Heart FailureNCT02406716
Semaphorins 3A and 4D Levels in Heart Failure Patients
An observational study of Heart Failure, run by Bnai Zion Medical Center.
Trial summary
This study hypothesis is that Semaphorins 3A and 4D levels are overexpressed in patients with heart failure. Study protocol: Hospitallized patients with new onset or previously diagnosed heart failure will be recruited to the study. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Biospecimen retention
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to May 2017
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with new onset or previously diagnosed heart failure
Who may be able to join
- Patients with new onset or previously diagnosed heart failure.
- Heart failure diagnosis can be based on clinical judgment, echocardiography or elevated BNP levels
Who cannot join
- Patients with acute myocardial infarction diagnosed clinicly and labratory
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Semaphorins 3A and 4D Levels in Heart Failure Patients: Pathogenesis and Clinical Correlation
This study hypothesis is that Semaphorins 3A and 4D levels are overexpressed in patients with heart failure. Study protocol:
Hospitallized patients with new onset or previously diagnosed heart failure will be recruited to the study. Control group will include healthy people with no medical records or chronic treatment at the same age range. After signing an informed constent form, full medical history and blood samples will be collected. A second blood sample will be collected 8 weeks later, assuming the patient was discharged and not hospitalized since than. The blood samples will be analyzed by Bnai Zion Medical Center Immunology labs for the above semaphorins levels in the heart failure group and control group. Statistical analysis will then commence for possible correlatoion with different clinical parameters.
Read the detailed description
In few previous published studies, Semaphorins 3A levels are overexpressed in patients with heart failure. The aim of our study is the compare semaphorin 3A and 4D in patients with acute decompansated heart failure with healthy donors. Second aim is to compare semaphorin level in the same patients in time of hospitalization and few weeks later when the heart failure presumingly controled. Statistical analysis will then commense for possible correlatoion with different clinical parameters like NYHA (new york heart association) status of the patient, lenghts of hospitalization and BNP (brain natriuretic peptide) levels at time of admition.
- Conditions
- Heart Failure
- Being tested
- Biospecimen retention
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen retentionOther
| Study group | Role | What they receive |
|---|---|---|
| HF | Heart failure patients Receives: Other: Biospecimen retention | |
| Controls | Healthy donors Receives: Other: Biospecimen retention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Semaphrone 3A and 4D levels
Measured: one year
Secondary outcomes (1)
BNP level
Brain natriuretic peptide level in patient plasma
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionMay 2016 (estimated)
- Study completionMay 2017 (estimated)
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Zahava Vadas, MD. PHD., Principal investigator, Bnai Zion Medical Center, Immunology devision
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02406716
- Sponsor's protocol ID
- NW-2401-ZV
- Status last verified
- Mar 2015
- First submitted
- 29 Mar 2015
- Last updated
- 2 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Semaphorins 3A and 4D Levels in Heart Failure Patients: Pathogenesis and Clinical Correlation
- ClinicalTrials.gov ID
- NCT02406716
- Acronym / sponsor ID
- NW-2401-ZV
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- Apr 2015
- Primary completion
- May 2016 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 2 Apr 2015 (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.
This study hypothesis is that Semaphorins 3A and 4D levels are overexpressed in patients with heart failure. Study protocol:
Hospitallized patients with new onset or previously diagnosed heart failure will be recruited to the study. Control group will include healthy people with no medical records or chronic treatment at the same age range. After signing an informed constent form, full medical history and blood samples will be collected. A second blood sample will be collected 8 weeks later, assuming the patient was discharged and not hospitalized since than. The blood samples will be analyzed by Bnai Zion Medical Center Immunology labs for the above semaphorins levels in the heart failure group and control group. Statistical analysis will then commence for possible correlatoion with different clinical parameters.
Detailed description
In few previous published studies, Semaphorins 3A levels are overexpressed in patients with heart failure. The aim of our study is the compare semaphorin 3A and 4D in patients with acute decompansated heart failure with healthy donors. Second aim is to compare semaphorin level in the same patients in time of hospitalization and few weeks later when the heart failure presumingly controled. Statistical analysis will then commense for possible correlatoion with different clinical parameters like NYHA (new york heart association) status of the patient, lenghts of hospitalization and BNP (brain natriuretic peptide) levels at time of admition.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HF | – | Other: Biospecimen retentionHeart failure patients |
| Controls | – | Other: Biospecimen retentionHealthy donors |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with new onset or previously diagnosed heart failure
Key inclusion criteria (2 listed)
- Patients with new onset or previously diagnosed heart failure.
- Heart failure diagnosis can be based on clinical judgment, echocardiography or elevated BNP levels
Key exclusion criteria (1 listed)
- Patients with acute myocardial infarction diagnosed clinicly and labratory
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 |
|---|---|---|
| Biospecimen retention | Other | Controls, HF |
Primary outcome
Semaphrone 3A and 4D levels
Time frame: one year
1 secondary outcome
BNP level
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2015.
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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.
Zahava Vadas, MD. PHD. principal investigator
Bnai Zion Medical Center, Immunology devision
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Bnai Zion Medical Center.
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 2 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: status not confirmed, as of the sponsor's last update on 2 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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 Nadav Willner, MD. (9720543249856, nadav.willner@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Semaphrone 3A and 4D levels (time frame: one year). 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 2 Apr 2015.