Skip to content

Improving symptoms and exercise responses in patients heart failure with iron deficiency

Novel mechanisms of autonomic dysfunction in chronic heart failure – effects of iron replacement therapy on skeletal muscle metaboreflex and contribution to sympathetic nerve activation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN18444221
Enrollment
48
Registered
2020-02-28
Start date
2019-09-13
Completion date
Unknown
Last updated
2020-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic heart failure Circulatory System Heart failure

Interventions

Two groups of participants will be recruited: 1. Participants with chronic heart failure and an ejection fraction of less than 40% who are iron deficient as defined by the European Soc

Sponsors

University of Bristol
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Adults aged 18 and over 2. Diagnosis of chronic heart failure with reduced ejection fraction (HFrEF) 3. New York Heart Association (NYHA) class II and III symptoms 4. Able to attend for assessments 5. On stable, optimal treatment for heart failure. This includes stable pharmacological therapy and device therapy 6. Willingness to receive intravenous iron replacement therapy (if indicated)

Exclusion criteria

Exclusion criteria: 1. Unable to provide informed consent 2. Inability to participate in physical assessments for reasons other than HFrEF (e.g. musculoskeletal impairment, neurological disorder) 3. Severe COPD 4. Long term oxygen therapy 5. Uninvestigated anaemia 6. Active malignancy 7. Active bleeding source 8. Awaiting gastrointestinal investigations 9. Diagnosis of additional disease likely to significantly worsen over the following 12 months 10. Patients with diagnosis of heart failure with preserved ejection fraction or isolated right ventricular impairment 11. Previous allergic reaction to any intravenous iron preparation 12. NHYA class I and IV heart failure 13. Atrial fibrillation or frequent ectopy 14. Presence of cardiac device (pacemaker, implantable cardiac device, cardiac resynchronisation therapy) with frequent need for atrial pacing 15. Anticipated changes in heart failure treatment over the next 3 months 16. Taking immunosuppressive therapy 17. Known autoimmune or inflammatory disorders 18. Diagnosis of ongoing primary muscle or neurological disorder

Design outcomes

Primary

MeasureTime frame
Muscle sympathetic nerve activity assessed by microneurography before and after treatment with intravenous iron therapy

Secondary

MeasureTime frame
1. Levels of activity of the autonomic nervous system assessed by measured activity of physical observations such as heart rate, blood pressure, respiratory rate and cardiopulmonary function testing post exercise before and after treatment with intravenous iron therapy 2. Blood markers of inflammation before and after treatment with intravenous iron therapy

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026