Back to results

Iron Supplementation in Heart Failure Patients With Anemia: The IRON-HF Study

Primary Purpose

Heart Failure, Anemia

Status

Unknown status

Phase

Phase 2

Locations

Brazil

Study Type

Interventional

Intervention

Iron Sucrose IV 200mg, once a week, for 5 weeks

Ferrous sulfate 200mg PO TID, for 8 weeks

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Anemia, Treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18 years of age or older;
Outpatients followed at a HF Clinic in a tertiary care Hospital with clinical diagnosis of HF for at least 3 months before study entry;
NYHA functional class II to IV, who are able to perform ergospirometry;
Documentation of LVEF < 40% within the last 6 months;
Adequate baseline therapy for HF based on patient's functional class (β-blockers, ACE inhibitors irrespective of functional class except if contra-indications, digoxin, spironolactone if NYHA class III or IV);
Stable baseline HF therapy with same doses of medications and no intent to increase doses for the following 3 months;
Hemoglobin ≤ 12 g/dl and > 9 g/dl;
Transferrin saturation < 20% and ferritin < 500 µg/L;
Ability to provide written informed consent.

Exclusion Criteria:

Any clinically overt bleeding: gastrointestinal bleeding, hypermenorrhea, history of peptic ulcer without evidence of healing or inflammatory intestinal diseases;
Uncorrected hypothyroidism;
Other inflammatory, neoplastic or infectious disease;
Serum creatinine > 1,5 mg/dl;
Previous intolerance to oral elemental iron compounds;
HF due to alcoholic cardiomyopathy, current regular drinker of alcoholic beverages or HF due to peripartum cardiomyopathy;
Recent admission for decompensated HF (last month)
Recent myocardial revascularization procedures (last 3 months);
Recent ACS, stroke or TIA (last 3 months);
Active or metastatic neoplastic disease with life expectancy of less than a year;
Patients in heart transplantation list;
Patients that had participated in any other clinical trial or study within the last month;
Pregnant or lactating women;
Pre-menopausal women that are not using any effective method of contraception;
Patients using prohibited medications or that have not yet accomplished the wash-out period;
Patients currently participating in cardiovascular rehabilitation programs.

Sites / Locations

Cardiovascular Division, Hospital de Clínicas de Porto AlegreRecruiting

Outcomes

Primary Outcome Measures

The primary endpoint of the IRON-HF study is to assess the impact of iron supplementation alone (IV or PO) on changes in oxygen maximal consumption (peak VO2) assessed by ergospirometry over a 3-month follow-up period.

Secondary Outcome Measures

New York Heart Association (NYHA) functional class

BNP (B-type natriuretic peptide) levels

Quality of life using the Living with Heart Failure Minnesota Questionnaire

Left ventricular ejection fraction (LVEF) as assessed by the bi-planar modified Simpson method in two-dimensional echocardiography

Renal function as assessed by the serum levels of creatinine

Incidence of hospitalizations due to HF

Mortality

Incidence of adverse events (drug tolerance).

Full Information

NCT ID

NCT00386126

First Posted

October 6, 2006

Last Updated

October 6, 2006

Sponsor

Hospital de Clinicas de Porto Alegre

1. Study Identification

Unique Protocol Identification Number

NCT00386126

Brief Title

Iron Supplementation in Heart Failure Patients With Anemia: The IRON-HF Study

Official Title

Randomized Trial to Assess the Effects of Iron Supplementation in Heart Failure Patients With Anemia: The IRON-HF Study

Study Type

Interventional

2. Study Status

Record Verification Date

August 2006

Overall Recruitment Status

Unknown status

Study Start Date

August 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Hospital de Clinicas de Porto Alegre

4. Oversight

5. Study Description

Brief Summary

Anemia has been demonstrated to be a common finding in patients with heart failure (HF). Previous studies in hospitalized patients with HF have found a prevalence of anemia ranging from 15% to 63%. More importantly, anemic patients with HF have increased morbidity and mortality. The mechanisms underlying anemia in HF are multifactorial, involving mild to moderate forms of anemia of chronic disease and ferropenic anemia. The clinical impact of iron supplementation in HF patients who have a relatively preserved renal function and either chronic disease anemia, ferropenic anemia or both remains largely unknown. The route of iron administration that could be most clinically effective is also unclear. Thus, the primary aim of the IRON-HF study is to assess the effects of iron supplementation alone (IV or PO) on parameters of functional capacity in HF patients with anemia with decreased availability of iron.

