Effect of ferric carboxymaltose on exercise capacity in patients with iron deficiency and chronic heart failure
- Conditions
- Iron deficiency in patients with chronic heart failureMedDRA version: 16.0Level: LLTClassification code 10008908Term: Chronic heart failureSystem Organ Class: 100000004849MedDRA version: 16.0Level: PTClassification code 10022970Term: Iron deficiencySystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2011-000603-40-ES
- Lead Sponsor
- Vifor (International) Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 160
1. Iron deficient subjects with stable chronic heart failure (CHF) (NYHA II-III) on optimal background therapy for CHF
2. Reduced exercise capacity
3. Reduced left ventricular ejection fraction
4. At least 18 years of age and with written informed consent prior to any study specific procedures.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 64
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 96
1. Erythropoietin stimulating agent (ESA) use, IV iron therapy, and/or blood transfusion in previous 6 weeks prior to randomisation
2. Exercise training program(s) in the 3 months prior to screening or planned in the next 6 months
3. Chronic liver disease and/or elevated liver enzymes
4. Vitamin B12 and/or serum folate deficiency that requires treatment
5. Subject is not using adequate contraceptive precautions during the study
6. No other significant cardiac or general disorder that would compromise participation in the study.
7. Subjects with body weight <35 kg
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: 1. To evaluate the efficacy of IV FCM compared to usual care on biomarkers for iron deficiency (ID), cardiac biomarkers, New York Heart Association (NYHA) functional class, patient global assessment (PGA), quality of life (QoL), renal function, cardiac function as assessed by echocardiography (ECHO) and iron requirements in iron-deficient chronic heart failure (CHF) subjects.<br><br>2. To evaluate the safety of intravenous ferric carboxymaltose over the treatment period.;Primary end point(s): Change in peak VO2 (mL/kg/min) from baseline to Week 24;Timepoint(s) of evaluation of this end point: Week 24;Main Objective: 1. To evaluate the efficacy of intravenous ferric carboxymaltose compared to usual care on exercise capacity.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Change in peak VO2 (mL/kg/min) from baseline to Week 12<br>2. Change in minute ventilation-carbon dioxide production slope from baseline to Weeks 12 and 24<br>3. Changes from baseline to Weeks 6, 12 and 24 in:<br> ? Key laboratory and iron parameters<br> ? Cardiac biomarkers (including BNP and NT-proBNP)<br> ? NYHA<br> ? PGA<br> ? QoL (Kansas City cardiomyopathy questionnaire (KCCQ) and European quality of life 5D questionnaire (EQ-5D))<br> - ECHO measurements<br>4. Cumulative iron requirements and number of iron administrations over the study period<br>5. Percentage of subjects meeting key safety endpoint defined as time to:<br> ? Death<br> ? (First) hospitalisation for worsening heart failure<br> ? Heart transplantation;Timepoint(s) of evaluation of this end point: 1. Week 12<br>2. Week 12 & Week 24<br>3. Week 6, Week 12, & Week 24<br>4. End of Study<br>5. End of Study