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

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ClinicalTrials.gov Identifier: NCT00384657
Recruitment Status : Withdrawn (Lack of cooperation among centers, Financial reasons)
First Posted : October 6, 2006
Last Update Posted : December 22, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Chronic Heart Failure Anemia Drug: iron sucrose Phase 3

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : January 2008
Primary Completion Date : December 2017
Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. percentage of patients with increased ejection fraction [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. the need for blood transfusions during the study period [ Time Frame: 12 months ]
  2. serum ferritin level [ Time Frame: 12 months ]
  3. transferrin saturation [ Time Frame: 12 months ]
  4. radial myocardial velocities [ Time Frame: 12 months ]
  5. right ventricular function [ Time Frame: 12 months ]
  6. global diastolic function [ Time Frame: 12 months ]
  7. left ventricular mass index [ Time Frame: 12 months ]
  8. major cardiovascular events (myocardial infarction, acute pulmonary edema, stroke) [ Time Frame: 12 months ]
  9. hospital admissions [ Time Frame: 12 months ]
  10. death of the patient (all causes deaths, cardiac deaths) [ Time Frame: 12 months ]
  11. slope of GFR change [ Time Frame: 12 months ]
  12. "death" of the kidney (initiation of renal replacement therapy) [ Time Frame: 12 months ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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): NCT00384657


Locations
Romania
"Dr Carol Davila" Teaching Hospital of Nephrology
Bucharest, Romania, 010731
"Caritas" Teaching Hospital, Cardiology Department
Bucharest, Romania
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

Responsible Party: Liliana Garneata, Dr, Anemia Working Group Romania
ClinicalTrials.gov Identifier: NCT00384657     History of Changes
Other Study ID Numbers: AWG_06_01
First Posted: October 6, 2006    Key Record Dates
Last Update Posted: December 22, 2017
Last Verified: December 2017

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

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