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Quality of life hope for HFpEF patients

Heart Failure 2016 Congress News

Burkert Pieske (Charite – Universitätsmedizin Berlin, Germany)

Late Breaking Trials II: Focus on chronic heart failure; 22 May, 08:30–10:00; Paris

Clinicians could be on the brink of having, for the first time, a treatment that improves quality of life in patients with heart failure and preserved ejection fraction (HFpEF).

That is the hope of study findings that will be presented this morning as part of the Late Breaking Trials II: Focus on chronic heart failure session by Burkert Pieske (Charite – Universitätsmedizin Berlin, Germany).

The results are from a pre-specified exploratory endpoint of SOCRATES-PRESERVED, a placebo-controlled dose-finding study of the oral soluble guanylate cyclase (sGC) stimulator vericiguat in HFpEF patients, which looked at the safety, tolerability, pharmacodynamic effects and pharmacokinetics of vericiguat 1.25 mg, 2.5 mg, 5 mg, and 10 mg once daily.

Here, the aim of this analysis is to examine the impact of vericiguat on patient-reported quality of life in 447 patients with a HFpEF. “This is a very important measure because, particularly in heart failure with preserved ejection fraction, quality of life is poor,” said Prof. Pieske, adding “at the moment we do not have any approved means to improve patient-reported outcomes and quality of life.”

Stimulation of sGC leads to an increase in cyclic guanosine monophosphate (GMP), which in turn mediates improved vasodilation, vascular function, diastolic function, and coupling of left ventricular ejection into the systemic circulation.

“In other words, a rationale for improved quality of life could be attributed to improved central hemodynamics with vericiguat, leading to improved clinical function,” said Prof. Pieske.

The primary endpoint of the study is change in log-transformed NT-ProBNP levels and left atrial volume at 12 weeks. The researchers also assessed the patients’ health status using the Kansas City Cardiomyopathy Questionnaire (the KCCQ), as well as the ED-5Q instrument. “The selection of appropriate endpoints in HFpEF phase II studies remains a matter of debate,” adds Prof. Pieske.

If, when the results are presented today, vericiguat is found to have significantly improved quality of life compared to placebo, Prof. Pieske said that this would be “a clinically relevant and important finding because, for the first time, this would indicate that there might be a new therapeutic approach to improved quality of life in these patients.”

View the session programme and access the resources on SP&P