New Acute, Chronic HF Guidelines Debut at ESC Heart Failure 2016

May 17, 2016

FLORENCE, ITALY – Unashamedly themed "Heart Failure: State of the Art" in the ancient home to the creations of Botticelli, Michelangelo, and Donatello, the European Cardiology Society (ESC) Heart Failure 2016 Congress will introduce new ESC guidelines for the diagnosis and treatment of acute and chronic heart failure as a kind of centerpiece display.

Around it will be 3 days of late-breaking clinical trials and >2000 abstract-based presentations of new research throughout the 4-day congress, held in conjunction with the 3rd World Congress on Acute Heart Failure.

The venue: the Firenze Fiera exhibition center inside the Fortress of Saint John the Baptist, the city's largest and probably most austere antiquity usually called the Fortezza da Basso, built by the Medicis in the 16th century.

New Guidelines on a Pedestal

The meeting's plan to usher in the new guidelines calls for a 90-minute overview session the morning of Saturday, May 21, headed by members of the panel that developed them. That's followed by a series of focused looks throughout the meeting at different facets of the document.

They include a presentations covering the guidelines' treatment of acute heart failure that Saturday afternoon; one Sunday morning on managing comorbidities; a Monday morning look at guidances for arrhythmias and devices; and the capper Tuesday morning covering chronic heart failure.

Sunday will also feature a session dedicated to international perspectives on the guidelines from experts representing the the Heart Failure Society of America and the Japanese Heart Failure Society, in a 90-minute session jointly sponsored by the two organizations.

Late-Breakers in the Gallery

Another cornerstone of the congress: 3 days of late-breaking trials on new and emerging therapies, the first session on pharmacologic options in acute heart failure, day 2 looking at drug and device approaches to chronic heart failure, and the third day a hodgepodge of modalities including drug and device therapies, strategies for prevention, and a transcatheter procedure.

The Saturday late-breaking session is slated to begin with the Bi Treatment With Hydralazine/Nitrates versus Placebo in Africans Admitted With Acute Heart Failure (B-AHEF) trial, a randomized, placebo-controlled test of the diuretic-vasodilator combination in addition to standard care. With a projected enrollment of 500 patients, the trial, based in Cape Town, South Africa, is looking at the effect of 24 weeks of treatment on time to death or heart-failure readmission.

The same session includes the Long-Term Intermittent Administration of Levosimendan in Patients With Advanced Heart Failure (LAICA) trial, which tests a positive inotropic agent given on a outpatient basis as a 24-hour infusion once a month for a year, on top of optimal standard drug therapy. The randomized trial had a projected enrollment of 213 patients with NYHA class 3–4 heart failure despite optimal chronic medication and at least one HF hospitalization in the previous 6 months. The primary end point is admission for acute decompensation.

The Saturday lineup also includes the following presentations:

  • RELAX-REPEAT: A multicenter, prospective, randomized, double-blind study evaluating the safety and tolerability of repeat doses of serelaxin (Novartis) in patients with chronic heart failure.

  • Positive hemodynamic effects of CXL-1427 (Bristol-Myers Squibb), a novel nitroxyl prodrug in advanced heart-failure patients.

  • The BLAST-AHF) trial: A phase 2b dose-finding study of TRV027 (Treventis), β-arrestin-biased ligand of the angiotensin-receptor study in acute heart failure.

  • The clinical value of neutrophil gelatinase-associated lipocalin (NGAL) for acute kidney injury during hospitalization for acute heart failure.

The Sunday session of late-breaking trials in chronic heart failure includes a randomized look at an implantable pacemakerlike device with transvenous leads that controls breathing muscles during sleep by phrenic-nerve stimulation. In a previous pilot study, HF patients with mixed central and obstructive sleep apnea who used the device showed significantly reduced prevalence of apnea episodes, driven by less central apneas.

The remedē System Pivotal Trial that will be presented here randomized about 170 patients with documented central sleep apnea to be implanted with the Respicardia device, either with the device turned on starting 1 month later or turned off for 6 months, all on top of standard medical therapy.

Then, a phase 2b study of the oral soluble guanylate-cyclase stimulator vericiguat (Bayer/Merck) will be examined in a presentation of the Safety and Efficacy Study of Four Dose Regimens of BAY1021189 in Patients With Heart Failure and Preserved Ejection Fraction Suffering From Worsening Chronic Heart Failure (SOCRATES-PRESERVED).

The trial is a companion to the previously reported SOCRATES-REDUCED that missed its natriuretic-peptide-based primary end point across a range of dosages but showed promise at the highest administered dose. SOCRATES-PRESERVED assigned 477 patients with recent exacerbation of preserved-ejection-fraction HF to receive vericiguat at four dosage levels or placebo, once daily for 5 weeks.

Other Sunday late-breaking trials are listed as:

  • Cardiovascular improvements with minute ventilation-targeted adaptive servoventilation (MV-ASV) therapy in heart failure.

  • Effect of liraglutide (Victoza, Novo Nordisk), a glucagonlike peptide-1 analogue, on left ventricular function in chronic heart-failure patients with and without diabetes.

  • Impact of unidirectional atrial shunting on heart failure-hospitalization: Results from the first-in-human experience.

The Monday late-breaking session will include the diabetes-subgroup analysis from the efficacy and safety of Aliskiren and Aliskiren/Enalapril Combination on Morbi-mortality in Patients With Chronic Heart Failure (ATMOSPHERE) trial, in which, overall, the addition of the renin inhibitor aliskiren (Tekturna, Novartis) to standard therapy with the ACE inhibitor enalapril failed to improve outcomes and was associated with an increased risk of hypotension and creatinine- and potassium-level elevation.

The analysis is noteworthy because after the trial was well under way, regulators in Europe forced the trial to stop giving aliskiren to patients with diabetes out of concern that it would reprise signals of harm observed among diabetics who took the drug in the ALTITUDE and ASTRONAUT trials. That, despite a run-in period in ATMOSPHERE designed to exclude susceptible patients. Nearly 1300 diabetic patients in the trial had already been treated with aliskiren for 2 years at the time regulators stepped in.

The Monday late-breaking session also includes:

  • Influenza vaccination and risk of hospitalization in patients with heart failure: A report from the UK primary- and secondary-care records.

  • Effect of cardiac resynchronization in patients with diabetes enrolled in EchoCRT.

  • Exercise training for chronic heart failure: An individual participant data meta-analysis.

  • Clinical benefits of LV volume reduction in ischemic cardiomyopathy heart-failure patients using a transcatheter technique.

There will be a daylong series of programs on Saturday, including the first late-breaking trials session, dedicated to the 3rd World Congress on Acute Heart Failure, and also a track for the allied meeting throughout Heart Failure 2016 within the main program.

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