Heart FailurePhase 3NCT01616121
Preemptive Lung Impedance-Guided Therapy in Evolving Acute Heart Failure in Acute Myocardial Infarction Patients
A Phase 3 study testing Usual treatment of patients with developing acute heart failure and Lung Impedance-Guided Therapy in people with Heart Failure, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
It is well-known that 20-25% of patients hospitalized for acute myocardial infarction will develop acute heart failure during their hospitalization. Currently, the investigators have no reliable parameter for prediction of evolving acute heart failure in such a group of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Usual treatment of patients with developing acute heart failure and Lung Impedance-Guided Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 654 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jun 2002to 1 Jul 2014
- 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
- Patients hospitalized in the ICCU for acute myocardial infarction and developing acute heart failure
Who cannot join
- Patients with acute myocardial infarction with clinical and radiological signs of acute heart failure at admission
Trial locations and contacts
1 site in 1 country.
About this study
It is well-known that 20-25% of patients hospitalized for acute myocardial infarction will develop acute heart failure during their hospitalization. Currently, the investigators have no reliable parameter for prediction of evolving acute heart failure in such a group of patients. As a result, the investigators have no way of preventing acute heart failure. Treatment of these patients only begins after appearance of clinical signs of acute heart failure. Lung impedance monitoring may be a good non-invasive parameter for prediction of evolving acute heart failure. This study will attempt to address whether preemptive lung impedance-guided therapy may prevent the development of overt acute heart failure and improve their clinical outcome.
- Conditions
- Heart Failure
- Being tested
- Usual treatment of patients with developing acute heart failure, Lung Impedance-Guided Therapy
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual treatment of patients with developing acute heart failureOther
Lung Impedance-Guided TherapyDevice
Non-invasive lung impedance monitor (RSMM Company, Tel Aviv, Israel)
| Study group | Role | What they receive |
|---|---|---|
| Conventional Treatment Heart Failure | Active comparator | Conventional Treatment Receives: Other: Usual treatment of patients with developing acute heart failure |
| Lung Impedance-Guided Therapy | Experimental | Lung Impedance-Guided Therapy Receives: Device: Lung Impedance-Guided Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of acute heart failure development in acute MI patients
Measured: Three years
Secondary outcomes (1)
Improvement of clinical outcome in patients with lung impedance-guided treatments
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2012 (estimated)
- Study start1 Jun 2002
- Primary completion1 Jul 2014
- Study completion1 Jul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this study the interventional group was treated preemptively according to the lung-impedance protocol and the control group was treated only according to clinical assessment.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 654 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01616121
- Sponsor's protocol ID
- 0037-12-HYMC
- Status last verified
- Jun 2020
- First submitted
- 31 May 2012
- Last updated
- 19 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preemptive Lung Impedance-Guided Therapy in Evolving Acute Heart Failure in Acute Myocardial Infarction Patients
- ClinicalTrials.gov ID
- NCT01616121
- Acronym / sponsor ID
- 0037-12-HYMC
- Conditions
- Heart Failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 654 participants (actual)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- 1 Jun 2002 (actual)
- Primary completion
- 1 Jul 2014 (actual)
- Study completion
- 1 Jul 2014 (actual)
- First posted
- 11 Jun 2012 (estimated)
- 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.
It is well-known that 20-25% of patients hospitalized for acute myocardial infarction will develop acute heart failure during their hospitalization. Currently, the investigators have no reliable parameter for prediction of evolving acute heart failure in such a group of patients. As a result, the investigators have no way of preventing acute heart failure. Treatment of these patients only begins after appearance of clinical signs of acute heart failure. Lung impedance monitoring may be a good non-invasive parameter for prediction of evolving acute heart failure. This study will attempt to address whether preemptive lung impedance-guided therapy may prevent the development of overt acute heart failure and improve their clinical outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- In this study the interventional group was treated preemptively according to the lung-impedance protocol and the control group was treated only according to clinical assessment.
| Arm | Type | Receives |
|---|---|---|
| Conventional Treatment Heart Failure | Active comparator | Other: Usual treatment of patients with developing acute heart failureConventional Treatment |
| Lung Impedance-Guided Therapy | Experimental | Device: Lung Impedance-Guided TherapyLung Impedance-Guided Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients hospitalized in the ICCU for acute myocardial infarction and developing acute heart failure
Key exclusion criteria (1 listed)
- Patients with acute myocardial infarction with clinical and radiological signs of acute heart failure at admission
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 |
|---|---|---|
| Usual treatment of patients with developing acute heart failure | Other | Conventional Treatment Heart Failure |
| Lung Impedance-Guided TherapyNon-invasive lung impedance monitor (RSMM Company, Tel Aviv, Israel) | Device | Lung Impedance-Guided Therapy |
Primary outcome
Prevention of acute heart failure development in acute MI patients
Time frame: Three years
1 secondary outcome
Improvement of clinical outcome in patients with lung impedance-guided treatments
Time frame: Three years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Usual treatment of patients with developing acute heart failure and Lung Impedance-Guided Therapy in people with Heart Failure, 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 1 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: finished, as of the sponsor's last update on 19 Jun 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention of acute heart failure development in acute MI patients (time frame: Three years). 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 19 Jun 2020.