03:49pm Sunday 20 August 2017

RELAX-AHF shows first positive findings in HFpEF patients, VIVIDD reveals vildagliptin non-inferior to placebo

Sunday’s late breaking trial session included the following abstracts: Link to session on the Scientific Programme Online.

  • Serelaxin in acute heart failure patients with preserved left ventricular ejection fraction: from the RELAX-AHF trial. G. S. Filippatos  
  • Effectiveness and safety of continuous infusion compared to intermittent boluses of intravenous furosemide in acutely decompensated heart failure: a randomised clinical trial.  P. Llorens Soriano
  • Prospective study of the BioVentrix PliCath HF system for the treatment of ischemic cardiomyopathy (CONFIGURE HF), Phase I. J. R. Teerlink
  • Galectin-3 Reflects Functional Capacity and Clinical Outcome in Heart Failure with Preserved Ejection Fraction.  F. Edelmann
  • The Vildagliptin in Ventricular Dysfunction Diabetes trial (VIVIDD).  J. J. V. McMurray
  • A randomised, double-blind, placebo-controlled, multicentric study to assess hemodynamic effects of serelaxin in acute heart failure patients. P. Ponikowski
 
The Heart Failure Congress is the main annual meeting of the Heart Failure Association of the European Society of Cardiology and is being held 25-28 May in Lisbon, Portugal (2).

Many patients with acute heart failure (AHF) have preserved ejection fraction but there is a lack of evidence based therapies for this population. In a sub-group analysis, investigators of the Relaxin in Acute Heart Failure (RELAX-AHF) trial addressed the question of whether serelaxin was equally effective in AHF patients with HFpEF and HFrEF.
 
RELAX-AHF was a double blinded, randomised, placebo controlled trial in which 1161 AHF patients from 96 sites were randomised to 48 hour infusion of serelaxin or placebo within 16 hours of presentation. The primary efficacy endpoint was the effect on dyspnea in the short term (6, 12 and 24 hours) and at 5 days. Secondary efficacy endpoints were cardiovascular death or rehospitalisation for heart or renal failure, and days alive and out of hospital through day 60. All-cause death and cardiovascular death through day 180 were also evaluated.
 
Serelaxin induced similar dyspnea relief in HFpEF and HFrEF patients at day 5 but was more effective in the HFpEF group in the first 24 hours. There were no differences between HFpEF and HFrEF patients in the effect of serelaxin on the secondary endpoints. Serelaxin had similar benefits on mortality in patients with HFpEF and HFrEF.
 

Presenter Professor Gerasimos Filippatos (Greece) said: “RELAX-AHF is the first trial to give positive findings in patients with acute heart failure and preserved ejection fraction, a large population with unmet treatment needs. Seralaxin is at least as effective in AHF patients with HFpEF for relieving dyspnea during the first 24 hours and had a similar effect on rehospitalisation and survival in HFrEF and HFpEF patients.”

 
The Vildagliptin in Ventricular Dysfunction Diabetes (VIVIDD) trial investigated the effects of the DPP4 inhibitor vildagliptin in patients with type 2 diabetes and HFrEF (left ventricular ejection fraction [LVEF] <40%). It is the first study to test this class of anti-diabetes drugs in patients with heart failure.

Presenter Professor John McMurray (UK) said: “Diabetes and heart failure is a common dual problem and these patients have a particularly bad outlook. But, remarkably, patients with heart failure are excluded from most trials testing diabetes drugs. At the moment it’s not at all clear how clinicians should choose between the various anti-diabetes drugs when confronted with a heart failure patient.”

The primary objective of this randomised, double-blind, placebo controlled trial was to demonstrate that vildagliptin was non-inferior to placebo with respect to change in echocardiographic LVEF from baseline to 52 weeks. For the trial, 254 patients from 15 countries were randomised to 52 weeks treatment with placebo or vildagliptin 50mg bid.

The effect of vildagliptin on LVEF did not differ from placebo, confirming non-inferiority. But, unexpectedly, vildagliptin increased the size of the left ventricle with no decline in the contraction and emptying of the left ventricle and no change in B-type natriuretic peptide (BNP).

Professor McMurray said: “Normally an increase in the size of the left ventricle is associated with a decline in systolic function but we saw no change in ejection fraction and a fall rather than increase in BNP. We speculate that the surprising findings of VIVIDD indicate that this anti-diabetes drug may have improved the distensibility and compliance of the left ventricle.”

He concluded: “We don’t have enough studies investigating the effects of anti-diabetes drugs in patients with both diabetes and heart failure. The two diseases clearly interact in many ways and unless a drug is studied in these very vulnerable patients we will never know what effect it has.”

END

 

Authors: ESC Press Office
press@escardio.org
Office: +334 92 94 77 56
On Site contact: +3 51 916 30 63 49

Notes to editor
About the European Society of Cardiology (ESC)
The European Society of Cardiology (ESC) represents more than 80,000 cardiology professionals across Europe and the Mediterranean. Its mission is to reduce the burden of cardiovascular disease in Europe.

About the Heart Failure Association (HFA)
The Heart Failure Association (HFA) is a registered branch of the ESC. Its aim is to improve quality of life and longevity, through better prevention, diagnosis and treatment of heart failure, including the establishment of networks for its management, education and research.

For practical information about heart failure aimed at patients, families and caregivers, visit the HFA’s Heart Failure Matters website.

About press registration
On-site registration opens 25 May 2013 in Lisbon supported by presentation of a press card or letter of assignment with proof of 3 published articles together with the filled in and signed embargo form 2013.

Scientific Programme Online

References

  1. Sunday’s late breaking trial session included the following abstracts: Link to session on the Scientific Programme Online
    • Serelaxin in acute heart failure patients with preserved left ventricular ejection fraction: from the RELAX-AHF trial. G. S. Filippatos  
    • Effectiveness and safety of continuous infusion compared to intermittent boluses of intravenous furosemide in acutely decompensated heart failure: a randomised clinical trial.  P. Llorens Soriano
    • Prospective study of the BioVentrix PliCath HF system for the treatment of ischemic cardiomyopathy (CONFIGURE HF), Phase I. J. R. Teerlink
    • Galectin-3 Reflects Functional Capacity and Clinical Outcome in Heart Failure with Preserved Ejection Fraction.  F. Edelmann
    • The Vildagliptin in Ventricular Dysfunction Diabetes trial (VIVIDD).  J. J. V. McMurray
    • A randomised, double-blind, placebo-controlled, multicentric study to assess hemodynamic effects of serelaxin in acute heart failure patients. P. Ponikowski
  2. Heart Failure 2013

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