Intravenous Iron in Patients With Severe Chronic Heart Failure and Chronic Kidney Disease

NCT00384657 | Withdrawn Phase 3

• 1 other identifier: AWG_06_01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

Recently, growing body of evidence support the finding that anemia frequently occurs in patients with chronic heart failure (CHF). Chronic kidney disease (CKD), as well, is highly prevalent among heart failure patients, and both anemia and CKD are independently associated with increased mortality. A vicious circle is established with CHF causing both chronic renal insufficiency and anemia, and CKD further aggravating anemia which, in turn, worsens CHF and so on. Treatment of the anemia breaks this circle and improves the quality of life, cardiac and renal functions in patients with severe CHF. Intravenous iron alone was proved to allow the maintenance of target hematocrit in one-third of chronic renal failure predialysis patients. Based on these considerations, intravenous iron for anemia in patients with CHF and moderate CKD would represent a reasonable therapeutic approach. The aim of the trial is to assess the efficiency of intravenous iron therapy in the management of mild to moderate anemia associated with CHF NYHA III class and concomitant moderate CKD.

Conditions

Chronic Kidney Disease; Chronic Heart Failure; Anemia

Keywords

chronic heart failure; chronic kidney disease; anemia; intravenous iron

Outcome Measures

Primary Outcomes (1)

• percentage of patients with increased ejection fraction

  12 months

Secondary Outcomes (12)

• the need for blood transfusions during the study period

  12 months

• serum ferritin level

  12 months

• transferrin saturation

  12 months

• radial myocardial velocities

  12 months

• right ventricular function

  12 months

Study Arms (2)

Group I

EXPERIMENTAL

iv iron sucrose

Drug: iron sucrose

Group II

NO INTERVENTION

Patients will receive conventional treatment of Chronic Heart Failure.

Interventions

iron sucrose DRUG

Patients in Group I will receive iv iron sucrose, as described in the study protocol. Patient in Group II will receive conventional treatment for chronic heart failure.

Also known as: Group I - iv iron group, Group II - conventional treatment group

Group I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• persistent severe CHF: functional class NYHA III (marked limitation of physical activity - comfortable at rest, but less than ordinary activity results in shortness of breath and/or fatigue16); left ventricular ejection fraction (echocardiography) less than 40%; functional and systolic dysfunction criteria must be stable at two different examinations one month apart;
• stable stage 3 chronic kidney disease: estimated GFR between 30-59mL/min/1.73m2 (mean value of three measurements within the last 8 weeks, separated from each other by at least one week); stable renal function (at least three different measurements within the past 8 weeks, separated from each other by at least one week; the difference between the highest and the lowest value should be less than 5mL/min/1.73m2)
• mild to moderate anemia: hemoglobin levels \< 12g/dL (mean value of three measurements within the last 8 weeks, separated from each other by at least one week) and stable (at least three measurements within the last 8 weeks; the difference between the highest and the lowest value should be less than 1.5g/dL);
• iron deficiency: absolute (serum ferritin \< 100ng/mL) or functional (serum ferritin 100-300ng/mL and transferrin saturation \< 20%)

You may not qualify if:

• evidence of active gastrointestinal or genital tract bleeding
• folate or vitamin B12 deficiency
• hypothyroidism
• hemolytic anemia
• any primary kidney diseases (glomerulonephritis, interstitial nephritis, cystic diseases)
• systemic diseases with renal involvement (lupus erythematosus, vasculitis, amyloidosis)
• renal artery stenosis (\>70% lumen reduction)
• diabetic nephropathy
• severe malnutrition (SGA score C or lower)
• active liver diseases
• infectious conditions
• malignancies
• C-reactive protein \> 12 mg/L
• severe anemia (\< 8.5g/dL)
• blood transfusions in the preceding two months

Sponsors & Collaborators

• Anemia Working Group Romania: lead

Study Sites (2)

"Dr Carol Davila" Teaching Hospital of Nephrology

Bucharest, 010731, Romania

Location

"Caritas" Teaching Hospital, Cardiology Department

Bucharest, Romania

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Anemia

Interventions

Ferric Oxide, Saccharated

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Gabriel Mircescu, Professor

  Dr Carol Davila Teaching Hospital of Nephrology

  STUDY DIRECTOR

• Tiberiu Nanea, Professor

  "Caritas" Teaching Hospital, Bucharest

  PRINCIPAL INVESTIGATOR

• Liliana Garneata, MD, PhD

  Dr Carol Davila Teaching Hospital of Nephrology Bucharest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: October 5, 2006
• First Posted: October 6, 2006
• Study Start: January 1, 2008
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 22, 2017

Record last verified: 2017-12

Locations

RO (2)