Effect of IV Iron in Patients With Heart Failure With Preserved Ejection Fraction

NCT03074591 | Completed Phase 4 DMC

• 1 other identifier: Charite
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Iron-deficiency; Heart Failure

Keywords

Iron deficiency; Heart failure

Outcome Measures

Primary Outcomes (1)

• exercise capacity

  The difference of 6-minute walking distance in meters from baseline to week 24 in symptomatic patients with HFpEF with documented ID compared to the control group.

  24 weeks

Secondary Outcomes (5)

• 6min-walking distance

  52 weeks

• Patient Global Assessment (PGA)

  52 weeks

• NYHA functional class

  52 weeks

• Change in quality of life assessments

  52 weeks

• Rate of recurrent heart failure hospitalisations and death

  52 weeks

Study Arms (2)

Treatment

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

Placebo: Normal saline (0.9% weight/volume (w/v) NaCl) administered in analogy to active treatment procedures.

Drug: Saline Solution for Injection

Interventions

Ferric Carboxymaltose 50Mg/Ml Inj 15Ml DRUG

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.

Also known as: Ferric Carboxymaltose

Treatment

Saline Solution for Injection DRUG

In the placebo/saline group, patients will receive the aequivalent number of normal saline infusions.

Also known as: Saline Solution

Placebo

Eligibility Criteria

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

You may qualify if:

• Patient is willing to participate and provides written informed consent;
• Age ≥18 years;
• 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);
• 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);
• Treated with a diuretic;
• Presence of atrial fibrillation (AF) at screening or randomisation is allowed in 2 out of 4 patients (calculated per centre);
• At screening or randomisation, presence of one of the following criteria:
• hospitalisation with a diagnosis of HF within 12 months prior to planned randomisation; OR
• 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)
• Evidence of diastolic dysfunction at screening or randomisation, defined as:
• E/E' \>13; OR
• LA width ≥38 mm; OR
• LA length ≥50 mm; OR
• LA area ≥20 cm2; OR
• LA volume ≥55 ml; OR

You may not qualify if:

• Unable to sign informed consent
• Any prior echocardiography measurement of LVEF \<40%;
• Clinical signs and symptoms of infection including fever \>38°C;
• Use of IV iron, erythropoietin or blood transfusions within the previous 60 days;
• Use of concurrent immunosuppressive therapy;
• History of acquired iron overload or haemochromatosis (or a first relative with haemochromatosis);
• Known hypersensitivity to FCM or any other IV iron product;
• Known bleeding or haemolytic anemia;
• 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;
• 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:
• Severe COPD, i.e. with known FEV1 \<50%, requiring home oxygen therapy, or on chronic oral steroid therapy;
• body mass index ≥40.0 kg/m2;
• Presence of uncontrolled atrial fibrillation with resting heart rate \>110/min;
• Presence of uncontrolled hypertension with blood pressure \>160/100 mm Hg;
• Renal replacement therapy;

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• University of Göttingen: collaborator

Study Sites (7)

Innere Medizin/Kardiologie

Nuremberg, Bavaria, 90402, Germany

Location

University Medical Center Göttingen

Göttingen, Lower Saxony, 37075, Germany

Location

Saarland University Medical Center

Homburg, Saarland, 66421, Germany

Location

Herzzentrum Dresden GmbH

Dresden, Saxony, 01307, Germany

Location

Charité University Medicine Berlin

Berlin, 13353, Germany

Location

Universitäres Herzzentrum Hamburg

Hamburg, 20095, Germany

Location

Herzklinik Ulm

Ulm, 89077, Germany

Location

Related Publications (1)

• von Haehling S, Doehner W, Evertz R, Garfias-Veitl T, Diek M, Karakas M, Birkemeyer R, Fillippatos G, Ponikowski P, Böhm M, Friede T, Anker SD. Iron deficiency in heart failure with preserved ejecton fracton: ratonale and design of the FAIR-HFpEF trial. Global Cardiol 2023; 1: 39-46.

  BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Heart Failure; Iron Deficiencies

Interventions

ferric carboxymaltose; Saline Solution; Injections

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Stefan Anker, Prof

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 1, 2017
• First Posted: March 9, 2017
• Study Start: August 1, 2017
• Primary Completion: December 13, 2022
• Study Completion: April 10, 2024
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: after publication of main results

Locations

DE (7)