The impact of early standard therapy on dyspnoea in patients with acute heart failure: the URGENT-dyspnoea study

Mebazaa, Alexandre; Pang, Peter S.; Tavares, Miguel; Collins, Sean P.; Storrow, Alan B.; Laribi, Sai͏̈d; André, S.; Courtney, D. Mark; Hasa, J; Špinar, Jindřich; Masip, Josep; Peacock, W. Frank; Sliwa, Karen; Gayat, Étienne; Filippatos, Gerasimos; Cleland, John G.F.; Gheorghiade, Mihai

doi:10.1093/eurheartj/ehp458

Cited by 167 publications

(114 citation statements)

References 20 publications

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“…Other studies that focused on dyspnoea relief suggested that earlier initiation of therapy provides greater symptom relief 27. However, in one study, only two‐thirds of the enrolled patients with a suspected diagnosis of AHF within 1 h of presentation were confirmed to have AHF at 6 h after presentation, suggesting that too rapid enrolment might result in patients without AHF being included in the trial 28. In both Pre‐RELAX‐AHF21 and RELAX‐AHF19 patients were randomized within 16 h of presentation at a median of 8–9 h; this time frame is the goal for RELAX‐AHF‐2 as well.…”

Section: Discussionmentioning

confidence: 98%

Serelaxin in addition to standard therapy in acute heart failure: rationale and design of the RELAX‐AHF‐2 study

Teerlink

Voors

Ponikowski

et al. 2017

European J of Heart Fail

109

103

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Patients admitted for acute heart failure (AHF) experience high rates of in‐hospital and post‐discharge morbidity and mortality despite current therapies. Serelaxin is recombinant human relaxin‐2, a hormone with vasodilatory and end‐organ protective effects believed to play a central role in the cardiovascular and renal adaptations of human pregnancy. In the phase 3 RELAX‐AHF trial, serelaxin met its primary endpoint of improving dyspnoea through day 5 in patients admitted for AHF. Compared to placebo, serelaxin also reduced worsening heart failure (WHF) by 47% through day 5 and both all‐cause and cardiovascular mortality by 37% through day 180. RELAX‐AHF‐2 ( ClinicalTrials.gov NCT01870778) is designed to confirm serelaxin's effect on these clinical outcomes. RELAX‐AHF‐2 is a multicentre, randomized, double‐blind, placebo‐controlled, event‐driven, phase 3 trial enrolling ∼6800 patients hospitalized for AHF with dyspnoea, congestion on chest radiograph, increased natriuretic peptide levels, mild‐to‐moderate renal insufficiency, and systolic blood pressure ≥125 mmHg. Patients are randomized within 16 h of presentation to 48 h intravenous infusions of serelaxin (30 µg/kg/day) or placebo, both in addition to standard of care treatments. The primary objectives are to demonstrate that serelaxin is superior to placebo in reducing: (i) 180 day cardiovascular death, and (ii) occurrence of WHF through day 5. Key secondary endpoints include 180 day all‐cause mortality, composite of 180 day combined cardiovascular mortality or heart failure/renal failure rehospitalization, and in‐hospital length of stay during index AHF. The results from RELAX‐AHF‐2 will provide data on the potential beneficial effect of serelaxin on cardiovascular mortality and WHF in selected patients with AHF.

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Section: Discussionmentioning

confidence: 98%

Serelaxin in addition to standard therapy in acute heart failure: rationale and design of the RELAX‐AHF‐2 study

Teerlink

Voors

Ponikowski

et al. 2017

European J of Heart Fail

109

103

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“…9,10,12,13 These studies demonstrate that contemporary ADHF therapy is suboptimal not only with respect to outcomes, 21 but also with respect to symptom relief. 22 Therefore, it is important to understand the reasons for the failure to improve dyspnea.…”

Section: Discussionmentioning

confidence: 99%

Hemodynamic Determinants of Dyspnea Improvement in Acute Decompensated Heart Failure

Solomonica

Burger

Aronson

2013

Circ: Heart Failure

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Background— Dyspnea relief constitutes a major treatment goal and a key measure of treatment efficacy in decompensated heart failure. However, there are no data with regard to the relationship between hemodynamic measurements during treatment and dyspnea improvement. Methods and Results— We studied 233 patients assigned to right heart catheterization in the Vasodilation in the Management of Acute Congestive Heart Failure trial. Dyspnea (assessed using a 7-point Likert scale) and hemodynamic parameters were measured simultaneously at 15 and 30 minutes and 1, 2, 3, 6, and 24 hours. Dyspnea relief was defined as moderate or marked improvement. There was a time-dependent association between the reductions in pulmonary capillary wedge pressure (PCWP; 25.4, 24.6, 24.0, 23.5, 23.4, 21.5, and 19.9 mm Hg) and the percentage of patients achieving dyspnea relief (17.7%, 24.6%, 32.2%, 36.2%, 37.8%, 47.4%, and 66.1%, in the respective time points). Multivariable logistic generalized estimating equations modeling demonstrated that reductions of both PCWP and mean pulmonary artery pressure were independently associated with dyspnea relief. Compared with the highest PCWP quartile, the adjusted odds ratios for dyspnea relief were 0.92 (95% confidence interval [CI], 0.67–1.29), 1.07 (95% CI, 0.75–1.55), and 1.80 (95% CI, 1.22–2.65) in the third, second, and first PCWP quartiles, respectively ( P trend =0.003). Compared with the highest mean pulmonary artery pressure quartile, the adjusted odds ratios for dyspnea relief were 2.0 (95% CI, 1.41–2.82), 2.23 (95% CI, 1.52–3.27), and 2.98 (95% CI, 1.91–4.66) in the third, second, and first mean pulmonary artery pressure quartiles, respectively ( P trend <0.0001). Conclusions— A clinically significant improvement in dyspnea is associated with a reduction in both PCWP and mean pulmonary artery pressure.

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“…There has been enormous growth in knowledge about the neurophysiology of dyspnea. In addition, there has been growing interest in the potential use of dyspnea as a patient-reported outcome in clinical trials of pharmacologic and nonpharmacologic interventions in patients with cardiopulmonary disease (17,18).…”

Section: Introductionmentioning

confidence: 99%

An Official American Thoracic Society Statement: Update on the Mechanisms, Assessment, and Management of Dyspnea

Parshall¹,

Schwartzstein²,

Adams³

et al. 2012

Am J Respir Crit Care Med

1,500

1,328

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The impact of early standard therapy on dyspnoea in patients with acute heart failure: the URGENT-dyspnoea study

Cited by 167 publications

References 20 publications

Serelaxin in addition to standard therapy in acute heart failure: rationale and design of the RELAX‐AHF‐2 study

Serelaxin in addition to standard therapy in acute heart failure: rationale and design of the RELAX‐AHF‐2 study

Hemodynamic Determinants of Dyspnea Improvement in Acute Decompensated Heart Failure

An Official American Thoracic Society Statement: Update on the Mechanisms, Assessment, and Management of Dyspnea

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