Iron Supplementation in Heart Failure Patients With Anemia: The IRON-HF Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00386126|
Recruitment Status : Unknown
Verified August 2006 by Hospital de Clinicas de Porto Alegre.
Recruitment status was: Recruiting
First Posted : October 11, 2006
Last Update Posted : October 11, 2006
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure Anemia||Drug: Iron Sucrose IV 200mg, once a week, for 5 weeks Drug: Ferrous sulfate 200mg PO TID, for 8 weeks||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||117 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Randomized Trial to Assess the Effects of Iron Supplementation in Heart Failure Patients With Anemia: The IRON-HF Study|
|Study Start Date :||August 2006|
- 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.
- 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
- Incidence of adverse events (drug tolerance).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00386126
|Contact: Luis Beck-da-Silva, MD||55 51 21018657 ext email@example.com|
|Contact: Michelle C Assis, RN||55 51 21018657 ext firstname.lastname@example.org|
|Cardiovascular Division, Hospital de Clínicas de Porto Alegre||Recruiting|
|Porto Alegre, RS, Brazil, 90035-003|
|Contact: Luis Beck-da-Silva, MD 55 5121018344 ext 8344 email@example.com|
|Study Chair:||Nadine Clausell, MD||Hospital de Clínicas de Porto Alegre|