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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Anemia Working Group Romania
Sponsor:
Information provided by (Responsible Party):
Liliana Garneata, Anemia Working Group Romania
ClinicalTrials.gov Identifier:
NCT00384657
First received: October 5, 2006
Last updated: January 29, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Chronic Kidney Disease
Chronic Heart Failure
Anemia
Drug: iron sucrose
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effects of Intravenous Iron Therapy for Anemia Correction in Patients With Severe Chronic Heart Failure and Concomitant Moderate Chronic Kidney Disease

Resource links provided by NLM:


Further study details as provided by Anemia Working Group Romania:

Primary Outcome Measures:
  • percentage of patients with increased ejection fraction [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the need for blood transfusions during the study period [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • serum ferritin level [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • transferrin saturation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • radial myocardial velocities [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • right ventricular function [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • global diastolic function [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • left ventricular mass index [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • major cardiovascular events (myocardial infarction, acute pulmonary edema, stroke) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • hospital admissions [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • death of the patient (all causes deaths, cardiac deaths) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • slope of GFR change [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • "death" of the kidney (initiation of renal replacement therapy) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: January 2008
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group I
iv iron sucrose
Drug: iron sucrose

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.

Other Names:
  • Group I - iv iron group
  • Group II - conventional treatment group
No Intervention: Group II
Patients will receive conventional treatment of Chronic Heart Failure.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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%)

Exclusion Criteria:

  • 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
  • iron therapy in the preceding three months
  • concomitant erythropoietin therapy
  • severe arterial hypertension (systolic BP >190 mm Hg and/or diastolic BP >115 mm Hg)
  • recent history (less than 3 months) of acute coronary syndrome
  • recent (less than 1 month) PCI
  • recent (less than 1 month) CABG surgery
  • active myocarditis
  • active endocarditis
  • more than mild valvar stenosis
  • more than moderate valvar (mitral or aortic) regurgitation
  • uncontrolled haemodynamically relevant atrial fibrillation/flutter
  • hypertrophic cardiomyopathy
  • acute and/or chronic pericarditis
  • cor pulmonale
  • participation in another study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00384657

Contacts
Contact: Gabriel Mircescu, Professor +40 722 214504 lilianagarna@yahoo.com
Contact: Liliana Garneata, MD, PhD lilianagarna@yahoo.com

Locations
Romania
"Caritas" Teaching Hospital, Cardiology Department Recruiting
Bucharest, Romania
Contact: Ondin Zaharia, MD, PhD       ondin@hotmail.com   
Principal Investigator: Tiberiu Nanea, Professor         
Sub-Investigator: Ondin Zaharia, MD, PhD         
"Dr Carol Davila" Teaching Hospital of Nephrology Recruiting
Bucharest, Romania, 010731
Contact: Liliana Garneata, Md, PhD    +40722619358    lilianagarna@yahoo.com   
Sub-Investigator: Ligia Petrescu, MD, PhD         
Sub-Investigator: Simona Hildegard Stancu, MD, PhD         
Sub-Investigator: Cristina Stela Capusa, MD, PhD         
Principal Investigator: Gabriel Mircescu, Professor         
Sub-Investigator: Liliana Garneata, MD, PhD         
Sponsors and Collaborators
Anemia Working Group Romania
Investigators
Study Director: Gabriel Mircescu, Professor Dr Carol Davila Teaching Hospital of Nephrology
Principal Investigator: Tiberiu Nanea, Professor "Caritas" Teaching Hospital, Bucharest
Principal Investigator: Liliana Garneata, MD, PhD Dr Carol Davila Teaching Hospital of Nephrology Bucharest
  More Information

No publications provided

Responsible Party: Liliana Garneata, Dr, Anemia Working Group Romania
ClinicalTrials.gov Identifier: NCT00384657     History of Changes
Other Study ID Numbers: AWG_06_01
Study First Received: October 5, 2006
Last Updated: January 29, 2013
Health Authority: Romania: National Medicines Agency

Keywords provided by Anemia Working Group Romania:
chronic heart failure
chronic kidney disease
anemia
intravenous iron

Additional relevant MeSH terms:
Anemia
Heart Failure
Kidney Diseases
Renal Insufficiency, Chronic
Cardiovascular Diseases
Heart Diseases
Hematologic Diseases
Renal Insufficiency
Urologic Diseases
Ferric oxide, saccharated
Iron
Growth Substances
Hematinics
Hematologic Agents
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Trace Elements

ClinicalTrials.gov processed this record on November 25, 2014