NCT02392910

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2006

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

March 15, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 19, 2015

Completed
Last Updated

March 19, 2015

Status Verified

March 1, 2015

Enrollment Period

5.9 years

First QC Date

March 15, 2015

Last Update Submit

March 18, 2015

Conditions

Iron DeficiencyHeart FailureChronic Kidney Disease

Keywords

Iron SucroseMortalityHospitalization

Outcome Measures

Primary Outcomes (1)

  • mortality

    5 years

Secondary Outcomes (1)

  • Hospitalization

    5 years

Study Arms (2)

Group A

OTHER

Placebo

Drug: Placebo

Group B

OTHER

Iron Sucrose

Drug: Iron Sucrose

Interventions

Iron SucroseDRUG

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.

Also known as: Venofer
Group B
PlaceboDRUG

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.

Also known as: Sodium Chloride 0.9%
Group A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Aleman

Buenos Aires, Buenos Aires F.D., 1118, Argentina

Location

Related Publications (1)

  • Toblli JE, Lombrana A, Duarte P, Di Gennaro F. Intravenous iron reduces NT-pro-brain natriuretic peptide in anemic patients with chronic heart failure and renal insufficiency. J Am Coll Cardiol. 2007 Oct 23;50(17):1657-65. doi: 10.1016/j.jacc.2007.07.029.

    PMID: 17950147BACKGROUND

MeSH Terms

Conditions

Iron DeficienciesHeart FailureRenal Insufficiency, Chronic

Interventions

Ferric Oxide, SaccharatedSodium Chloride

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHeart DiseasesCardiovascular DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ferric CompoundsIron CompoundsInorganic ChemicalsGlucaric AcidSugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydratesChloridesHydrochloric AcidChlorine CompoundsSodium Compounds

Study Officials

  • Jorge E Toblli, MD; PhD

    Hospital Aleman

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Jorge Eduardo Toblli, MD; PhD; FASN. Professor of Medicine. Chief of Nephrology.

Study Record Dates

First Submitted

March 15, 2015

First Posted

March 19, 2015

Study Start

March 1, 2006

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

March 19, 2015

Record last verified: 2015-03

Locations

AR(1)