ONGOING STUDIES


CHaRM INVESTIGATOR GROUP: Contracted Research, Clnical Trials & Non-Interventional Study, Actively recruiting

Clinical Trials, Actively Recruiting

LAAOS III

Left Atrial Appendage Occlusion Study III
Dr. R. Singal Dr.s Menkis, Pascoe, Warrian, Raabe
Sponsor PHRI

Objective
The primary objective is to examine the impact of LAA occlusion on the incidence of stroke or systemic arterial embolism in patients with atrial fibrillation undergoing cardiac surgery with the use of cardiopulmonary bypass over the duration of follow-up.

Inclusion: Adult patients undergoing cardiac surgery (clinically indicated) who have a history of atrial fibrillation/flutter.

Exclusion: Study Team will assess

Wendy Janz RN and Charissa Cepidoza (Research Assistant)
Contact Numbers (204) 237-2793 or (204) 258-4099

CTA-HF

Imaging Modalities to Assist with Guiding therapy and the Evaluation of patients with Heart Failure (IMAGE-HF) Part 1-C: Computed Tomographic Coronary Angiography for Heart Faailure Patients (CTA-HF)
Dr. M. Kass
Dr. Cordova

To evaluate the clinical utility of computed tomographic coronary angiography (CTA) and investigate its potential benefit on resource utilization and health economics in patients with progressive or newly diagnosed heart failure (HF) of unknown etiology (i.e. ischemic versus non-ischemic) or in whom the definition of coronary anatomy is required for diagnosis and management. The experimental algorithm will be compared to invasive coronary angiography (ICA)

Inclusion: Eligible Heart Failure (HF) patients with documented history of Class ll-lV heart failure symptoms in the preceding 12 months prior to enrollment, in whom the diagnosis of Coronary Artery Disease (CAD) is uncertain or the definition of coronary anatomy is required for diagnosis and management.

Exclusion: Atrial fibrillation, frequent atrial or ventricular ectopy (> 1 / minute);

Wendy Janz RN and Charissa Cepidoza (Research Assistant)
Contact Numbers (204) 237-2793 or (204) 258-4099


Resveratrol: a potential anti-remodeling agent in heart failure, from bench to bedside

Dr. A. Malik
Dr. Zieroth, Tappia, and Netticadan

The objective of the proposed study is to examine the effects of resveratrol on clinical echocardiographic and biochemical parameters in patients with non-ischemic cardiomyopathy.

Inclusion:
1. Non-ischemic cardiomyopathy, systolic dysfunction (defined as Left Ventricular Ejection Fraction (LVEF) <40%
2. New York Heart Association (NYHA) Functional class II-III
Exclusion: Study Team will assess

Wendy Janz RN and Charissa Cepidoza (Research Assistant)
Contact Numbers (204) 237-2793 or (204) 258-4099


SODIUM-HF

The long-term effects of dietary sodium restriction on clinical outcomes in patients with heart failure. (Study of Dietary Intervention Under 100 MMOL in Heart Failure)

Dr. Zieroth

The main objective is to evaluate the long-term effects of a low-sodium containing diet on a composite clinical outcome composed of all-cause mortality, cardiovascular hospitalizations or cardiovascular emergency department visits in patients with HF.

Inclusion: Confirmed diagnosis of HF (both reduced and preserved systolic function are eligible)
NYHA Class II-III
On optimally tolerated medical therapy according CCS guidelines

Exclusion: Study Team will assess

Wendy Janz RN and Charissa Cepidoza (Research Assistant)
Contact Numbers (204) 237-2793 or (204) 258-4099

(COMPASS - Cardiovascular OutcoMes for People using Anticoagulation StrategieS) <

A randomized controlled trial of rivaroxaban for the prevention of major cardiovascular events in patients with coronary or peripheral artery disease
Dr. R. Singal/ Dr. Guzman

1.To determine whether rivaroxaban 2.5 mg twice daily (bid) + aspirin 100 mg once daily (od) compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke, or cardiovascular death in subjects with CAD or PAD

2. To determine whether rivaroxaban 5 mg bid compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke or cardiovascular death in subjects with CAD or PAD

Inclusion: Meet criteria for CAD* and/or PAD
- Subjects with CAD must also meet at least one of the following criteria:
- Age >/= 65, or
- Age < 65 and documented atherosclerosis or revascularization involving at least 2 vascular beds,19 or at least 2 additional risk factors:
1) Current smoker (within 1 year of randomization)
2) Diabetes mellitus
3) Renal dysfunction with estimated glomerular filtration rate <60 ml/min
4) Heart failure
5) Non-lacunar ischemic stroke >/= 1 month ago
§ Because CAD involves disease in the coronary vasculature, only one additional vascular bed is required: e.g. the aorta and arterial supply to the brain, gastro-intestinal tract, lower limbs, upper limbs, or kidneys.

