This article will define what heart failure is and describe the current clinical treatment guidelines and how contract research organizations (CROs) can help manage clinical trials for developing new clinical treatments for heart failure.
What is Heart Failure?
Heart failure is a common cardiovascular syndrome characterized by the loss of the heart’s ability to pump enough blood to meet the body’s demand for oxygen effectively. It is estimated to affect 1-14% of the US population.
Over the past few decades, the increase in the prevalence of heart failure can be attributed partly to improved survival rates of other diseases and partly to the rise in lifestyle diseases that lead to heart failure. As heart failure usually presents in older adults, the incidence is expected to rise with the aging population in the United States.
What causes heart failure?
Heart failure is a secondary disease, which means it is caused by the consequences of other disease processes that affect how the heart functions.
There is a multitude of conditions that can result in heart failure, including:
- Ischemic heart disease
- Hypertension
- Valvular heart disease
- Genetic cardiomyopathies
- Infiltrative heart diseases
- Myocarditis
- Cardiac arrhythmia
- Cardiotoxic side effects from medications
- Substance abuse
In addition to underlying cardiovascular diseases, common risk factors for heart failure include:
- Diabetes
- Obesity
- Smoking
- Older age
- Sedentary lifestyle
- Family history of multigenerational heart failure
Types of heart failure
As many conditions lead to heart failure, the nature of the syndrome can be categorized based on differences in causes and the progression of the disease.
Left-sided heart failure is caused by dysfunction of the left ventricle, the heart chamber responsible for pumping the oxygenated blood from the lungs to the rest of the body. It can be further divided into subtypes determined by the disease’s effect on the ejection fraction (amount of blood pumped out by the left ventricle during each heartbeat).
- Heart failure with reduced ejection fraction (HFrEF) originates from a weakened left ventricle that cannot pump blood with the required pressure. HFrEF is also called systolic heart failure, as it arises from a problem during the cardiac cycle phase when the left ventricle’s muscle contracts (systole). HFrEF is usually caused by damage to the left ventricle, as seen in coronary artery disease (CAD), in which there is reduced blood supply to the heart muscle itself because of blockages in its arteries.
- Heart failure with preserved ejection fraction (HFpEF) results from the thickening of the left ventricle, making it too stiff to fill with the amount of blood required to be pumped to the rest of the body. This can be caused by hypertrophy of the left ventricle in response to other diseases, such as hypertension. HFpEF is also known as diastolic heart failure, as it is a disorder of the filling phase of the cardiac cycle (diastole).
Right-sided heart failure usually develops over time due to left-sided heart failure as the blood backs up to the lung, subsequently causing increased pressures in the right ventricle, damaging the tissue.
Causes of right ventricular failure can also include:
- Direct damage to the right ventricle from myocardial infarction, infiltrative cardiac disease, or cardiomyopathy
- An acute increase in pressure from diseases of the lung, such as pulmonary embolism or acute respiratory distress syndrome (ARDS)
- Chronic pressure overload from pulmonary hypertension, COPD, or pulmonary stenosis.
- Volume overload caused by abnormalities in the tricuspid or pulmonary valves on the right side of the heart or congenital heart diseases with a shunt, such as atrial septal defect.
Symptoms of heart failure
Typical symptoms experienced by patients with heart failure include:
- Shortness of breath, especially during exertion and while lying down
- Feeling tired easily
- Weakness
- Dizziness
- Rapid heart rate
- Swelling of the feet, ankles, legs, and abdomen
Diagnosing heart failure
Heart failure diagnosis is made through a thorough evaluation by a cardiologist, as any underlying causes and risk factors must be assessed to create an individualized treatment plan.
The initial evaluation includes understanding the patient’s current symptoms, medical and family history, and conducting a physical examination to look for clinical signs of heart failure.
Further testing to establish a baseline and find potential causes is needed in patients showing signs of heart failure. Testing will look different for each patient based on their history, exam, and severity of symptoms.
