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

NCT01978028 | Terminated Phase 4

• 1 other identifier: Vifor-HF
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure

Keywords

heart failure

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

ferric carboxymaltose

ACTIVE COMPARATOR

ferric carboxymaltose

Drug: ferric carboxymaltose

placebo

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

ferric carboxymaltose DRUG

ferric carboxymaltose

placebo DRUG

placebo

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich, Division of Cardiology

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Heart Failure

Interventions

ferric carboxymaltose

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Frank Enseleit, MD

  University Hospital Zurich, Devision of Cardiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2013
• First Posted: November 7, 2013
• Study Start: October 1, 2013
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: October 31, 2018

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)