Improving symptoms and exercise responses in patients heart failure with iron deficiency
- Conditions
- Chronic heart failureCirculatory SystemHeart failure
- Registration Number
- ISRCTN18444221
- Lead Sponsor
- niversity of Bristol
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- All
- Target Recruitment
- 48
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)
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method