Heart Failure AcutePhase 3HOPE-HFNCT04080388
How to Prevent Heart Failure Readmission by Using Lung Impedance Device (HOPE-HF Study)
A Phase 3 study testing Lung Impedance Device and Anti-congestive treatment in people with Heart Failure Acute, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
The readmission of Heart Failure (HF) patients for exacerbation HF within 30-day is unmet goal. The mail reason for readmission is excessive accumulation of fluid in patient's lung. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure Acute
- What is being tested?
- Lung Impedance Device and Anti-congestive treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2019to Sep 2021
- Phase
- Phase 3
- 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
- Acute Heart Failure Patients Prior to Hospital Discharge
Who cannot join
- No Cardiac Resynchronization Device Implanted During Current Hospitalization
- Estimated glomerular filtrating rate (GFR) less than 30 ml/min
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hillel Yaffe Medical Center
Hadera, 38100
Michael Kleiner Shochat, MD, PhD, 972-50-6246926
About this study
The readmission of Heart Failure (HF) patients for exacerbation HF within 30-day is unmet goal. The mail reason for readmission is excessive accumulation of fluid in patient's lung. According our data (1,2) around 40% of HF patient have excessive lung fluid at discharge from HF hospitalization ("unacceptable" residual congestion on discharge). In other words, around 40% patients are discharged from HF hospitalization prematurely when they are not ready to be discharged. Only 60% of HF patients are discharged from HF admission with "acceptable" level of residual pulmonary congestion (2). There are some techniques to assess "readiness" of HF patients for discharge. Pulmonary congestion (lung fluid accumulation) may be assessed non-invasively by measurement Brain Natriuretic Peptide (BNP), (3,4), by lung ultrasound (LUS), (5-7) and by Lung Impedance (LI) method (1,2). LUS is operator depended technique. LI and BNP techniques are most reliable methods (2) and easy to use.
- Conditions
- Heart Failure Acute
- Being tested
- Lung Impedance Device, Anti-congestive treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung Impedance DeviceDiagnostic test
The non-invasive lung impedance device enables assessment of the level of pulmonary congestion and can be an indication for additional anti-congestive treatment.
Anti-congestive treatmentDrug
Also called Diuretic therapy
Continuation of in-hospital anti-congestive treatment
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Patients prior to discharge for acute heart failure admission will be examined with a lung impedance device for their suitability for discharge according to their level of pulmonary congestion. Only patients who are unsuitable for discharge according to the lung impedance assessment will be enrolled in the study. The control group (half of the patients) will be discharged without additional intervention. Receives: Diagnostic Test: Lung Impedance Device |
| Interventional Group | Active comparator | Patients prior to discharge for acute heart failure admission will be examined with a lung impedance device for their suitability for discharge according to their level of pulmonary congestion. Only patients who are unsuitable for discharge according to the lung impedance assessment will be enrolled in the study. The interventional group (half of the patients) will continue anti-congestive treatment while hospitalized until achieving a suitable level of decongestion. Receives: Diagnostic Test: Lung Impedance Device; Drug: Anti-congestive treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of heart failure re-admission
30-day re-admission rates will be compared between the two groups
Measured: 30 days
Prevention of heart failure re-admission
90-day re-admission rates will be compared between the two groups
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study startSep 2019 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure AcuteStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Karina Zilber, MD, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04080388
- Sponsor's protocol ID
- HYMC-0073-19
- Acronym
- HOPE-HF
- Status last verified
- Sep 2019
- First submitted
- 28 Aug 2019
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How to Prevent Heart Failure Readmission by Using Lung Impedance Device (HOPE-HF Study)
- ClinicalTrials.gov ID
- NCT04080388
- Acronym / sponsor ID
- HOPE-HF / HYMC-0073-19
- Conditions
- Heart Failure Acute
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Sep 2019 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 6 Sep 2019 (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 readmission of Heart Failure (HF) patients for exacerbation HF within 30-day is unmet goal. The mail reason for readmission is excessive accumulation of fluid in patient's lung. According our data (1,2) around 40% of HF patient have excessive lung fluid at discharge from HF hospitalization ("unacceptable" residual congestion on discharge). In other words, around 40% patients are discharged from HF hospitalization prematurely when they are not ready to be discharged. Only 60% of HF patients are discharged from HF admission with "acceptable" level of residual pulmonary congestion (2). There are some techniques to assess "readiness" of HF patients for discharge. Pulmonary congestion (lung fluid accumulation) may be assessed non-invasively by measurement Brain Natriuretic Peptide (BNP), (3,4), by lung ultrasound (LUS), (5-7) and by Lung Impedance (LI) method (1,2). LUS is operator depended technique. LI and BNP techniques are most reliable methods (2) and easy to use.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Diagnostic Test: Lung Impedance DevicePatients prior to discharge for acute heart failure admission will be examined with a lung impedance device for their suitability for discharge according to their level of pulmonary congestion. Only patients who are unsuitable for discharge according to the lung impedance assessment will be enrolled in the study. The control group (half of the patients) will be discharged without additional intervention. |
| Interventional Group | Active comparator | Diagnostic Test: Lung Impedance Device, Drug: Anti-congestive treatmentPatients prior to discharge for acute heart failure admission will be examined with a lung impedance device for their suitability for discharge according to their level of pulmonary congestion. Only patients who are unsuitable for discharge according to the lung impedance assessment will be enrolled in the study. The interventional group (half of the patients) will continue anti-congestive treatment while hospitalized until achieving a suitable level of decongestion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Acute Heart Failure Patients Prior to Hospital Discharge
Key exclusion criteria (2 listed)
- No Cardiac Resynchronization Device Implanted During Current Hospitalization
- Estimated glomerular filtrating rate (GFR) less than 30 ml/min
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 |
|---|---|---|
| Lung Impedance DeviceThe non-invasive lung impedance device enables assessment of the level of pulmonary congestion and can be an indication for additional anti-congestive treatment. | Diagnostic test | Control Group, Interventional Group |
| Anti-congestive treatmentAlso: Diuretic therapyContinuation of in-hospital anti-congestive treatment | Drug | Interventional Group |
Primary outcome
Prevention of heart failure re-admission
Time frame: 30 days
30-day re-admission rates will be compared between the two groups
Prevention of heart failure re-admission
Time frame: 90 days
90-day re-admission rates will be compared between the two groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- 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.
Karina Zilber, MD principal investigator
Hillel Yaffe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lung Impedance Device and Anti-congestive treatment in people with Heart Failure Acute, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 1 inclusion and 2 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 6 Sep 2019. 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 Israel. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Michael Kleiner Shochat, MD, PhD (972-50-6246926, shochat1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention of heart failure re-admission (time frame: 30 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 6 Sep 2019.