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
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
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
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
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
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
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