Differential Gene Expression in Patients With Heart Failure and Iron Deficiency - Effects of Ferric Carboxymaltose

The primary efficacy objective of this study is to evaluate the effect of ferric carboxymaltose on mitochondrial gene activation pattern after 12 weeks of treatment.

Study Overview

• Status: Terminated
• Conditions: Heart Failure
• Intervention / Treatment: Drug: placebo; Drug: ferric carboxymaltose

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• Switzerland
  • ZH
    • Zurich, ZH, Switzerland, 8091
      • University Hospital Zurich, Division of Cardiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with chronic heart failure of New York Heart Association Class II or III, a left ventricular ejection fraction of ≤ 40% for patients in NYHA class II or ≤ 45% for patients in NYHA class III, a hemoglobin level at the screening visit between 9.5-13.5 g/dl, and iron deficiency, which is defined as serum ferritin level < 100µg/l or between 100 and 299 µg/l, when transferring saturation is < 20%.
• Age ≥18 years
• Obtained informed consent
• Stable pharmacological therapy during the last 4 weeks (with the exception of diuretics)

Exclusion Criteria:

• Hemochromatosis, iron overload, defined as TSAT > 45%
• Known hypersensitivity to Ferinject®.
• Known active infection, CRP>20 mg/L, clinically significant bleeding, active malignancy.
• Chronic liver disease and/or screening alanine transaminase (ALT) or aspartate transaminase (AST) above three times the upper limit of the normal range.
• Immunosuppressive therapy or renal dialysis (current or planned within the next 6 months).
• History of erythropoietin, i. v. or oral iron therapy, and blood transfusion in previous 12 weeks and/or such therapy planned within the next 6 months.
• Unstable angina pectoris as judged by the investigator, clinically significant uncorrected valvular disease or left ventricular outflow obstruction, obstructive cardiomyopathy, poorly controlled fast atrial fibrillation or flutter, poorly controlled symptomatic brady- or tachyarrhythmias.
• Acute myocardial infarction or acute coronary syndrome, transient ischemic attack or stroke within the last 3 months.
• Coronary-artery bypass graft, percutaneous intervention (e.g. cardiac, cerebrovascular, aortic; diagnostic catheters are allowed) or major surgery, including thoracic and cardiac surgery, within the last 3 months.
• Participation in a CHF training program.
• Known HIV/AIDS.
• Inability to fully comprehend and/or perform study procedures in the investigator's opinion.
• Vitamin B12 and/or serum folate deficiency according to the laboratory (re-screening is possible after substitution therapy).
• Pregnancy or lactation.
• Participation in another clinical trial within previous 30 days and/or anticipated participation in another trial during this study.
• Anticoagulation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: placebo
Active Comparator: ferric carboxymaltose	Drug: ferric carboxymaltose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary efficacy objective of this study is to evaluate the effect of ferric carboxymaltose on mitochondrial gene activation pattern after 12 weeks of treatment	The primary efficacy objective of this study is to evaluate the effect of ferric carboxymaltose on mitochondrial gene activation pattern after 12 weeks of treatment	12 weeks

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Frank Enseleit, MD, University Hospital Zurich, Devision of Cardiology

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: October 31, 2013
• First Submitted That Met QC Criteria: October 31, 2013
• First Posted (Estimate): November 7, 2013

Study Record Updates

• Last Update Posted (Actual): October 31, 2018
• Last Update Submitted That Met QC Criteria: October 29, 2018
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: heart failure
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: Vifor-HF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO