Expanding treatment options for heart failure through clinical trials

When we hear the term heart failure, we may assume that the heart has stopped functioning altogether. However, it means the heart is no longer able to pump an adequate amount of blood to fulfill the body's need for oxygen and nutrients.

It's crucial for those experiencing heart failure to seek medical attention and receive proper care. And, with the help of clinical trials, there are many treatment options available to those with heart failure.

Understanding heart failure and its impact 

Heart failure (also called congestive heart failure), which affects more than 6 million Americans, can cause shortness of breath, weakness and fatigue. Walking up the stairs, performing chores around the house and engaging in activities that once seemed effortless can suddenly seem insurmountable. Chest pain — often accompanied by an irregular heartbeat — persistent coughing and swollen feet or ankles are also common symptoms of heart failure.

"Managing heart failure presents significant challenges, as it's a chronic condition without a definitive cure," says Christopher Droogan, DO, heart failure cardiologist at Main Line Health. "While medication and lifestyle adjustments like increased exercise and adopting a low-sodium diet can often effectively control symptoms, advanced cases may necessitate interventions such as specialized pacemakers or defibrillator implantation."

However, when conventional treatments fall short and patients continue to experience severe symptoms, exploring alternative options, such as participation in clinical trials, becomes crucial.

What to consider before joining a clinical trial 

Before enrolling in a clinical trial, it's vital to discuss all aspects with your health care provider. Understand the potential risks and benefits, how it might affect your daily life and what kind of commitment is required.

Gather as much information as possible about the trial's purpose, the treatments involved and any possible side effects. Remember, your safety and well-being are paramount. Make sure you feel comfortable and fully informed before making a decision.

Additionally, you should consider whether your insurance covers the associated costs. Consulting with a trusted individual or family member may also help you in deciding if you should participate.

The role of clinical trials in advancing heart failure treatment

Patients can access clinical trials through their cardiologist at Main Line Health, because of its connection to the Lankenau Institute for Medical Research (LIMR), the health system's research division.

"The convergence of clinical leadership and research holds tangible benefits for our patients, particularly those with heart failure," says Dr. Droogan. "Often, we can provide access to treatment alternatives through clinical trials that are not accessible elsewhere in the region."

Clinical trials for heart failure at Lankenau Heart Institute 

ALT-FLOW II is one example of a trial offered regionally only by Lankenau Heart Institute. It seeks to treat a common type of heart failure where the heart's left lower chamber (ventricle) can squeeze blood normally but is unable to relax and fill with blood properly, resulting in increased blood pressure in the left ventricle and atrium (upper chamber). The trial evaluates the safety and effectiveness of an experimental transcatheter shunt system designed to ease the pressure — and heart failure symptoms.

By partially relieving pressure in the left atrium, pressure in the lungs is also relieved, which in turn helps to alleviate shortness of breath for patients.

Another research trial, EMPOWER, is designed for patients who have reduced heart-pumping capacity and a condition called mitral valve regurgitation, in which the valve fails to close properly and blood flows backward into the top left chamber and lung vessels. For patients with these conditions, the heart becomes enlarged to try to compensate for the loss of pumping capacity and works less efficiently.

"By implanting a small device with a catheter that addresses the problem with the valve's structure, we seek to tighten the mitral valve so it leaks less ," says Dr. Droogan, who is principal investigator for the trial. "We hope that this reduction in heart size will enhance the mechanical pumping action."

Finally, the CADENCE trial investigates the efficacy of sotatercept, a medication used for treating chronic pulmonary congestion-associated pulmonary hypertension (CPC-PH) stemming from heart failure with preserved ejection fraction (HFpEF). This study aims to address the significant unmet need for effective therapies in this patient population. By targeting the dysregulated TGF-β signaling pathway implicated in HFpEF, sotatercept offers a promising avenue for improving hemodynamics and functional outcomes in patients with CPC-PH.

"We are very excited be a part of this international trial as it offers a potential option for a sub-group of pulmonary hypertension patients in which there are currently no FDA approved treatments for yet," says Steven Domsky, MD, principal investigator and heart failure cardiologist at Main Line Health.

We currently oversee a portfolio of more than 50 clinical trials in cardiology that seek to advance treatment options. Its trials address coronary artery disease, heart rhythm disorders, structural heart and valve disorders and other cardiac conditions.

Participating in a clinical trial opens the door to cutting-edge treatments not yet available to the general public. While every trial has its own set of criteria and outcomes, the possibility of accessing promising new treatments provides hope and an active role in one's health care journey.

Next steps:

Schedule an appointment with a heart failure cardiologist
Learn about heart failure clinical trials
Learn more about heart and vascular care at Main Line Health