Diagnostic testing for heart failure
- Electrocardiogram (ECG) to evaluate any abnormalities in the heart rate, rhythm, and overall function.
- Blood tests to look for abnormalities in electrolytes, liver function, kidney function, blood cells, lipid profile, thyroid stimulating hormone, and for biomarkers of specific diseases, such as BNP and D-dimers.
- Genetic testing may be required ****in cases where genetic cardiomyopathy is suspected.
- Cardiac imaging, which may include:
- Chest X-Rays
- Echocardiography
- Cardiac MRI
- Cardiac CT
- Nuclear Imaging
- Cardiac Catheterization
Treatment of Heart Failure
The treatment of heart failure is complex and varies by the disease’s cause, subtype, and severity.
- Lifestyle changes to modify risk factors can help prevent the onset and worsening of heart failure and are recommended in all patients with heart failure or with an increased risk of the disease.
Some of the recommendations including:
- Daily weighing to assess for excess fluid retention.
- Limiting salt and water intake.
- Weight loss for those who are obese.
- Maintaining a healthy diet.
- Quitting cigarette smoking.
- Decreasing alcohol intake.
- Getting regular exercise.
- Medication management for heart failure should be tailored to the patient to meet the following goals:
- Address the risk factors and underlying causes of the disease, such as controlling high blood pressure or glucose levels in those with diabetes.
- Treat heart failure symptoms, such as edema and shortness of breath from fluid overload.
- Slow down the disease process and prolong lifespan.
Currently, there are clinical trials being conducted to expand on and develop clinical treatment for heart failure.
Clinical Treatment Guidelines
The current treatment guidelines based on cardiology clinical trials to treat heart failure are different for those with a reduced ejection fraction and those with a preserved ejection fraction.
Medication regimens used for heart failure with reduced ejection fraction may include:
- Diuretics, such as lisinopril, to remove excess fluid.
- Renin-Angiotensin system inhibitors, such as ACE inhibitors, ARBs, or ARNis to reduce blood pressure and improve heart function.
- Beta-blockers to reduce heart rate and blood pressure.
- SGLT2 inhibitors, a class of diabetic medications that have been shown to reduce hospitalizations and improve heart failure prognoses.
- Mineralocorticoid receptor antagonists that have shown to reduced mortality, hospitalizations, and sudden cardiac death.
- Hydralazine and nitrate combination to dilate blood vessels.
Medication regimens for heart failure with preserved ejection fraction may include:
- Diuretics, such as lisinopril, to remove excess fluid.
- SGLT2 inhibitors to reduce hospitalizations and improve prognosis.
- Mineralocorticoid receptor antagonists that have shown to reduced mortality, hospitalizations, and sudden cardiac death.
- Renin-Angiotensin system inhibitors, such as ARBs and ARNIs.
While clinical research in cardiology has led to new drugs and devices and the creation of treatment guidelines frequently updated with emerging data, the incidence, and prevalence of heart failure is expected to increase in the coming years. Early intervention and further research for preventative and therapeutic options are needed to treat the underlying causes and halt their progression to heart failure, and decrease hospitalizations and mortality rates in those who already have heart failure.
What is a CRO?
A CRO is a contract research organization, also known as a clinical research organization. CRO services include helping biotech, Pharmaceutical, and medical device companies manage clinical trials. CROs take on the core responsibilities of executing a clinical trial, interacting and managing a site, and providing support and technology to successfully produce trial results. CROs play a monumental role in running successful clinical trials for heart failure and other indications in cardiology.
Interested in impacting the lives of your patients with cardiovascular diseases? Partner with Vial Cardiology CRO to help run your clinical trials with increased efficiency at a lower cost. We are a tech-enabled CRO that supports cardiology clinical trials across multiple indications. Our ClinOps experts will provide you with a fully integrated suite of CRO services, including next-generation clinical trial management and end-to-end streamlining with Vial Technology Platform, which connects eSource, EDC, and ePRO on one system.
