Trials / Withdrawn
WithdrawnNCT03803111
Effects of Iron Therapy and Exercise Training in Patients With Heart Failure and Iron Deficiency
A Randomized Trial on Sequential Effects of Iron Therapy and Exercise Training in Patients With Heart Failure and Iron Deficiency
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Herzzentrum Bremen · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
It is the aim of the study to prove, if intravenous supplementation with ferric carboxymaltose in iron-deficient patients with heart failure with reduced ejection fraction (HFrEF) leads to better exercise training effects compared to exercise training without previous iron supplementation.
Detailed description
In patients with heart failure with reduced ejection fraction (HFrEF) exercise training (ET) is recommended. In iron-deficient HFrEF patients iron supplementation by ferric carboxymaltose (FCM) is recommended. Both treatment options (ET and iron supplementation) affect oxidative metabolism. In this study iron-deficient HFrEF patients are included and randomly assigned to two study arms: Study arm A: Intravenous iron supplementation with FCM, subsequent (after 2 months) ET program. Study arm B: ET program, subsequent (after 2 months) intravenous iron supplementation with FCM. Primary study endpoint is exercise capacity (Peak VO2). Secondary endpoints are 6-minute walking distance, NYHA class, echocardiographic parameters and the combined endpoint cardiovascular hospitalizations and death.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Initial exercise training | Initial exercise training program |
| DRUG | Initial FCM | Initial intravenous iron supplementation (FCM) |
| DRUG | Subsequent FCM | Subsequent intravenous iron Supplementation (FCM) after 2 months |
| BEHAVIORAL | Subsequent exercise training | Subsequent exercise training program after 2 months |
Timeline
- Start date
- 2021-01-01
- Primary completion
- 2022-03-15
- Completion
- 2022-03-15
- First posted
- 2019-01-14
- Last updated
- 2022-03-16
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT03803111. Inclusion in this directory is not an endorsement.