Down the road from challenges in acute heart failure trials

Maaten, Jozine M. ter; Damman, Kevin

doi:10.1002/ejhf.1571

Cited by 6 publications

(8 citation statements)

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“…Given the mode of action of loop diuretics, natriuresis might not only be a sensitive, objective, accurate and quantifiable marker of response, but also the most reliable marker to assess response. 22 To date, multiple studies have demonstrated that impaired natriuretic response to loop diuretic treatment is associated with markers of persistent congestion, and with higher rates of HF rehospitalization and mortality. 6 , 8 , 9 , 10 Additionally, even early assessment of natriuresis in a spot urine sample 1 to 2 h after initiation of intravenous loop diuretic treatment has been shown to be an accurate marker of longer term (6 h) natriuretic response.…”

Section: Discussionmentioning

confidence: 99%

“…However, all of these are, to a certain extent, unreliable in daily clinical practice. Given the mode of action of loop diuretics, natriuresis might not only be a sensitive, objective, accurate and quantifiable marker of response, but also the most reliable marker to assess response 22 . To date, multiple studies have demonstrated that impaired natriuretic response to loop diuretic treatment is associated with markers of persistent congestion, and with higher rates of HF rehospitalization and mortality 6,8–10 .…”

Section: Discussionmentioning

confidence: 99%

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Natriuresis‐guided therapy in acute heart failure: rationale and design of the Pragmatic Urinary Sodium‐based treatment algoritHm in Acute Heart Failure (PUSH‐AHF) trial

Maaten

Beldhuis

Meer

et al. 2022

European J of Heart Fail

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Aims Insufficient diuretic response frequently occurs in patients admitted for acute heart failure (HF) and is associated with worse clinical outcomes. Recent studies have shown that measuring natriuresis early after hospital admission could reliably identify patients with a poor diuretic response during hospitalization who might require enhanced diuretic treatment. This study will test the hypothesis that natriuresis‐guided therapy in patients with acute HF improves natriuresis and clinical outcomes. Methods The Pragmatic Urinary Sodium‐based treatment algoritHm in Acute Heart Failure (PUSH‐AHF) is a pragmatic, single‐centre, randomized, controlled, open‐label study, aiming to recruit 310 acute HF patients requiring treatment with intravenous loop diuretics. Patients will be randomized to natriuresis‐guided therapy or standard of care. Natriuresis will be determined at set time points after initiation of intravenous loop diuretics, and treatment will be adjusted based on the urinary sodium levels in the natriuresis‐guided group using a pre‐specified stepwise approach of increasing doses of loop diuretics and the initiation of combination diuretic therapy. The co‐primary endpoint is 24‐h urinary sodium excretion after start of loop diuretic therapy and a combined endpoint of all‐cause mortality or first HF rehospitalization at 6 months. Secondary endpoints include 48‐ and 72‐h sodium excretion, length of hospital stay, and percentage change in N‐terminal pro brain natriuretic peptide at 48 and 72 h. Conclusion The PUSH‐AHF study will investigate whether natriuresis‐guided therapy, using a pre‐specified stepwise diuretic treatment approach, improves natriuresis and clinical outcomes in patients with acute HF.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Natriuresis‐guided therapy in acute heart failure: rationale and design of the Pragmatic Urinary Sodium‐based treatment algoritHm in Acute Heart Failure (PUSH‐AHF) trial

Maaten

Beldhuis

Meer

et al. 2022

European J of Heart Fail

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“…1,2 A heterogeneity of population is widely considered to be the most important reason for neutral findings of these trials. [3][4][5] Therefore, accurate profiling of patients admitted with AHF generates considerable interest in terms of designing clinical trials in the clinical settings of AHF. [6][7][8][9][10] Current European Society of Cardiology (ESC) Guidelines for diagnosis and treatment of acute and chronic heart failure (HF) recommend to classify patients with AHF according to clinical profiles, based on the presence or absence of congestion ('wet' vs. 'dry') and peripheral hypoperfusion ('cold' vs. 'warm') during bedside physical examination.…”

Section: Introductionmentioning

confidence: 99%

“…The last decades have witnessed recurrent disappointments of clinical trials in introducing novel treatment strategies, all of which have not improved the outcomes of patients with acute heart failure (AHF) 1,2 . A heterogeneity of population is widely considered to be the most important reason for neutral findings of these trials 3–5 . Therefore, accurate profiling of patients admitted with AHF generates considerable interest in terms of designing clinical trials in the clinical settings of AHF 6–10 …”

Section: Introductionmentioning

confidence: 99%

Distinct clinical phenotypes of congestion in acute heart failure: characteristics, treatment response, and outcomes

