The Role of intraABDOminal Pressure and Point Of Care UltraSound to Guide Decongestive Therapy in Heart Failure

Обзор

Systemic venous congestion is the primary therapeutic target of intravenous loop diuretics in patients admitted for acute heart failure (AHF). Despite their utility, a significant proportion of AHF patients are discharged with persistent clinical symptoms of congestion (residual congestion). Therefore, in recent years, there has been a growing focus on the use of tools (biomarkers, clinical ultrasound) that allow us to optimize diuretic treatment and thereby improve the prognosis of AHF patients. The objective is to analyze whether the strategy of guiding intravenous loop diuretic dosing based on intra-abdominal pressure(IAP) measurements and clinical ultrasound is superior to the conventional strategy employed in daily clinical practice. This study is a randomized, multicenter clinical trial involving consecutive patients admitted with a diagnosis of AHF in the Internal Medicine and Cardiology departments. Patients who meet the inclusion criteria, after signing informed consent, will be randomized into two groups: 1) Diuretic treatment guided by usual clinical practice and 2) Treatment guided by intra-abdominal pressure levels and clinical ultrasound (inferior vena cava and portal Doppler). This strategy will be maintained during the first 72 hours of admission, with a thorough analysis of congestion and diuretic response being conducted.

Вмешательства

• Препарат Furosemide 20 Milligrams
  Decongestive therapy with e.v. furosemide +/- hydrochlorothiazide will be adjusted by intraabdominal pressure and/or point of care ultrasound

Первичные конечные точки

• Significant reduction in congestion (ADVOR scale) [Срок оценки: After the first 72 hours of endovenous loop diuretic treatment]

Вторичные конечные точки (8)

• Significant pulmonary congestion reduction through lung ultrasound assessment (b-lines) [Срок оценки: From time to randomization until the first 72 hours of endovenous loop diuretics treatment at the Internal Medicine ward]
• Significant intravascular congestion reduction through venous excess ultrasound score (VEXUS score) [Срок оценки: After the first 72 hours of endovenous loop diuretic treatment]
• Total diuresis response [Срок оценки: After the first 72 hours of endovenous loop diuretic treatment]
• Total dose of diuretic treatment [Срок оценки: After the first 72 hours of endovenous loop diuretic treatment]
• Number of patients treated for worsening heart failure [Срок оценки: From date of discharge until 30-days post-hospitalization visit. From date of discharge until 90-days post-hospitalization visit. (cut-off period 1-year)]
• Total number of patients with cardiovascular death [Срок оценки: From date of discharge until the date of cardiovascular death (cut-off period 1 year)]
• guided directed medical therapy (GDMT) [Срок оценки: From date of admission up to discharge, from date of discharge up to 30 days after and from date of discharge up to 90 days (cut-off period 1-year)]
• length of stay [Срок оценки: From date of randomization until date of discharge (cut-off period 4 weeks)]

Критерии участия

Критерии включения

• Men or women over 18 years of age.
• Diagnosis of heart failure (HF) based on the latest HF guidelines published in 2022.
• N-terminal pro b-type natriuretic peptide (NT-proBNP) \> 1000 pg/mL or Brain Natriuretic Peptide (BNP) \> 250 pg/mL.
• Placement of a urinary catheter to allow for the measurement of intra-abdominal pressure.
• Intravascular or mixed congestion pattern, defined as the presence of one or more clinical signs of congestion (edema, ascites, and/or pleural effusion).
• Signed informed consent

Критерии исключения

• Patient with a stay in the Internal Medicine department \> 24 hours.
• Absence of sufficient clinical congestion (ADVOR score = 0 at the time of randomization).
• Patient\'s refusal to participate in the clinical trial.
• Inability or contraindication for urinary catheter placement.
• Systolic blood pressure at admission \< 100 mmHg.
• Heart rate at admission \> 170 beats per minute (bpm).
• Cardiogenic shock.
• Acute myocardial ischemia.
• Patients receiving renal replacement therapy (ultrafiltration or peritoneal dialysis).
• Kidney transplant recipients.
• Serum hemoglobin \< 9 g/dL.
• Pregnancy or breastfeeding.
• History of hypersensitivity to hydrochlorothiazide or furosemide.
• Patients admitted from the Intensive Care Unit.
• Patients with recent cardiac surgery (within the last year) or heart transplant recipients.
• Need for inotropic support to maintain adequate cardiac and/or renal output.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 2 центра

• Hospital Clínico Universitario Lozano Blesa — Zaragoza
• Hospital Clínico Universitario Lozano Blesa — Zaragoza

Идентификаторы

NCT: NCT07008365 · PI23/00797

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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