Effect of iron supplementation on symptoms of patient wit heart failure andiron deficiency.

Phase 1

Active, not recruiting

• Conditions: Patients with heart failure with preserved ejection fraction (HFpEF) and iron deficiency (ID) with and without anaemia; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-005757-12-DE
• Lead Sponsor: Charité – Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-02
• Last Update Posted: 15 January 2024

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 200

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:
a)hospitalisation with a diagnosis of HF within 12 months prior to planned randomisation; OR
b)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:
a)E/E’ >13; OR
b)LA width =38 mm; OR
c)LA length =50 mm; OR
d)LA area =20 cm2; OR
e)LA volume =55 ml; OR
f) 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).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

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. SARS-CoV-2 infection
5. Use of IV iron, erythropoietin or blood transfusions within the previous 60 days;
6. Use of concurrent immunosuppressive therapy;
7. History of acquired iron overload or haemochromatosis (or a first relative with
haemochromatosis);
8. Known hypersensitivity to FCM or any other IV iron product;
9. Known bleeding or haemolytic anemia;
10. 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 bradyarrhythmias
or tachy-arrhythmias;
11. Probable alternative diagnoses that in the opinion 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:
a) Severe COPD, i.e. with known FEV1 <50%, requiring home oxygen therapy, or on
chronic oral steroid therapy;
b) body mass index =40.0 kg/m2;
12. Presence of uncontrolled atrial fibrillation with resting heart rate >110/min;
13. Presence of uncontrolled hypertension with blood pressure >160/100 mm Hg;
14. Renal replacement therapy;
15. Concurrent therapy with an erythropoiesis stimulating agent;
16. Known active malignancy;
17. Known HIV or active hepatitis infection;
18. Pregnancy;
19. Patients, who may be dependent on the sponsor, the investigator or the trial sites, have
to exclude from the trial;
20. Lack of willingness to storage and disclosure of pseudonymous disease data in the
context of the clinical trial;
21. Participation in another clinical trial within previous 30 days and/or anticipated
participation in another trial during this study;
22. Inability to fully comprehend and/or perform study procedures in the investigator’s
opinion;
23. Persons staying at an institution due to order by a national body or a court of law (in
accordance with the German Arzneimittelgesetz §40, Abs. 1, S. 3, Nr. 4);

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified