Heart FailurePhase 4NCT00418119
Erythropoietin Treatment in Patients With Systolic Left Ventricular Dysfunction, Mild Anemia and Normal Renal Function
A Phase 4 study testing erythropoietin in people with Heart Failure, run by Rabin Medical Center at 1 site in Israel.
Trial summary
Erythropoietin Treatment in Patients with systolic left ventricular dysfunction, mild anemia and normal renal function 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?
- erythropoietin
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2007to Jan 2008
- Phase
- Phase 4
- 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
- Ischemic heart disease
- Systolic lv dysfunction
- Mild anemia
- Normal renal function
- Stable condition
Who cannot join
- Pregnancy
- Unstable condition
- Under 18 years old
Trial locations and contacts
1 site in 1 country.
Israel1 site
Cardiology Department, Rabin Medical Center
Petah Tikva, Petah Tikva, 49100
Tuvia Ben Gal, MD, 972-522757616, bengalt@clalit.org.il
Daniel Murninkas, MD, 972-39736930, murninkasd@clalit.org.il
About this study
Official title: Phase 4 Study on the Efficacy of Erythropoietin Treatment in Patients With Systolic Left Ventricular Dysfunction, Mild Anemia and Normal Renal Function
Erythropoietin Treatment in Patients with systolic left ventricular dysfunction, mild anemia and normal renal function
- Conditions
- Heart Failure
- Being tested
- erythropoietin
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erythropoietinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2007 (estimated)
- Study startJan 2007
- Study completionJan 2008
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Tuvia Ben Gal, MD, Principal investigator, Cardiology Department Rabin medical CenterOfer Shpilberg, Prof., Study director, Hematology Department Rabin Medical CenterDaniel Murninkas, MD, Study director, Cardiology Department Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00418119
- Sponsor's protocol ID
- 4273
- Status last verified
- Dec 2006
- First submitted
- 2 Jan 2007
- Last updated
- 4 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study on the Efficacy of Erythropoietin Treatment in Patients With Systolic Left Ventricular Dysfunction, Mild Anemia and Normal Renal Function
- ClinicalTrials.gov ID
- NCT00418119
- Acronym / sponsor ID
- 4273
- Conditions
- Heart Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Jan 2007
- Study completion
- Jan 2008
- First posted
- 4 Jan 2007 (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.
Erythropoietin Treatment in Patients with systolic left ventricular dysfunction, mild anemia and normal renal function
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ischemic heart disease
- Systolic lv dysfunction
- Mild anemia
- Normal renal function
- Stable condition
Key exclusion criteria (3 listed)
- Pregnancy
- Unstable condition
- Under 18 years old
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 |
|---|---|---|
| erythropoietin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2007.
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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.
Tuvia Ben Gal, MD principal investigator
Cardiology Department Rabin medical Center
Ofer Shpilberg, Prof. study director
Hematology Department Rabin Medical Center
Daniel Murninkas, MD study director
Cardiology Department Rabin 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 4 study testing erythropoietin in people with Heart Failure, run by Rabin 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 5 inclusion and 3 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 4 Jan 2007. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Tuvia Ben Gal, MD (972-522757616, bengalt@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 4 Jan 2007.