Acute Heart Failure, Cardio-Renal Syndrome, Congestive Heart Failure, Intraabdominal Hypertension
Conditions
Keywords
Point of care Ultrasound (POCUS), Acute Heart Failure, Cardio-renal syndrome, Intraabdominal pressure, Diuretic treatment
Brief summary
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.
Interventions
DRUGFurosemide 20 Milligrams
Decongestive therapy with e.v. furosemide +/- hydrochlorothiazide will be adjusted by intraabdominal pressure and/or point of care ultrasound
Sponsors
Instituto de Investigación Sanitaria Aragón
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
After conducting an initial comprehensive evaluation and confirming the inclusion and exclusion criteria, along with obtaining the necessary informed consent (screening), the patient will be randomized within the first 24 hours of admission into one of the two treatment groups with the aim of determining whether a diuretic treatment strategy based on intra-abdominal pressure and clinical ultrasound is superior to the conventional diuretic treatment strategy for resolving systemic congestion after the first 72 hours of admission.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Significant reduction in congestion (ADVOR scale) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Significant intravascular congestion reduction through venous excess ultrasound score (VEXUS score) | After the first 72 hours of endovenous loop diuretic treatment | To evaluate the significant reduction in intravascular congestion (inferior vena cava diameter and venous excess ultrasound protocol) after the first 72 hours of intravenous diuretic treatment in the hospital ward, comparing the standard of care treatment group with the interventional group (intra-abdominal pressure and ultrasound). VEXUS score * Grade 0: No congestion; inferior vena cava vein (IVC) diameter < 2 cms * Grade 1: Mild congestion, IVC 2> cms + any combination of normal or mildly abnormal waveforms of doppler veins explored. * Grade 2: Moderate congestion, IVC > 2 cms + at least one severely abnormal pattern of doppler veins explored. * Grade 3: Severe congestion, IVC > 2cms + two or more severely abnormal waveforms of doppler veins explored. Minimum 0 points; Maximum 3 points |
| Total diuresis response | After the first 72 hours of endovenous loop diuretic treatment | To evaluate the diuretic response (total urine volume/total dose of furosemide administered) 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). |
| Total dose of diuretic treatment | After the first 72 hours of endovenous loop diuretic treatment | To compare the days and doses of intravenous loop diuretics and hydrochlorothiazide used during the first 72 hours of hospitalization between the standard treatment group and the intervention group. |
| 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 | To evaluate the complete resolution of pulmonary congestion as assessed by ultrasound (B-lines) after the first 72 hours of intravenous diuretic treatment in the hospital ward, comparing the standard of care treatment group with the interventional group (intra-abdominal pressure and ultrasound). The degree of pulmonary tissue congestion will be quantified using clinical ultrasound. Eight quadrants (four left and four right) will be examined. A quadrant will be considered positive for pulmonary tissue congestion if three or more B-lines are detected. Minimum: 0 quadrants; Maximum 8 quadrants |
| Total number of patients with cardiovascular death | From date of discharge until the date of cardiovascular death (cut-off period 1 year) | Differences in cardiovascular death incidence |
| 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) | Prevalence of GDMT prescribed at discharge according to left ventricular ejection fraction and actual heart failure guidelines |
| length of stay | From date of randomization until date of discharge (cut-off period 4 weeks) | Differences in length of stay between both arms |
| 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) | Differences in heart failure worsening (defined as the need for intravenous loop diuretic treatment after hospital discharge, whether in a day hospital, emergency department, or due to new hospital admissions at 30 and 90 days) between the two groups. |
Countries
Spain
Outcome results
None listed