Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 6 of 380 for:    FERRIC CATION

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01978028
Recruitment Status : Terminated (Slow recruitment)
First Posted : November 7, 2013
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
University of Zurich

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.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: ferric carboxymaltose Drug: placebo Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Differential Gene Expression in Patients With Heart Failure and Iron Deficiency - Effects of Ferric Carboxymaltose
Study Start Date : October 2013
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: ferric carboxymaltose
ferric carboxymaltose
Drug: ferric carboxymaltose
Placebo Comparator: placebo
placebo
Drug: placebo



Primary Outcome Measures :
  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 [ Time Frame: 12 weeks ]
    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



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01978028


Locations
Layout table for location information
Switzerland
University Hospital Zurich, Division of Cardiology
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Layout table for investigator information
Principal Investigator: Frank Enseleit, MD University Hospital Zurich, Devision of Cardiology

Layout table for additonal information
Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01978028     History of Changes
Other Study ID Numbers: Vifor-HF
First Posted: November 7, 2013    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Zurich:
heart failure
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases
Ferric Compounds
Hematinics