The Role of intraABDOminal Pressure and Point Of Care UltraSound to Guide Decongestive Therapy in Heart Failure
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Significant reduction in congestion (ADVOR scale)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women over 18 years of age.
- •Diagnosis of heart failure (HF) based on the latest HF guidelines published in
- •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
排除标准
- •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.
研究组 & 干预措施
Treatment guided by intra-abdominal pressure values
Decongestive treatment will be adjusted according to intraabdominal pressure values (IAP) and/or point of care ultrasound:
Patients with IAP < 8 mmHg (normal): The intravenous diuretic dose will be twice the patient's previous oral dose. If no diuretics were taken previously, 20 mg of furosemide will be administered every 12 hours.
Patients with IAP between 8 and 12 mmHg (moderately elevated): furosemide will be administered in combination with hydrochlorothiazide Patients wiht IAP > 12: Furosemide will be initiated as a continuous infusion along with hydrochlorothiazide
干预措施: Furosemide 20 Milligrams (Drug)
结局指标
主要结局
Significant reduction in congestion (ADVOR scale)
时间窗: After the first 72 hours of endovenous loop diuretic treatment
To evaluate the significant reduction in congestion (ADVOR Scale) after the first 72 hours of intravenous diuretic treatment in the hospital ward, comparing the standard treatment group with the intervention group (intra-abdominal pressure and ultrasound). ADVOR Scale: Oedema: No oedema (0 points), Trace oedema (1 point), Clear pitting oedema (2 points), Visual deformation above ankle (3 points), Visual deformation above knee (4 points). Pleural effusion: No pleural effusion (0 points), Minor (2 points), Major (3 points) Ascites: No ascites (0 points), Minor ascites (2 points), Significant ascites (3 points) TOTAL SCORE: Oedema score + Pleural effusion + Ascitis. Minimum 0 points; Maximum 10 points
次要结局
- Significant pulmonary congestion reduction through lung ultrasound assessment (b-lines)(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)(After the first 72 hours of endovenous loop diuretic treatment)
- Total diuresis response(After the first 72 hours of endovenous loop diuretic treatment)
- Total dose of diuretic treatment(After the first 72 hours of endovenous loop diuretic treatment)
- Number of patients treated for worsening heart failure(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(From date of discharge until the date of cardiovascular death (cut-off period 1 year))
- guided directed medical therapy (GDMT)(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(From date of randomization until date of discharge (cut-off period 4 weeks))