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.
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
- 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
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.
- Conditions
- Acute Heart Failure (AHF)
- 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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: CLINICAL ULTRASOUND |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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)
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
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.
- First posted13 Sep 2021
- Study start1 Jan 2021
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Heart Failure (AHF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Lara Palacios
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lara Palacios, Fundacion Miguel Servet
- Investigators
- LARA PALACIOS GARCIA, MD, Principal investigator, Hospital Reina Sofia
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Clinical Ultrasound in Patients With Heart Failure Treated in Home Hospitalization (AHF-CU)
- ClinicalTrials.gov ID
- NCT05042752
- Acronym / sponsor ID
- AHF-CU / HRS-AHF-CU
- Conditions
- Acute Heart Failure (AHF)
- Keywords
- Acute heart failure, Ultrasound, Hospital at home, Readmision
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Lara PalaciosUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 13 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Procedure: CLINICAL ULTRASOUNDClinical 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- AHA documented
- HAH admission
- Informed consent
- 2 or more CU on the intervention group being one the day of admission
Key exclusion criteria (8 listed)
- Life expectancy below 6 months
- Active tumors
- Interstitial lung disease
- Respiratory distress
- Pulmonary concussion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CLINICAL ULTRASOUNDThe intervention group will receive the standard care of treatment in AHF and the performance of CU. | Procedure or surgery | Experimental arm |
Primary outcome
Readmission due to AHF
Time frame: At 30 days and 60 days
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.
Mortality due to AHF
Time frame: At 30 days and 60 days
Death related to an AHF episode after being discharge from the AHA unit.
2 secondary outcomes
Readmission due to a cause different to AHF.
Time frame: At 30 days and 60 days
Mortality due to a cause different to AHF
Time frame: At 30 days and 60 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LARA PALACIOS GARCIA, MD principal investigator
Hospital Reina Sofia
1 site in 1 country: see every site and its status.
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.