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Studies

Interventional Recruiting Phase 3

NCT07008365 on ClinicalTrials.gov

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

  • Sponsor: Instituto de Investigación Sanitaria Aragón
  • Enrollment: 168 (Estimated)
  • Study start: 2025-03-10 (Actual)
  • Primary completion: 2026-11-30 (Estimated)
  • Study completion: 2026-12-31 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: 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.
  • Masking: None
  • PrimaryPurpose: 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.

Conditions

  • Acute Heart Failure
  • Congestive Heart Failure
  • Intraabdominal Hypertension
  • Cardio-Renal Syndrome

Intervention / Treatment

  • Drug: Furosemide 20 Milligrams

Primary Outcome Measures

  • 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

Countries

Spain

Locations and Investigators

  • Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain (Recruiting)
    • Jorge Rubio-Gracia, M.D.PhD
  • Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain (Not yet recruiting)
    • Jorge Rubio-Gracia, MD.PhD
    • Marta Sanchez-Marteles, MD.PhD
    • Juan Ignacio Pérez-Calvo, MD.PhD
    • Esther Montero-Hernández, MD.PhD (Principal Investigator)
    • José Pérez-Silvestre, MD.PhD (Principal Investigator)
    • Pau Llacer-Iborra, MD.PhD (Principal Investigator)
    • Juan Torres-Macho, MD.PhD (Principal Investigator)
    • Manuel Méndez-Bailon, MD.PhD (Principal Investigator)
    • Jose Luis Morales-Rull, MD.PhD (Principal Investigator)
    • Ana Sabín-Collado, MD.PhD (Principal Investigator)
    • Antonio Espino-Montoro, MD.PhD (Principal Investigator)
    • Prado Salamanca-Bautista, MD.PhD (Principal Investigator)
    • Noelia Fernandez-Villa, MD.PhD (Principal Investigator)
    • Isabel Torres-Courchoud, MD.PhD (Principal Investigator)
    • Miguel Angel Vazquez-Ronda, MD (Principal Investigator)
    • Rocío Martínez-Gutierrez, MD (Principal Investigator)
    • Jorge Rubio-Gracia, MD-PhD (Principal Investigator)