ALLAY-HFrEF

Summary

Chronic heart failure (CHF) is a progressive condition that currently affects almost 7 million adults in the U.S., with an estimated increase to more than 8 million in 2030. Approximately half of these patients are considered to have a reduced ejection fraction (that is, LVEF of 40% or lower)—meaning that the heart isn't pumping out enough oxygen-rich blood for the body’s needs. In addition, despite receiving maximum recommended levels of medication-based treatments, many of these patients still experience significant, debilitating disease symptoms. The ALLAY-HFrEF study evaluates the safety and efficacy of a minimally invasive procedure designed for this particular patient population.

The system evaluated in ALLAY-HFrEF is intended to adjust the route blood follows through the heart. This procedure creates a permanent passageway between the left and right atria (the upper 2 chambers of the heart). In previous heart failure studies, allowing blood to flow from the left atrium to the right decreased the pressure in the left atrium and thereby reduced symptoms of heart failure.

Once participants have been cleared to join ALLAY-HFrEF, they'll be assigned randomly (50:50, like a coin toss) to undergo the study procedure (including creation of the opening between the 2 atria) or will experience all parts of the procedure EXCEPT for the opening. Neither the lead scientist nor the participant can choose which procedure they'll receive. Participants can anticipate being involved in ALLAY-HFrEF follow-up activities for approximately 36 months.

To be included in ALLAY-HFrEF, participants must be / have

• Adult 18 years of age or older
• Symptomatic heart failure with reduced ejection fraction (LVEF 40% or lower)
• Receiving optimal, maximally tolerated, stable guideline-directed medical therapy for heart failure for at least 2 months prior to the baseline study visit

To be included in ALLAY-HFrEF, participants must not be / have

• Advanced heart failure
• Clinically significant untreated disease or narrowing of the coronary (heart) vessels likely to require treatment within 1 year of the baseline study visit
• Stroke, transient ischemic attack, deep vein thrombosis, or thromboembolic episode (blood clot, blocked blood vessel, embolism) within 6 months of the baseline study visit
• History of prior cardiac procedure or event, including (but not limited to) coronary artery bypass, heart valve replacement or repair, and myocardial infarction (heart attack)
• Other medical conditions including (but not limited to) pregnancy, chronic pulmonary disease (such as requiring home oxygen use), severe obstructive sleep apnea, and significant kidney or liver disease

Keywords
Heart failure; Interatrial shunt; Intracardiac shunt