Cardiovascular disease (CVD) remains a formidable global health challenge, encompassing a spectrum of conditions that affect the Heart and blood vessels. CVD includes heart disease, heart failure, and valvular disorders, collectively contributing to significant morbidity and mortality worldwide. To combat this pervasive health threat, it is imperative to explore the pivotal role of Clinical Trials in the context of CVD prevention.

What is Cardiovascular Disease (CVD)

Cardiovascular Disease (CVD) is a comprehensive term encompassing a range of conditions that affect the heart and blood vessels. These conditions collectively pose a significant threat to global health and are responsible for a substantial portion of morbidity and mortality worldwide.

The umbrella of CVD includes:

1. Heart Disease: Often used interchangeably with CVD, heart disease refers to various conditions that affect the heart’s structure and function. This can involve issues with the heart’s valves, muscles, rhythm, or blood vessels.
2. Heart Failure: A condition in which the heart is unable to pump blood effectively, leading to a reduced ability to meet the body’s oxygen and nutrient demands.
3. Valvular Disorders: Conditions where the heart’s valves do not function correctly, causing problems with blood flow and potentially leading to complications like valve stenosis or regurgitation.
4. Atherosclerosis: A common underlying cause of many CVDs, atherosclerosis occurs when arteries become narrowed or blocked due to the buildup of fatty deposits (plaques), restricting blood flow.
5. Stroke: While not a heart condition per se, strokes often result from problems in the blood vessels leading to the brain and are closely linked to CVD.

How to Diagnose CVD

The diagnosis of CVD typically involves a combination of medical history evaluation, physical examination, and various diagnostic tests. Healthcare professionals may inquire about risk factors such as smoking, family history, diet, and exercise habits. The physical examination may include measuring blood pressure, listening to the heart and lungs, and checking for signs of heart or vascular abnormalities, such as excessive swelling in the extremities.

Key diagnostic tests for CVD include:

1. Electrocardiogram (ECG or EKG): This test records the electrical activity of the heart and helps identify irregular heart rhythms or signs of previous heart attacks.
2. Echocardiogram: Using sound waves, an echocardiogram creates images of the heart’s structure and function, aiding in the detection of structural abnormalities.
3. Blood Tests: Blood tests can reveal levels of cholesterol, triglycerides, and biomarkers associated with heart disease. Elevated levels may indicate increased risk.
4. Stress Tests: Stress tests, often done on a treadmill or with medication, monitor the heart’s response to physical activity and help diagnose conditions like coronary artery disease.
5. Cardiac Catheterization: Invasive procedures like angiography involve inserting a catheter into blood vessels to visualize blockages and assess coronary artery disease.

Current Prevention and Treatment for CVD

Preventing and treating CVD involves a multifaceted approach that addresses both lifestyle modifications and medical interventions. Current strategies include primary and secondary prevention.

1. Primary CVD prevention refers to the set of steps taken to prevent or delay the onset of cardiovascular events.
2. Secondary CVD prevention refers to using pharmacologic treatment and lifestyle changes to treat someone with already established cardiovascular disease to prevent and delay the consequences of the disease.

In 2019, the American College of Cardiology (ACC) and the American Heart Association (AHA) released the most recent Clinical practice guidelines for the primary prevention of CVD.

The main recommendations made by the task force include the following:

• Maintenance of a lifelong healthy lifestyle is the most important preventative measure to decrease the onset of CVD.
• Social determinants of health should be assessed, and treatment strategies using a team-based approach through collaboration with other clinicians, the patient, and their family, should be implemented to mitigate the risks of CVD and reach treatment goals.
• The 10-year atherosclerotic cardiovascular disease (ASCVD) risk should be calculated using the pooled cohort equation in adults between the ages of 40-75. The resultant absolute risk and the associated preventative interventions should be discussed with the patient before starting pharmacotherapy for hypertension or hyperlipidemia.
• A healthy diet, emphasizing the intake of vegetables, fruits, whole grains, legumes, low-fat dairy, poultry, and fish. Limiting foods high in cholesterol, sodium, processed meats, refined carbohydrates, and sweetened beverages was also recommended. Dietary counseling, including caloric restriction, should be provided to those diagnosed with obesity.
• Regular exercise in the form of at least 150 minutes of moderate-intensity or 75 minutes of vigorous-intensity activity per week.
• Lifestyle changes, especially dietary habits and regular exercise, for patients diagnosed with type 2 diabetes. For those for whom medication is indicated, metformin is recommended as first-line therapy, with the addition of SGLT-2 inhibitors or GLP-1 agonists as needed.
• Assessment of all adults for tobacco use. Counseling for cessation is recommended for those who use tobacco.
• Routine use of Aspirin is not recommended because of lack of evidence for benefit in ASCVD prevention. Aspirin is also contraindicated in those with an increased risk of bleeding.
• Elevations in LDL cholesterol over 190 mg/dL should be treated with statin therapy in patients diagnosed with diabetes mellitus, those who are 40 to 75 years of age, and those with a higher risk for cardiovascular disease.
• Lifestyle interventions for those diagnosed with high blood pressure. If the patient is on hypertension medication, the target blood pressure should be below 130/80 mmHg.

