Heart FailurePhase 4NCT03042130
Treatment With IV Iron in Hospitalized Patients With Severe Heart Failure But Without Iron Deficiency
A Phase 4 study testing Iron Carboxymaltose in people with Heart Failure, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Patients with congestive heart failure, grade 3-4, in addition to the standard care, will be randomized 1:1. The study group will receive 2 doses of IV iron (Iron carboxymaltose). The control group will receive standard of care alone. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Iron Carboxymaltose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- 14 Dec 2016to 6 Feb 2018
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Heart failure grade 3-4
- Heart echo EF< 40% (ejection fraction)
- Hb > 10 mg/dL
- Iron> 50 mic/dL
- Iron/ transferrin rate > 20%
Who cannot join
- Infection
- Acute ischemia
- Patients that didn't receive the standard of care during 3 days before investigational product administration
- Hemochromatosis
- Known allergy to one of the products of the investigational product.
- Macrocytic anemia
Show all 9Show fewer
- Iron excess
- Pregnant women
- Mentally disabled patients which can't give their concent properly.
Trial locations and contacts
1 site in 1 country.
About this study
Patients with congestive heart failure, grade 3-4, in addition to the standard care, will be randomized 1:1. The study group will receive 2 doses of IV iron (Iron carboxymaltose). The control group will receive standard of care alone. The study will test for the effects of the additional IV iron on the symptoms, clinical picture and quality of life of the treated patients.
Read the detailed description
Patients with congestive heart failure, grade 3-4, in addition to the standard care, will be randomized 1:1. The study group will receive 2 doses of IV iron (Iron carboxymaltose). The control group will receive standard of care alone. The study will test for the effects of the additional IV iron on the symptoms, clinical picture and quality of life of the treated patients. The parameters that will be measured will include clinical, lab, echo, and quality of life questionnaires.
- Conditions
- Heart Failure
- Being tested
- Standard of care, Iron Carboxymaltose
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of careOther
standard of care
Iron CarboxymaltoseDrug
Also called Ferinject
Two IV doses
| Study group | Role | What they receive |
|---|---|---|
| Iron Carboxymaltose | Experimental | standard of care + double dose of IV iron ferinject
the medicine will be given twice within one week. Receives: Other: Standard of care; Drug: Iron Carboxymaltose |
| control | Other | standard of care Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functioning improvement
NYHA assesment (New York Heart Association (NYHA) Functional Classification)
Measured: 5 days after second administration
Quality of life improvement
KCCQ questionnaires
Measured: 5 days after second administration
Functioning improvement
NYHA assesment (New York Heart Association (NYHA) Functional Classification)
Measured: 1 month after second administration
Quality of life improvement
KCCQ (The Kansas City Cardiomyopathy Questionnaire)
Measured: 1 month after second administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start14 Dec 2016
- Primary completion6 Feb 2018
- Study completion6 Feb 2018
Why it stopped: no recruitment
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.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Howard Oster, Dr., Principal investigator, Physician - Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03042130
- Sponsor's protocol ID
- TASMC-16-HO-512-CTIL
- Status last verified
- Feb 2018
- First submitted
- 17 Jan 2017
- Last updated
- 28 Feb 2018
- 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 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment With IV Iron in Hospitalized Patients With Severe Heart Failure But Without Iron Deficiency
- ClinicalTrials.gov ID
- NCT03042130
- Acronym / sponsor ID
- TASMC-16-HO-512-CTIL
- Conditions
- Heart Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 14 Dec 2016 (actual)
- Primary completion
- 6 Feb 2018 (actual)
- Study completion
- 6 Feb 2018 (actual)
- First posted
- 3 Feb 2017 (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.
Patients with congestive heart failure, grade 3-4, in addition to the standard care, will be randomized 1:1. The study group will receive 2 doses of IV iron (Iron carboxymaltose). The control group will receive standard of care alone. The study will test for the effects of the additional IV iron on the symptoms, clinical picture and quality of life of the treated patients.
Detailed description
Patients with congestive heart failure, grade 3-4, in addition to the standard care, will be randomized 1:1. The study group will receive 2 doses of IV iron (Iron carboxymaltose). The control group will receive standard of care alone. The study will test for the effects of the additional IV iron on the symptoms, clinical picture and quality of life of the treated patients. The parameters that will be measured will include clinical, lab, echo, and quality of life questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iron Carboxymaltose | Experimental | Other: Standard of care, Drug: Iron Carboxymaltosestandard of care + double dose of IV iron ferinject the medicine will be given twice within one week. |
| control | Other | Other: Standard of carestandard of care |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Heart failure grade 3-4
- Heart echo EF< 40% (ejection fraction)
- Hb > 10 mg/dL
- Iron> 50 mic/dL
- Iron/ transferrin rate > 20%
Key exclusion criteria (9 listed)
- Infection
- Acute ischemia
- Patients that didn't receive the standard of care during 3 days before investigational product administration
- Hemochromatosis
- Known allergy to one of the products of the investigational product.
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 |
|---|---|---|
| Standard of carestandard of care | Other | Iron Carboxymaltose, control |
| Iron CarboxymaltoseAlso: FerinjectTwo IV doses | Drug | Iron Carboxymaltose |
Primary outcome
Functioning improvement
Time frame: 5 days after second administration
NYHA assesment (New York Heart Association (NYHA) Functional Classification)
Quality of life improvement
Time frame: 5 days after second administration
KCCQ questionnaires
Functioning improvement
Time frame: 1 month after second administration
NYHA assesment (New York Heart Association (NYHA) Functional Classification)
Quality of life improvement
Time frame: 1 month after second administration
KCCQ (The Kansas City Cardiomyopathy Questionnaire)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
Howard Oster, Dr. principal investigator
Physician - Internal Medicine
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 Iron Carboxymaltose in people with Heart Failure, run by Tel-Aviv Sourasky 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 9 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: withdrawn, as of the sponsor's last update on 28 Feb 2018. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Functioning improvement (time frame: 5 days after second administration). The study lists 4 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 28 Feb 2018.