Cardiology: Clinical Research Program

Banner

Cardiology: Clinical Studies Open For Enrollment


 

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