Acute Heart FailureNCT01264159
Preemptive Lung Impedance-guided Therapy of Evolving Acute Heart Failure in Acute Myocardial Infarction Patients
A study testing Lung impedence-guided therapy and Usual treatment of patients with developing acute heart failure in people with Acute 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?
- Any age
- Conditions the study is for
- Acute Heart Failure
- What is being tested?
- Lung impedence-guided therapy and Usual treatment of patients with developing acute heart failure
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2011to 1 Jul 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients hospitalized in the ICCU for acute myocardial infarction and developing acute heart failure during their hospitalization
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 impedence-guided therapy may prevent the development of overt acute heart failure and improve their clinical outcome.
- Conditions
- Acute Heart Failure
- Being tested
- Lung impedence-guided therapy, Usual treatment of patients with developing acute heart failure
- Keywords
- Developing acute heart failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung impedence-guided therapyDevice
Usual treatment of patients with developing acute heart failureOther
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Not described Receives: Other: Usual treatment of patients with developing acute heart failure |
| Lung impedence-guided treatment | Active comparator | Not described Receives: Device: Lung impedence-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 impedence-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 posted21 Dec 2010 (estimated)
- Study start1 Jan 2011
- Primary completion1 Jan 2015
- Study completion1 Jul 2015
Why it stopped: The principle investigator decided to change the protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 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
- NCT01264159
- Sponsor's protocol ID
- 0090-10-HYMC
- Status last verified
- Jun 2020
- First submitted
- 20 Dec 2010
- Last updated
- 11 Jun 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preemptive Lung Impedance-guided Therapy of Evolving Acute Heart Failure in Acute Myocardial Infarction Patients
- ClinicalTrials.gov ID
- NCT01264159
- Acronym / sponsor ID
- 0090-10-HYMC
- Conditions
- Acute Heart Failure
- Keywords
- Developing acute heart failure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The principle investigator decided to change the protocol
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 1 Jan 2015 (actual)
- Study completion
- 1 Jul 2015 (actual)
- First posted
- 21 Dec 2010 (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 impedence-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
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: Usual treatment of patients with developing acute heart failure |
| Lung impedence-guided treatment | Active comparator | Device: Lung impedence-guided therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients hospitalized in the ICCU for acute myocardial infarction and developing acute heart failure during their hospitalization
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 |
|---|---|---|
| Lung impedence-guided therapy | Device | Lung impedence-guided treatment |
| Usual treatment of patients with developing acute heart failure | Other | Control |
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 impedence-guided treatments
Time frame: Three years
Results and safety
The study was stopped early (reason given: The principle investigator decided to change the protocol). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 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 study testing Lung impedence-guided therapy and Usual treatment of patients with developing acute heart failure in people with Acute 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: stopped early, as of the sponsor's last update on 11 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. Some participants in this study may receive a placebo. 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?
The study was stopped early (reason given: The principle investigator decided to change the protocol). Results are not available in the source record.
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 11 Jun 2020.