Case Studies

Cardiology Division · Clinical Research

Advancing the Future of Heart Care

Our cardiology team participates in nationally and internationally recognized clinical trials. These studies give eligible patients access to cutting-edge treatments before they are widely available. Learn about the trials underway at our center below.

Compassionate Care. Innovative Medicine. Exceptional Outcomes.

CT Trials

BRAVEHEART

Hypertrophic Cardiomyopathy

The BRAVEHEART Registry is a prospective, single-center, observational study aimed at evaluating the prevalence and severity of coronary artery disease (CAD) in firefighters. By utilizing advanced diagnostic tools like Coronary Computed Tomography Angiography (CCTA) and Fractional Flow Reserve derived from CT (FFRct), this study will help gain a deeper understanding of the cardiac risks faced by firefighters.

Phase

Phase 3

Condition

Obstructive HCM

GAMEFILM

Cardiac Imaging Trial

The GAMEFILM Registry is a post-market, multi-center, data collection registry assessing the CAD presence and severity among NFL alumniwho are without symptoms suggestive of CAD. By utilizing advanced diagnostic tools like Coronary Computed Tomography Angiography (CCTA) and Fractional Flow Reserve derived from CT (FFRct), this study will help gain a deeper understanding of the cardiac risks faced by NFL alumni.

Type

Imaging / Observational

TRANSFORM

Cardiovascular Outcomes

TRANSFORM is designed to evaluate a novel treatment approach that may help change the long-term course of cardiovascular disease. The trial targets patients at elevated risk for serious cardiac events and tests whether early, intensive intervention can meaningfully reduce hospitalizations and improve quality of life. If you have been told you are at high risk for heart problems, you may be eligible to join this important study.

Focus

Risk Reduction

Device Trials

DENOVO DEB

Small Vessel Disease

Many patients with coronary artery disease have blockages in smaller blood vessels where placing a permanent metal stent is more challenging. This trial evaluates a drug-eluting balloon (DEB) — a specialized catheter balloon coated with a medication that prevents scar tissue from forming — as an alternative to traditional stenting. The balloon is inflated briefly to open the blocked artery and deliver the drug directly to the vessel wall, then removed, leaving nothing behind. Early evidence suggests this approach may offer comparable outcomes to stenting with fewer long-term complications.

Procedure

Minimally Invasive

Condition

Coronary Artery Disease

FIRE‑1

Heart Failure Monitoring

One of the biggest challenges in managing heart failure is detecting dangerous fluid buildup before it becomes a crisis. The FIRE-1 trial studies a small implantable sensor — about the size of a pen cap — placed in a large vein to continuously track fluid levels in the body. Once home, patients wear a comfortable belt for a few minutes each day to download readings, which are sent automatically to their care team. This allows doctors to adjust medications early, potentially preventing emergency visits. Think of it as a "fluid glucose monitor" for heart failure.

Status

Device

Implantable Sensor

Type

Heart Failure

Heart Failure Trials

CONFIRMATION

Combination Drug Therapy

CONFIRMATION-HF tests whether starting two proven heart failure medications — finerenone and an SGLT2 inhibitor — together at the time of a hospital stay leads to better long-term outcomes than current standard care. Both drugs individually have shown benefits; this trial asks whether combining them early and simultaneously gives patients a stronger head start. It is open to patients admitted to the hospital with a diagnosis of heart failure, regardless of the type of heart failure they have.

Phase

Phase 3

Setting

Hospital / Post-discharge

FINALITY

Heart Failure · Reduced EF

Some patients with heart failure and a reduced pumping function cannot tolerate the usual aldosterone-blocking medications due to side effects like elevated potassium or kidney concerns. FINALITY-HF studies whether finerenone — a newer, more selective medication in this class — offers similar heart-protective benefits with a better tolerability profile. If you have been unable to take spironolactone or eplerenone, you may be a candidate for this trial.

Phase

Phase 3

Drug

Finerenone

REDEFINE

Heart Failure · Preserved EF

REDEFINE-HF focuses on a form of heart failure where the heart squeezes normally but is too stiff to relax and fill well — known as heart failure with preserved ejection fraction (HFpEF). This condition has historically had fewer proven treatments than other heart failure types. The trial evaluates whether finerenone, taken as a once-daily pill, can reduce re-hospitalizations and cardiovascular events in patients recently discharged after a heart failure episode. Findings from this study could redefine how this common but undertreated condition is managed.

Status

Phase

Phase 3

Condition

HFpEF / HFmrEF

FIRE‑1

Remote Fluid Monitoring

Also listed under Device Trials, FIRE-1 addresses a critical unmet need in heart failure management: catching worsening fluid overload before it requires an ER visit. The sensor monitors your body's fluid status around the clock, allowing for proactive, data-driven adjustments to your care plan. Patients with a recent heart failure hospitalization or worsening symptoms may be eligible.

Status

Type

Device + Remote Monitoring

Hyperlipidemia Trial

AZURE‑15

LDL Cholesterol Reduction

High LDL ("bad") cholesterol is one of the leading drivers of heart attacks and strokes. AZURE-15 investigates a next-generation approach to lowering LDL in patients who are already on statin therapy but haven't reached their target cholesterol levels. The study drug targets a protein called PCSK9, which controls how the liver processes and removes cholesterol from the bloodstream. By blocking this protein, the medication may achieve dramatic reductions in LDL — potentially helping patients who cannot tolerate higher statin doses or need additional cholesterol control on top of existing treatment.

Target

LDL Cholesterol

Mechanism

PCSK9 Inhibition

CHOLESTEROL MEDICATION

V-INTERVENTION

Cholesterol Reduction

V-INTERVENTION is a large national research study evaluating whether Inclisiran, a cholesterol-lowering medication given as a simple injection, can reduce the risk of future heart attacks, strokes, and serious leg artery complications when started around the time a patient undergoes a heart or leg artery procedure. The study is enrolling patients who have recently had a coronary or peripheral artery revascularization procedure (such as a stent or other artery-opening treatment) to determine whether early treatment with inclisiran can improve long-term cardiovascular and vascular

Target

Cholesterol

Interested in Participating?

Joining a clinical trial is a personal decision. Our research coordinators are here to answer your questions, explain the eligibility requirements for each study, and make sure you have everything you need to make an informed choice — with no obligation.

Call: (619) 616-2100 ext 133

Important Notice: Clinical trial participation is always voluntary. Eligibility criteria vary by study. Enrollment in a trial does not replace your regular cardiology care. Please speak with your cardiologist or our research team for personalized guidance. All studies listed here are conducted under IRB oversight and in accordance with federal research regulations.