et al. 2020

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Aims Patients with acute heart failure (AHF) are included into clinical trials regardless of differences in baseline clinical characteristics. The aim of this study was to assess patients with AHF according to the presence of central and/or peripheral congestion at hospital admission and evaluate treatment response and outcomes in studied phenotypes. Methods and results We investigated retrospectively 352 patients (mean age: 68 ± 13 years, 77% men) hospitalized due to AHF with the signs of congestion on admission. Patients were divided according to the type of signs of congestion into three groups: A, isolated pulmonary congestion (n = 52, 15%); B, isolated peripheral congestion (n = 31, 9%); and C, signs of mixed (peripheral and central) congestion (n = 269, 76%). Patients from Group A had lower concentration of urea, bilirubin, and gamma-glutamyl transferase whereas higher level of haematocrit, albumin, and leukocytes on admission. The highest baseline N-terminal pro-B-type natriuretic peptide level (median: 4113 vs. 3634 vs. 6093 pg/mL) and percentage of patients with chronic heart failure (56 vs. 58 vs. 74%; A vs. B. vs. C, respectively, all P < 0.01) were observed in Group C. There were no differences in terms of demographics, co-morbidities, left ventricular ejection fraction, and applied treatment between studied groups. Patients from Group A had the highest systolic blood pressure on admission (145 ± 37 vs. 122 ± 20 vs. 130 ± 29 mmHg) and the biggest decrease in systolic blood pressure [À22 (À45 to À4) vs. À2 (À13 to 2) vs. À10 (À25 to 0) mmHg] and heart rate [À16 (À35 to À1.5) vs. À1 (À10 to 5) vs. À7 (À20 to 0) b.p.m.] with the lowest weight change [À1.0 (À1.0 to 0) vs. À2.9 (À3.8 to À0.9) vs. À2.0 (À3.0 to À1.0) kg; all P < 0.01] after 48 h of hospitalization. There were differences in short-term and long-term outcomes with favourable results in Group A. Group A experienced less frequent in-hospital heart failure worsening during the first 48 h (4 vs. 23 vs. 7%), had shorter length of hospital stay [6 (5-8) vs. 7 (5-11) vs. 7 (6-11) days], and had lower 1 year all-cause mortality (12 vs. 28 vs. 29%; all P < 0.05). Presence of peripheral congestion on admission was independent predictor for all-cause mortality within 1 year [hazard ratio (95% confidence interval): 2.68 (1.06-6.79); P = 0.04]. Conclusions Patterns of congestion in AHF are associated with differences in clinical characteristics, treatment response, and outcomes. It needs to be considered once planning clinical trials in AHF.

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“…История применения петлевых диуретиков началась в 60-х гг. XX века, и с тех пор данная группа препаратов остается краеугольным камнем лечения перегрузки объемом при сердечной недостаточности (СН) [4]. Европейским обществом кардиологов (ЕОК) был предложен алгоритм, определяющий начальную дозу петлевого диуретика [5], однако общепринятая схема дозирования до сих пор отсутствует [6].…”

Section: Introductionunclassified

Natriuresis as a Way to Assess the Effectiveness of Diuretic Therapy for Acute Decompensated Heart Failure: Data from a Pilot Study

Charaya

Shchekochikhin

Tarasenko

et al. 2023

Racionalʹnaâ farmakoterapiâ v kardiologii

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Aim. To analyze the clinical significance of the sodium level in a single urine test obtained 2 hours after the first dose of a loop diuretic was administered in patients with acute decompensation of chronic heart failure (ADHF).Material and methods. An observational study was conducted on the basis of a rapid-care hospital. The concentration of sodium in urine analysis obtained 2 hours after intravenous administration of the first dose of loop diuretic and natriuresis for the first day of hospitalization were evaluated. The development of resistance to diuretics was taken as the primary endpoint (the need to increase the daily dose of furosemide by more than 2 times compared to the initial one or the addition of another class of diuretic drugs).Results. 25 patients with ADHF were included. The average age of patients was 69.0±14.8 years, 16 (64%) of them were men. The average left ventricular ejection fraction was 49.0±13.5%. The level of the N‐terminal fragment of the brain natriuretic peptide (NT-proBNP) was 3416 (2128; 5781) pg/ml. The average sodium concentration in the urine analysis obtained 2 hours after the start of treatment was 100.6±41.0 mmol / l. The concentration of sodium in urine for the first day was 102.2±39.0 mmol/l. 2 hours after the start of treatment, the sodium concentration in a single urine test was less than 50 mmol/l in 5 (20%) patients. Upon further observation, oligoanuria (defined as diuresis of less than 400 ml within 24 hours) developed in 2 of them. Oligoanuria was not detected among patients whose sodium concentration was more than 50 mmol/l. The need for escalation (any increase in the dose of a loop diuretic and/or the addition of another class of diuretic drugs) arose in 7 (28%) patients; at the same time, we diagnosed the development of resistance to diuretics in 5 (20%) of them. Resistance to diuretics was more common among patients with a sodium concentration in a single urine test obtained 2 hours after the start of furosemide administration, less than 50 mmol/l (p=0.037); when dividing the recruited patient population into subgroups with a sodium concentration in a single urine test ≥50 mmol/l and <50 mmol/l there was no significant difference in the need for any escalation of diuretic therapy [3 (60%) vs 4 (20%), p=0.07].Conclusion. Resistance to diuretics is more common among patients with a sodium concentration in a single urine test obtained 2 hours after the first dose of furosemide, less than 50 mmol / l. Evaluation of natriuresis allows to identify insufficient effectiveness of diuretic therapy already at the beginning of treatment.

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Down the road from challenges in acute heart failure trials

Cited by 6 publications

References 12 publications

Natriuresis‐guided therapy in acute heart failure: rationale and design of the Pragmatic Urinary Sodium‐based treatment algoritHm in Acute Heart Failure (PUSH‐AHF) trial

Natriuresis‐guided therapy in acute heart failure: rationale and design of the Pragmatic Urinary Sodium‐based treatment algoritHm in Acute Heart Failure (PUSH‐AHF) trial

Distinct clinical phenotypes of congestion in acute heart failure: characteristics, treatment response, and outcomes

Natriuresis as a Way to Assess the Effectiveness of Diuretic Therapy for Acute Decompensated Heart Failure: Data from a Pilot Study

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