Impact of Clinical Ultrasound in Patients With Heart Failure Treated in Home Hospitalization (AHF-CU)

Impact of Clinical Ultrasound in Patients With Heart Failure Treated in Home Hospitalization (AHF-CU)

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Heart Failure (AHF)
• Intervention / Treatment: Procedure: CLINICAL ULTRASOUND

Detailed Description

AHF remains a leading cause of death in industrialized countries. Despite advances in medical treatment, an estimated 250,000-300,000 AHF patients are hospitalized in the United States each year for symptoms caused by low cardiac output. Although the events that cause acute decompensation are multifactorial, the common pathway associated with decreased ventricular function are autonomic dysfunction and fluid retention. It has been previously suggested that an estimated 50%-66% of CHF hospitalizations may be preventable with improved monitoring of fluid volume status. In Spain, more than 10% of discharged patients are readmitted within 30 days. AHF is one of the most frequent reasons for readmission, mainly because of congestion-related symptoms. The size and shape of the inferior vena cava and the presence of B lines have proven to be effective to estimate volume overload and to guide diuretic treatment in AHF on a hospital setting. At the same time, technology is quickly evolving and new approaches for clinical care are arising.

The aim of this study is two compare SC-guided therapy vs CU-guided therapy in AHF patients admitted on a HAH. We designed an open label clinical trial, in which patients are randomized into two groups: "ultrasound group" who undergoes CU together with SC and "control group" who undergoes SC only. Diuretic treatment will be tailored according to the findings of the SC together with the CU or according to the findings of the SC respectively. A total of 140 patients will be recruited, 70 patients on each arm. The outcome variables are readmission for AHF and other causes, mortality for AHF and other causes, and the combined event of readmission for AHF and mortality for AHF at one month and two months. The CU protocol will include both lung ultrasound and inferior vena cava measurement and will be performed with an ultraportable device (IVIZ-Sonosite). Standard care will involve physical examination and basic complementary tests.

The way patients end up admitted to HAH are transferences from the emergency room, from the internal medicine ward, from the clinics and from primary care. During admission, daily visits are carried out by the nursing staff (except when clinical stability and no need to intravenous treatment infusions) and every two days by the medical team. Admission in the HAH is always voluntary and patients can decide to return to hospital during HAH stay. In the HAH unit, there is a 24-hour telephone service coordinated by a specialized nurse on call.

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: LARA PALACIOS GARCIA, MD; Phone Number: 51067 +(34) 8484434000; Email: lara.palacios.garcia@navarra.es
• Study Contact Backup: Name: RUTH GARCIA REY; Phone Number: +(34) 848422163; Email: ruth.garcia.rey@navarra.es

Study Locations

• Spain
  • Navarra
    • Tudela, Navarra, Spain, 31500
      • Recruiting
      • Hospital Reina Sofia
      • Contact: LARA PALACIOS GARCIA, MD; Phone Number: 51067 +(34) 8484434000; Email: lara.palacios.garcia@navarra.es
      • Contact: RUTH GARCIA REY; Phone Number: +(34) 848422163; Email: ruth.garcia.rey@navarra.es
      • Principal Investigator: LARA PALACIOS GARCIA, MD
      • Sub-Investigator: PABLO RUIZ SADA, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No intervention arm; Standard care of AHF on a patient admitted on a HAH unit consists in physical examination and basic complementary tests
Experimental: Experimental arm; 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; The intervention group will receive the standard care of treatment in AHF and the performance of CU.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Readmission due to a cause different to AHF.	Admission on the internal medicine ward for more than 24 hours after being discharge from the AHA unit due to a cause different to AHF. We do not consider admission in the emergency room after being discharge from the AHA unit due to a cause different to AHF	At 30 days and 60 days
Mortality due to a cause different to AHF	Any death related to a cause different to AHF after being discharge from the AHA unit.	At 30 days and 60 days.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative event	At least one AHA readmission or mortality due to AHA	At one or two months

Collaborators and Investigators

• Sponsor: Lara Palacios
• Investigators: Principal Investigator: LARA PALACIOS GARCIA, MD, Hospital Reina Sofia

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: September 3, 2021
• First Submitted That Met QC Criteria: September 3, 2021
• First Posted (Actual): September 13, 2021

Study Record Updates

• Last Update Posted (Actual): September 29, 2021
• Last Update Submitted That Met QC Criteria: September 23, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Ultrasound; Acute heart failure; Hospital at home; Readmision
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: HRS-AHF-CU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No