Detailed Description

The IRON-HF study is an investigator initiated, multicenter, prospectively designed,randomized, double-blind, placebo controlled clinical trial. Randomization:Each of the eight participating centers will randomize patients by telephone contact with the randomization center at Hospital de Clínicas de Porto Alegre. The randomization system will be based on a computerized table of random numbers and performed in blocks of three per participating center. Blinding:Each participating center will elect a third party blind individual (usually a RN) who will open the allocated medication box, prepare iron sucrose infusions or saline and administer to patients in opaque devices. Both patient and attending physicians and/or nurses will be blind to allocated therapy. Oral medications and oral placebo will be identical in all aspects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure, Anemia

Keywords

Heart Failure, Anemia, Treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

117 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Iron Sucrose IV 200mg, once a week, for 5 weeks

Intervention Type

Drug

Intervention Name(s)

Ferrous sulfate 200mg PO TID, for 8 weeks

Primary Outcome Measure Information:

Title

Secondary Outcome Measure Information:

Title

New York Heart Association (NYHA) functional class

Title

BNP (B-type natriuretic peptide) levels

Title

Quality of life using the Living with Heart Failure Minnesota Questionnaire

Title

Left ventricular ejection fraction (LVEF) as assessed by the bi-planar modified Simpson method in two-dimensional echocardiography

Title

Renal function as assessed by the serum levels of creatinine

Title

Incidence of hospitalizations due to HF

Title

Mortality

Title

Incidence of adverse events (drug tolerance).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 years of age or older; Outpatients followed at a HF Clinic in a tertiary care Hospital with clinical diagnosis of HF for at least 3 months before study entry; NYHA functional class II to IV, who are able to perform ergospirometry; Documentation of LVEF < 40% within the last 6 months; Adequate baseline therapy for HF based on patient's functional class (β-blockers, ACE inhibitors irrespective of functional class except if contra-indications, digoxin, spironolactone if NYHA class III or IV); Stable baseline HF therapy with same doses of medications and no intent to increase doses for the following 3 months; Hemoglobin ≤ 12 g/dl and > 9 g/dl; Transferrin saturation < 20% and ferritin < 500 µg/L; Ability to provide written informed consent. Exclusion Criteria: Any clinically overt bleeding: gastrointestinal bleeding, hypermenorrhea, history of peptic ulcer without evidence of healing or inflammatory intestinal diseases; Uncorrected hypothyroidism; Other inflammatory, neoplastic or infectious disease; Serum creatinine > 1,5 mg/dl; Previous intolerance to oral elemental iron compounds; HF due to alcoholic cardiomyopathy, current regular drinker of alcoholic beverages or HF due to peripartum cardiomyopathy; Recent admission for decompensated HF (last month) Recent myocardial revascularization procedures (last 3 months); Recent ACS, stroke or TIA (last 3 months); Active or metastatic neoplastic disease with life expectancy of less than a year; Patients in heart transplantation list; Patients that had participated in any other clinical trial or study within the last month; Pregnant or lactating women; Pre-menopausal women that are not using any effective method of contraception; Patients using prohibited medications or that have not yet accomplished the wash-out period; Patients currently participating in cardiovascular rehabilitation programs.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Luis Beck-da-Silva, MD

Phone

55 51 21018657

Ext

8657

lbneto@hcpa.ufrgs.br

First Name & Middle Initial & Last Name or Official Title & Degree

Michelle C Assis, RN

Phone

55 51 21018657

Ext

8657

mcassis@hcpa.ufrgs.br

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nadine Clausell, MD

Organizational Affiliation

Hospital de Clínicas de Porto Alegre

Official's Role

Study Chair

Facility Information:

Facility Name

Cardiovascular Division, Hospital de Clínicas de Porto Alegre

City

Porto Alegre

State/Province

ZIP/Postal Code

90035-003

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Luis Beck-da-Silva, MD

Phone

55 5121018344

Ext

8344

lbneto@hcpa.ufrgs.br

12. IPD Sharing Statement

Citations:

PubMed Identifier

23680589

Citation

Beck-da-Silva L, Piardi D, Soder S, Rohde LE, Pereira-Barretto AC, de Albuquerque D, Bocchi E, Vilas-Boas F, Moura LZ, Montera MW, Rassi S, Clausell N. IRON-HF study: a randomized trial to assess the effects of iron in heart failure patients with anemia. Int J Cardiol. 2013 Oct 9;168(4):3439-42. doi: 10.1016/j.ijcard.2013.04.181. Epub 2013 May 13.

Results Reference

derived

Learn more about this trial

Iron Supplementation in Heart Failure Patients With Anemia: The IRON-HF Study

We'll reach out to this number within 24 hrs