Exclusion:
1. High risk of bleeding
2. Stroke within 1 month or any history of hemorrhagic or lacunar stroke
3. Severe heart failure with known ejection fraction <30% or New York Heart Association (NYHA) class III or IV symptoms

Wendy Janz RN and Charissa Cepidoza (Research Assistant)
Contact Numbers (204) 237-2793 or (204) 258-4099

SPIRE 1

Phase 3 Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Evaluation Of The Efficacy, Safety, And Tolerability Of Bococizumab (Pf-04950615),
In Reducing The Occurrence Of Major Cardiovascular Events In High Risk Subjects

Spire: Studies of PCSK9 Inhibition and the Reduction of vascular Events

Dr. Nguyen
Drs Katz and Junaid
Objective

The primary objective of this clinical trial is to demonstrate the superior efficacy of bococizumab compared with placebo in reducing the risk of major CV events, a composite endpoint which includes adjudicated and confirmed CV death, non-fatal MI, non-fatal stroke, and hospitalization for unstable angina with urgent revascularization in subjects at high or very high risk of major CV events who are on background lipid lowering treatment and have an LDL-C (low density lipoprotein) >/= 70 mg/dL (1.81 mmol/L) and </= 100 mg/dL (2.59 mmol/L) or non-HDL-C (non-high density lipoprotein cholesterol) >/= 100 mg/dL (2.59 mmol/L) and </= 130 mg/dL (3.36 mmol/L).

Inclusion:
1. Have a direct LDL-C measurement of >/= 70 mg/dL (1.8 mmol/L) and </= 100 mg/dL (2.6 mmol/L) or non-HDL-C >/= 100 mg/dL (2.6 mmol/L) and </= 130 mg/dL (3.4 mmol/L)
2. Be willing and able to self-administer or be administered sub-cutaneous injections of investigational product.
3a. Have had a Myocardial infarction > 30 days and </= 5 years, prior to screening.
OR
3b. Have had an Ischemic stroke > 30 days, and </= 5 years prior to screening.
OR
3c. Have had Coronary artery revascularization > 90 days, but </= 5 years prior to screening
OR
3d. Have had Prior non-coronary arterial revascularization > 30 days, and </= 5 years prior to screening documented as a carotid, or peripheral artery revascularization, by either open surgery, endovascular catheterization, or thrombolysis, with or without stent placement.
OR
3e. Is Heterozygous familial hypercholesterolemia

Exclusion: Study Team will assess

Wendy Janz RN and Charissa Cepidoza (Research Assistant)
Contact Numbers (204) 237-2793 or (204) 258-4099

SPIRE 2

Phase 3 Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Evaluation Of The Efficacy, Safety, And Tolerability Of Bococizumab Pf-04950615, In Reducing The Occurrence Of Major Cardiovascular Events In High Risk Subjects

Dr. Nguyen
Drs Katz and Junaid

The primary objective of this clinical trial is to demonstrate the superior efficacy of bococizumab compared with placebo in reducing the risk of major CV events, a composite endpoint which includes adjudicated and confirmed CV death, non-fatal MI, non-fatal stroke, and hospitalization for unstable angina with urgent revascularization, in subjects at high or very high risk of major CV events who are on background lipid lowering treatment and have an LDL-C >/= 100 mg/dL (2.59 mmol/L) or non-HDL-C >/= 130 mg/dL (3.36 mmol/L).

Inclusion:
1. Have a direct LDL-C measurement of LDL-C >/= 100 mg/dL (2.59 mmol/L) or non-HDL-C >/= 130 mg/dL (3.36 mmol/L)
2. Be willing and able to self-administer or be administered sub-cutaneous injections of investigational product.


3a. Have had a Myocardial infarction > 30 days and </= 5 years, prior to screening.
OR
3b. Have had an Ischemic stroke > 30 days, and </= 5 years prior to screening.
OR
3c. Have had Coronary artery revascularization > 90 days, but </= 5 years prior to screening
OR
3d. Have had Prior non-coronary arterial revascularization > 30 days, and </= 5 years prior to screening documented as a carotid, or peripheral artery revascularization, by either open surgery, endovascular catheterization, or thrombolysis, with or without stent placement.
OR
3e. Is Heterozygous familial hypercholesterolemia

Exclusion: Study Team will assess

Wendy Janz RN and Charissa Cepidoza (Research Assistant)
Contact Numbers (204) 237-2793 or (204) 258-4099

LEVO-CTS

A Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Patients with Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery Requiring Cardiopulmonary Bypass

Dr. Rakesh Arora
Drs Zieroth and Singal

Primary objective is to evaluate the efficacy of levosimendan compared with placebo in reducing the co-primary endpoints of composite of all-cause death (Day 30) or use of mechanical assist (IABP, LVAD, or ECMO) (Day 5), or the composite endpoint of all-cause death (Day 30), perioperative MI (Day 5), need for dialysis (Day 30), or use of mechanical assist (IABP, LVAD, or ECMO) (Day 5) in subjects with reduced LVEF undergoing cardiac surgery on CPB.