Why is Preventing CVD Important?

CVD, especially heart disease, has been the leading cause of death in the United States since the 1950s. During the 1980s and 1990s, steps were taken by the CDC to create resources to prevent CVD and related adverse events. As these programs were implemented, the prevalence of CVD risk factors and the number of CVD events, declined.

However, there has been a steady increase in the numbers over the past decade, with a sharp rise since the start of the COVID-19 pandemic.

This increase is attributed to several factors, including:

• Decreased follow-up with healthcare providers.
• A decline in the healthcare workforce.
• The direct impact of infection of COVID-19 on the cardiovascular system.
• A concomitant rise in the risk factors of CVD, such as obesity and diabetes.

In addition to increasing the risk of mortality, CVD and its subsequent events are also the primary cause of morbidity in the U.S. The sequelae of CVD events, including paralysis and dementia, lead to a higher risk of poor quality of life and increased healthcare costs.

Preventative efforts can help increase general cardiovascular health and mitigate these risks. Improving the cardiovascular health of adults in the U.S. is estimated to prevent 1.2-2 million major CVD events per year.

The Role of Clinical Trials in CVD Prevention

Clinical trials have emerged as a powerful tool in the fight against CVD. These controlled research studies provide invaluable insights into the prevention, treatment, and management of cardiovascular diseases. By conducting clinical trials, researchers can evaluate the effectiveness of novel interventions, medications, and lifestyle modifications in preventing CVD.

New innovations have been in the form of medical devices and pharmaceutical management of CVD. One example of a medical device clinical trial that is aimed at improving the atrial fibrillation involves a new energy source for ablation. Traditionally, cryotherapy or radiofrequency therapy has been used to treat paroxysmal atrial fibrillation. However, the new ablation technique called pulse-field ablation, uses small electrical pulses to eliminate the irregular heartbeats.

Another example of new drug management for CVD is in the study of semaglutide. Typically used for patients with type 2 diabetes, semaglutide has recently been studied in the context of cardiovascular disorders. Patients with type 2 diabetes can suffer more commonly from CVD, so issuing a drug that can impact both diabetic and CVD outcomes is advantageous.

In 2019, the American College of Cardiology (ACC) and the American Heart Association (AHA) issued updated clinical practice guidelines for primary CVD prevention. These guidelines emphasize the importance of lifelong healthy lifestyles as the cornerstone of preventing CVD. Additionally, they advocate for a comprehensive approach that addresses social determinants of health and encourages collaboration among healthcare providers, patients, and their families.

Key recommendations from these guidelines include:

• Calculating the 10-year atherosclerotic cardiovascular disease (ASCVD) risk for adults aged 40-75 and discussing the absolute risk and preventative interventions.
• Promoting a healthy diet emphasizing fruits, vegetables, whole grains, and lean proteins while limiting high-cholesterol and high-sodium foods.
• Encouraging regular exercise and lifestyle modifications, particularly for patients with type 2 diabetes.
• Assessing all adults for tobacco use and providing counseling for cessation.
• Discontinuing routine aspirin use for ASCVD prevention.
• Recommending statin therapy for individuals with elevated LDL cholesterol levels and hypertension.

Cardiology CROs: Improving Outcomes for Cardiovascular Clinical Research

Cardiology clinical trials have helped lead the way in understanding the impact of CVD and in the formation of clinical guidelines for the treatment and prevention of CVD. Further research is needed to decrease the incidence of CVD and the resultant global mortality and morbidity levels.

Cardiology Contract Research Organizations (CROs) play a pivotal role in advancing CVD prevention through clinical trials. These specialized organizations are dedicated to facilitating cardiology clinical trials, streamlining processes, and reducing costs.

Vial Cardiology CRO is at the forefront of this effort, leveraging technology and therapeutic expertise to support cardiology clinical trials across various indications. Our Clinical Operations (ClinOps) experts offer a comprehensive suite of clinical research services, including advanced clinical trial management and end-to-end integration through our innovative technology platform, TrialOS.

TrialOS seamlessly connects eSource, EDC, and ePRO on a single platform, enhancing efficiency and data quality. By partnering with Vial Cardiology CRO, sponsors can conduct clinical trials for heart diseases faster, more efficiently, and at a lower cost.

Want to learn more about how Vial is pioneering CVD prevention and treatment through clinical research? Connect with a Vial team member today!