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Acute Heart Failure (AHF)AHF-CUNCT05042752

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

A study testing CLINICAL ULTRASOUND in people with Acute Heart Failure (AHF), run by Lara Palacios at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Heart Failure (AHF)
What is being tested?
CLINICAL ULTRASOUND
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
1 siteSpain
Study dates
1 Jan 2021to 1 Mar 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site, 1 recruiting
  • Hospital Reina Sofia

    Tudela, Navarre, 31500

    LARA PALACIOS GARCIA, MD, +(34) 8484434000 ext. 51067, lara.palacios.garcia@navarra.es

    RUTH GARCIA REY, +(34) 848422163, ruth.garcia.rey@navarra.es

    Recruiting

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Being tested
CLINICAL ULTRASOUND
Keywords
Acute heart failure, Ultrasound, Hospital at home, Readmision

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CLINICAL ULTRASOUNDProcedure or surgery

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

Study groups in NCT05042752
Study groupRoleWhat they receive
No intervention armNo interventionStandard care of AHF on a patient admitted on a HAH unit consists in physical examination and basic complementary tests
Experimental armExperimentalClinical 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
Receives: Procedure: CLINICAL ULTRASOUND

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At 30 days and 60 days

  2. Mortality due to AHF

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

    Measured: At 30 days and 60 days

Secondary outcomes (2)
  1. 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

    Measured: At 30 days and 60 days

  2. Mortality due to a cause different to AHF

    Any death related to a cause different to AHF after being discharge from the AHA unit.

    Measured: At 30 days and 60 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2021
  2. Study start1 Jan 2021
  3. Primary completion1 Jan 2022 (estimated)
  4. Study completion1 Mar 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05042752
Sponsor's protocol ID
HRS-AHF-CU
Acronym
AHF-CU
Status last verified
Sep 2021
First submitted
3 Sep 2021
Last updated
29 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing CLINICAL ULTRASOUND in people with Acute Heart Failure (AHF), run by Lara Palacios at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact LARA PALACIOS GARCIA, MD (+(34) 8484434000 ext. 51067, lara.palacios.garcia@navarra.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Readmission due to AHF (time frame: At 30 days and 60 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.

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