Impact of Clinical Ultrasound in Patients With Heart Failure Treated in Home Hospitalization

NCT05042752 | Unknown

• 1 other identifier: HRS-AHF-CU
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess whether clinical ultrasound (CU)-guided treatment in acute heart failure (AHF) is superior to the standard care (SC)-guided treatment. We would like to see if using a portable ultrasound to guide diuretic therapy for AHF patients will prevent hospital readmissions in the setting of hospitalization at home (HAH). This study will use a handheld ultrasound called IVIZ-Sonosite and aims to see whether changing diuretic therapy based on the performance of the ultrasound will result in the less hospitalizations for heart failure as compared to performing just SC-guided therapy.

Conditions

Acute Heart Failure (AHF)

Keywords

Acute heart failure; Ultrasound; Hospital at home; Readmision

Outcome Measures

Primary Outcomes (2)

• Readmission due to AHF

  Admission on the internal medicine ward for more than 24 hours due to AHF after being discharge from the AHA unit. We do not consider admission in the emergency room due to AHF after being discharge from the AHA unit.

  At 30 days and 60 days

• Mortality due to AHF

  Death related to an AHF episode after being discharge from the AHA unit.

  At 30 days and 60 days

Secondary Outcomes (2)

• Readmission due to a cause different to AHF.

  At 30 days and 60 days

• Mortality due to a cause different to AHF

  At 30 days and 60 days.

Other Outcomes (1)

• Cumulative event

  At one or two months

Study Arms (2)

No intervention arm

NO INTERVENTION

Standard care of AHF on a patient admitted on a HAH unit consists in physical examination and basic complementary tests

Experimental arm

EXPERIMENTAL

Clinical ultrasound on HAH admitted patient. Clinical handheld Ultrasound consists of inferior vena cava diameter measurement and lung ultrasound protocol in order to guided Diuretic Therapy

Procedure: CLINICAL ULTRASOUND

Interventions

CLINICAL ULTRASOUND PROCEDURE

The intervention group will receive the standard care of treatment in AHF and the performance of CU.

Experimental arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• AHA documented
• HAH admission
• Informed consent
• or more CU on the intervention group being one the day of admission

You may not qualify if:

• Life expectancy below 6 months
• Active tumors
• Interstitial lung disease
• Respiratory distress
• Pulmonary concussion
• Inotropic drugs on admission
• Patients coming from intensive care unit
• Intolerance or allergy to diuretic treatment

Sponsors & Collaborators

• Lara Palacios: lead

Study Sites (1)

Hospital Reina Sofia

Tudela, Navarre, 31500, Spain

RECRUITING

Study Officials

• LARA PALACIOS GARCIA, MD

  Hospital Reina Sofia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LARA PALACIOS GARCIA, MD

CONTACT

+(34) 8484434000; lara.palacios.garcia@navarra.es

RUTH GARCIA REY

CONTACT

+(34) 848422163; ruth.garcia.rey@navarra.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: September 13, 2021
• Study Start: January 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: March 1, 2022
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)