute coronary syndrome (e.g., myocardial infarction, troponin-positive with symptoms of angina or unstable angina) within the last 8 weeks prior to start of screening
  • Medically documented ST-elevation myocardial infarction within 12 weeks of screening.
  • Any narrow complex tachycardia (inclusive of atrial fibrillation or atrial flutter) with a resting ventricular rate > 110 beats per minute at screening
  • For participants with a history of AF or atrial flutter, not on adequate anticoagulant therapy via non-vitamin K oral anticoagulants or warfarin if the CHA2DS2-VASc score is ≥ 2 in men or ≥ 3 in women or per local guidelines
  • AF ablation within the last 12 weeks prior to screening or planned during the study duration
  • Symptomatic bradycardia or second (Mobitz Type II)- or third-degree heart block without a pacemaker
    

Enrollment Status: Enrolling

Principal Investigator

Stephen Pan, MD

Study Information

ClinicalTrials.gov | NCT06369298

Contact for Study Screening

Rajkumari.Bhardwaj@wmchealth.org