Inclusion:

Scheduled
1) CABG
2) CABG with aortic valve
3) CABG with mitral valve surgery, or
4) isolated mitral valve surgery

Surgery will employ CPB pump

LVEF </= 35% (CABG patients) or LVEF </= 35% (CABG with valve) measured by ventriculogram, echocardiogram (ECHO), nuclear scan, or MRI within 60 days before surgery

Exclusion: Study Team will assess

Wendy Janz RN and Charissa Cepidoza (Research Assistant)
Contact Numbers (204) 237-2793 or (204) 258-4099


Contracted Research, Non-Interventional Study, Actively Recruiting

GOAL

Guidelines Oriented Approach to Lipid lowering (GOAL) in Canada
Dr. Pam Katz
Drs Nguyen and Junaid

1. To identify, describe and segment (allocate into pre-specified subgroups) high risk cardiovascular patients who do not achieve recommended LDL-C target despite optimally tolerated statin therapy.

2. To describe current treatment strategies in patients who are not achieving recommended LDL-C targets.

Inclusion:

High risk for cardiovascular morbidity and mortality (at least one of the following):

1.Clinical vascular disease
2. Diabetes Mellitus on glycemic control medication
3. Chronic Kidney Disease
4. High risk hypertension
5. FRS > 20%
6. Familial hypercholesterolemia and LDL-C >/= 2.5 mmol/L

Exclusion: Study Team will assess

Wendy Janz RN and Charissa Cepidoza (Research Assistant)
Contact Numbers (204) 237-2793 or (204) 258-4099

Contracted Research, Clinical Trials, Enrollment Ended Beta Blockers and Angiotensin Receptor Blockers in Bicuspid Aortic Valve Disease Aortopathy

Dr. James Tam

Objective
Beta Blockers and Angiotensin Receptor Blockers in Bicuspid Aortic Valve Disease Aortopathy (BAV Study)

Inclusion: Men and women with bicuspid aortic valve (BAV) and ascending aorta measuring > 37mm at end diastole in any imaging modality.

Exclusion: Study Team will assess

Wendy Janz RN and Charissa Cepidoza (Research Assistant)
Contact Numbers (204) 237-2793 or (204) 258-4099

New Studies:

Study Title: APPRISE Study
Title: A Multi-Country, Multicenter, Single-Arm, Open-Label Study to Document the Safety, Tolerability and Effect of Alirocumab on atherogenic lipoproteins in High Cardio-Vascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-Modifying Therapies
Dr. Asad Junaid
Co-I's : Dr. Thang Nguyen
Dr. Pam Katz

Objective: To provide patients with severe hypercholesterolemia at risk for subsequent cardiovascular (CV) events and not adequately controlled with currently available lipid modifying therapy (LMT) with access to alirocumab ahead of commercial availability and document the overall safety and tolerability of alirocumab in this patient population.

Inclusion:
- Patients suffering from heterozygous familial hypercholesterolemia (heFH) with LDL-C concentrations >/= 160 mg/dL (4.2 mmol/L) despite treatment
- Patients suffering from heFH with LDL-C concentrations >/= 130 mg/dL (3.4 mmol/L) despite treatment and two or more CV risk factors

- Patients suffering from heFH with LDL-C concentrations >/= 130 mg/dL (3.4 mmol/L) despite treatment and one of the following risk factors:
1. established CHD or other CVD
2. drug treated type 2 diabetes mellitus or type 1 with target organ damage
3. family history of first or second degree relative with very premature onset CHD

- Non-FH patients suffering from established CHD or other CVD (history of acute myocardial infarction, ischemic stroke, peripheral arterial disease, coronary or peripheral arterial revascularization, stable or unstable angina, transient ischemic attack, carotid artery stenosis >/= 50%, aortic abdominal aneurysm) and with LDL cholesterol concentrations >/= 130 mg/dL (3.4 mmol/L).
- Patients suffering from progressive cardiovascular disease [coronary artery disease, or peripheral arterial occlusive disease or cerebrovascular disease as documented clinically or by imaging techniques, with a subsequent CV event (acute MI, ischemic stroke, ischemia driven revascularization, unstable angina, transient ischemic attack) occurring despite stable doses of maximally tolerated LLT] with LDL cholesterol concentrations >/= 100 mg/dL (2.59 mmol/L).

Exclusion: Not on a stable dose of LMT (including statin) for at least 4 weeks prior to the screening visit (Week -3) and from screening to enrollment
Study Team will assess the rest

Wendy Janz RN and Charissa Cepidoza (Research Assistant)
Contact Numbers (204) 237-2793 or (204) 258-4099