Status:
UNKNOWN
Ferric Carboximaltose on Intra-myocardial Iron Load in Patients With Heart Failure
Lead Sponsor:
Hospital Moinhos de Vento
Collaborating Sponsors:
Takeda
Conditions:
Cardiac Failure
Systolic Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
In general, anemia is associated with a greater presence of HF symptoms, worsening NYHA functional class, higher rate of hospitalization for heart failure, and reduced survival. However, it is unclear...
Detailed Description
Anemia (defined as a hemoglobin concentration below 13 g / dL in men and less than 12 g / dL in women) is a condition frequently associated with heart failure (HF), and its prevalence is estimated at ...
Eligibility Criteria
Inclusion
- Left ventricular ejection fraction \<40% assessed by transthoracic echocardiography or cardiac magnetic resonance with at least 3 months.
- Serum ferritin \< 100µg/L or 100-299µg/L with transferrin saturation \< 20%
- clinical stability during last 3 months
Exclusion
- Use of intracardiac defibrillator or pacemaker.
- Severe to moderate valvar heart disease
- Clinical instability, acute coronary syndrome and cardiac surgery within 3 months.
Key Trial Info
Start Date :
August 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03871699
Start Date
August 30 2019
End Date
February 28 2021
Last Update
July 12 2019
Active Locations (1)
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1
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil, 90440050