Effect of IV Iron in Patients With Heart Failure With Preserved Ejection Fraction (FAIR-HFpEF)

March 5, 2020 updated by: Doehner, W, Charite University, Berlin, Germany

Effect of IV Iron (Ferric Carboxymaltose, Ferinject) on Exercise Tolerance, Symptoms and Quality of Life in Patients With Heart Failure With Preserved Ejection Fraction (HFpEF) and Iron Deficiency With and Without Anaemia.

This study addresses, whether treatment with IV iron for patients with heart failure with preserved ejection fraction (HFpEF) and iron deficiency (ID), both with or without anaemia, can improve exercise capacity as measured by 6-minute walking test (6-MWT) and symptoms while being safe

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

All previous trials have excluded patients with HFpEF. This study addresses, whether treatment with IV iron for patients with heart failure with preserved ejection fraction (HFpEF) and iron deficiency (ID), both with or without anaemia, can improve exercise capacity as measured by 6-minute walking test (6-MWT) and symptoms while being safe. The FAIR-HFpEF study was designed to evaluate the efficacy of Ferinject® in improving symptoms of HFpEF in patients with ID. Analyses will focus both on subjective and objective measures as well as on patients with and without anaemia. Furthermore, the tolerability and safety of Ferinject® treatment will be evaluated.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  1. Patient is willing to participate and provides written informed consent;
  2. Age ≥18 years;
  3. Clinical diagnosis of heart failure with preserved ejection fraction (HFpEF) with LVEF ≥45% at screening or within 6 months prior to planned randomisation (assessed by echocardiography or MRI);
  4. Ambulatory for at least 7 days with NYHA class II or III at time of randomisation (the screening visit can take place at the end of a hospitalisation);
  5. Treated with a diuretic;
  6. Presence of atrial fibrillation (AF) at screening or randomisation is allowed in 2 out of 4 patients (calculated per centre);

  7. At screening or randomisation, presence of one of the following criteria:

    1. hospitalisation with a diagnosis of HF within 12 months prior to planned randomisation; OR
    2. raised plasma levels of natriuretic peptides in a patient with sinus rhythm (i.e. in patients without AF: NT-proBNP >300 pg/mL or BNP >100 pg/mL or MR-proANP >120 pmol/L; in patients with AF: NT-proBNP >600 pg/mL or BNP >200 pg/mL or MR-proANP >250 pmol/l)

  8. Evidence of diastolic dysfunction at screening or randomisation, defined as:

    1. E/E' >13; OR
    2. LA width ≥38 mm; OR
    3. LA length ≥50 mm; OR
    4. LA area ≥20 cm2; OR
    5. LA volume ≥55 ml; OR
    6. left atrial volume index >28 mL/m2;
  9. Haemoglobin >9.0 g/dL and ≤14.0 g/dL (at screening);
  10. ID with ferritin <100 ng/mL or ferritin 100-299 plus TSAT <20% (at screening);
  11. 6-minute-walking distance at baseline <450 m (average of the last 2 documented tests within 8 weeks prior to planned randomisation that also need to be within 20% of each other).

Exclusion Criteria:

  1. Unable to sign informed consent
  2. Any prior echocardiography measurement of LVEF <40%;
  3. Clinical signs and symptoms of infection including fever >38°C;
  4. Use of IV iron, erythropoietin or blood transfusions within the previous 60 days;
  5. Use of concurrent immunosuppressive therapy;
  6. History of acquired iron overload or haemochromatosis (or a first relative with haemochromatosis);
  7. Known hypersensitivity to FCM or any other IV iron product;
  8. Known bleeding or haemolytic anemia;
  9. Presence of any condition that precludes exercise testing, such as decompensated HF, significant musculoskeletal disease, unstable angina pectoris, obstructive cardiomyopathy, severe uncorrected valvular disease, or uncontrolled brady-arrhythmias or tachy-arrhythmias;

  10. Probable alternative diagnoses that in the opiniton of the investigator could account for the patient's HF symptoms such as severe obesity, primary pulmonary hypertension, or chronic obstructive pulmonary disease (COPD); hence, patients with the following are excluded:

    1. Severe COPD, i.e. with known FEV1 <50%, requiring home oxygen therapy, or on chronic oral steroid therapy;
    2. body mass index ≥40.0 kg/m2;
  11. Presence of uncontrolled atrial fibrillation with resting heart rate >110/min;
  12. Presence of uncontrolled hypertension with blood pressure >160/100 mm Hg;
  13. Renal replacement therapy;
  14. Concurrent therapy with an erythropoiesis stimulating agent;
  15. Known active malignancy;
  16. Known HIV or active hepatitis infection;
  17. Pregnancy;
  18. Patients, who may be dependent on the sponsor, the investigator or the trial sites, have to be excluded from the trial
  19. Lack of willingness to storage and disclosure of pseudonymous disease data in the context of the clinical trial.
  20. Participation in another clinical trial within previous 30 days and/ or anticipated participation in another trial during this study.
  21. Inability to fully comprehend and/or perform study procedures in the investigator's opinion;
  22. Persons staying at an institution due to order by a national body or a court of law.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment
Active treatment: Ferric Carboxymaltose solution (Ferinject®) for parenteral application, 50 mg/mL iron. Medication will be given as a short time infusion over 15 minutes in 100mL NaCl.
Drug: Ferric Carboxymaltose 50Mg/Ml Inj 15Ml
After baseline assessments patients will be randomised in a 1:1 ratio to receive Ferric Carboxymaltose IV or placebo/saline (normal saline: 0.9% w/v NaCl). In the Treatment group, Ferric Carboxymaltose will be administered according to the dosing schedule.
Other Names:
  • Ferric Carboxymaltose
Placebo Comparator: Placebo
Placebo: Normal saline (0.9% weight/volume (w/v) NaCl) administered in analogy to active treatment procedures.
Drug: Saline Solution for Injection
In the placebo/saline group, patients will receive the aequivalent number of normal saline infusions.
Other Names:
  • Saline Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
exercise capacity
Time Frame: 52 weeks
The difference of 6-minute walking distance in meters from baseline to end of study in symptomatic patients with HFpEF with documented ID compared to the control group.
52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6min-walking distance
Time Frame: 52 weeks
Difference of 6-minute walking distance in meters from baseline end of study in symptomatic patients with HFpEF with documented ID compared to the control group
52 weeks
PGA quality of life questionaire
Time Frame: 52 weeks
Difference in quality of life in symptomatic patients with HFpEF with documented ID from baseline to end of study.
52 weeks
NYHA functional class
Time Frame: 52 weeks
Difference in NYHA class from baseline to end of study in symptomatic patients with HFpEF
52 weeks
Mortality and Heart failure-related hospitalization rates
Time Frame: 52 weeks
Effects on mortality and HF-related hospitalization rates in symptomatic patients from baseline to end of study.
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

University of Göttingen

Investigators

  • Principal Investigator: Wolfram Doehner, Prof, Charite University, Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Anticipated)

July 1, 2020

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

March 1, 2017

First Submitted That Met QC Criteria

March 3, 2017

First Posted (Actual)

March 9, 2017

Study Record Updates

Last Update Posted (Actual)

March 6, 2020

Last Update Submitted That Met QC Criteria

March 5, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Charite

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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