Iron Substitution With Ferric Carboxymaltose as Treatment Strategy for Heart Failure Patients With Preserved Ejection Fraction

• Status: Withdrawn
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to investigate the effects of treatment with intravenous ferric carboxymaltose on exercise tolerance measured as VO2peak in patients with HFpEF and iron deficiency, compared to placebo.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cantonal Hosptal, Baselland
• Collaborator: Clinical Trial Unit, University Hospital Basel, Switzerland

Criteria

Inclusion Criteria:

• Informed consent as documented by signature

• NYHA functional classes II-III

• Signs and symptoms of chronic HF, such as:

• Dyspnea

• Paroxysmal nocturnal dyspnea

• Reduced exercise tolerance

• Fatigue

• Extended recovery after exercising

• Peripheral edema (lower leg, ankle)

• EF (ejection fraction) >50%

• Structural or functional changes in echocardiography:

• Left atrial volume index (LAVI) >34 ml/m2 OR

• Left ventricular mass index (LVMI) >115 g/m2 (men), >95 g/m2 (women) OR

• E/E' (ratio between mitral peak velocity of early filling (E) to early diastolic mitral annular velocity (E')) >13 AND mean E' septal and lateral wall <9 cm/s

• NT-proBNP >125 pg/ml

• At least 4 weeks on stable medical treatment or without signs and symptoms of cardiac decompensation

• Iron deficiency defined as:

• Ferritin <100 ng/ml OR

• Ferritin <300 ng/ml with a transferrin saturation (TSAT) <20%

Exclusion Criteria:

• Age <18 years

• Pregnancy or lactation

• Life-expectancy <6 months

• Planned cardiac interventions in the following 6 months

• Unstable angina pectoris

• Uncontrolled brady- or tachyarrhythmia

• Severe uncorrected valvular heart disease

• Paroxysmal atrial fibrillation

• Clinically significant concomitant disease states (e.g. hypertension grades 2-3 (>160/100 mmHg), severe renal failure (GFR <30 ml/min/1.73m2), hepatic dysfunction (ALT or AST >3x upper limit of normal, chronic obstructive pulmonary disease (COPD) grades III-IV)

• On-going cancer treatment

• Significant musculoskeletal disease limiting exercise tolerance

• Active infection

• Immunosuppressive medical therapy

• Earlier hypersensitivity to parenteral iron preparation

• Anemia and iron deficiency due to active and/or chronic bleeding

• Blood transfusion within the previous 30 days

• Red cell, folate and vitamin B12 deficiency

• Known or suspected non-compliance, drug or alcohol abuse

• Inability to follow the procedures of the study, e.g. due to insufficient language skills, psychological disorders, dementia, etc.

• Participation in another intervention study

• Enrolment of the investigators, their family members, and other persons involved in the study procedures

• Hemoglobin < 120 ng/ml in male patients or < 110 ng/ml in female patients