- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02392910
Hospitalization & Mortality in Patients With Iron Deficiency CKD and HF Treated With i.v. Iron.
March 18, 2015 updated by: Jorge Eduardo Toblli, Hospital Aleman
Hospitalization and Mortality in Iron Deficient, Anemic Patients With Chronic Kidney (CKD) and Heart Failure Receiving Intravenous Iron Therapy: A Five Year Follow-up From a Pilot Study
Iron deficiency, independent of anemia, appears to increase morbidity and mortality as well as impairing health-related quality of life in chronic heart failure (CHF), and these effects are compounded when patients also experience chronic kidney disease (CKD).
This study was designed to determine the effects of intravenous iron treatment on morbidity and mortality following an initial 6-month period and a longer period of up to 5 years.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Effect of i.v. iron sucrose on iron parameters and anemia
- During the original 6 month trial, patients in the i.v. iron group received 1000mg iron per the protocol. No patients required iron in the subsequent 6 months.
- During the subsequent follow-up, patients required a mean of between 165 and 274 mg iron per year (range: 0 to 600 mg per patient per year).
- Post the initial 1000mg iron, 19 out of 20 patients required at least a second dose of i.v. iron. Most patients required only one or two doses per year.
- The average time to requiring a second iron administration was 14.5 ± 2.7 months (range: 14 months, 23 months).
- Correction of iron deficiency (ID) resulted in statistically significant increases in transferrin saturation (TSAT) throughout the study (p < 0.01 untreated group). At all measured points, TSAT values in the treated group were at least on target (> 20% increase).
- For serum ferritin, significant differences were observed at 6 months and 1 year however this difference was not observed at 5 years post baseline where serum ferritin values were 173ng/mL and 167ng/mL for the control and IV iron groups, respectively.
- Statistically significant improvements versus the untreated group were observed for both hemoglobin (Hb) and creatinine clearance (CrCl) as well as for left ventricular ejection fraction (LVEF) and New York Heart Association (NYHA) functional class at each year.
Effect of i.v. iron sucrose on hospitalizations and mortality
- There were numerically fewer hospitalization reported at 6 months compared to those among untreated patients (0% and 25%, respectively), although the difference versus untreated patients was not statistically significant (p=ns).
- At 1 year after commencing the original study, the number of patients requiring a hospitalization (for any reason) was 50% in the control group and 10% in the IV iron group (p<0.01).
- By 5 years follow-up these rates had increased to 85% in the control arm and 20% in the IV iron treated group (p<0.01).
- In relation to all-cause mortality, there were no deaths in either group after the first 6 months. The number of deaths due to any cause after year 1 had increased in both groups (20% in the untreated group, 5% in the treated group; p=ns).
- At 5 years follow-up, 11 (55%) of patients in the control arm were deceased, compared with 4 (20%) in the IV iron treated group (p < 0.05).
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Caba
-
Buenos Aires, Caba, Argentina, 1118
- Hospital Aleman
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion:
- LV ejection fraction (EF) ≤ 35%
- New York Heart Association (NYHA) functional class II to IV
- Anemia with an iron deficit defined by Hb 12.5 g/dl for men and 11.5 g/dl for women, and some of the following: serum ferritin 100 ng/ml and/or with transferrin saturation (TSAT) 20%
- Creatinine clearance 90 ml/min.
Exclusion:
- Hemodialysis therapy
- Anemia not due to iron deficiency
- NYHA functional class I
- History of allergy to the iron supplements
- Acute bacterial infections, parasitism known in the 4 previous weeks
- Neoplasm
- Chronic digestive diseases
- Hypothyroidism
- Congenital cardiopathies
- Receiving iron supplements in the 4 previous weeks
- Receiving rhEPO in the 4 previous weeks
- History of hospitalization during the 4 weeks before enrollment into the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Group A
Placebo
|
At each visit, the patient lay on a stretcher and underwent a vein cannulation in the forearm with a commercial canula no.
16, which was connected to IV tubing that was connected to a bag of isotonic saline solution 0.9% (200 ml).
Each infusion was administered throughout 60 min.
This scheme was followed for 5 consecutive weeks.
Other Names:
|
Other: Group B
Iron Sucrose
|
At each visit, the patient lay on a stretcher and underwent a vein cannulation in the forearm with a commercial canula no.
16, which was connected to IV tubing that was connected to a bag contained 200 ml isotonic saline solution 0.9% plus 200 mg of Iron Sucrose.
Each infusion was administered throughout 60 min.
This scheme was followed for 5 consecutive weeks.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
mortality
Time Frame: 5 years
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hospitalization
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jorge E Toblli, MD; PhD, Hospital Aleman
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2006
Primary Completion (Actual)
February 1, 2012
Study Completion (Actual)
February 1, 2012
Study Registration Dates
First Submitted
March 15, 2015
First Submitted That Met QC Criteria
March 18, 2015
First Posted (Estimate)
March 19, 2015
Study Record Updates
Last Update Posted (Estimate)
March 19, 2015
Last Update Submitted That Met QC Criteria
March 18, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5427-06/07
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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