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
Erida.Castro@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
Erida.Castro@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
Anuritha.Tirumani@wmchealth.org
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
Erida.Castro@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
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
Anuritha.Tirumani@wmchealth.org