Heart failure with preserved ejection fraction and iron deficiency
Conditions
Interventions
The main study parameters is PCR recovery time, a measurement of PCR recovery time using MR spectroscopy
Secondary parameters/endpoints are:
- Microvascular function
o Glycocalyx thickness (um)
o H
Sponsors
Vifor pharma
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: Group I HFpEF with iron deficiency Group II HFpEF without iron deficiency • HFpEF: according to the ESC guidelines (1) Signs and/or symptoms of heart failure, (2) LVEF = 50%, (3) Elevated levels of natriuretic peptide (NT-proBNP > 125 pg/ml ~ 15 pmol/L) (4) one of the following additional criteria a) Relevant structural heart disease; LV hypertrophy, (LVmass index > 95 g/m2 in women, or >115 g/m2 in men) and/or LA enlargement (LA volume index >34 l/m2) b) Diastolic dysfunction (E/e’ = 13, mean e’ septal and lateral wall < 9 cm/s) • Iron deficiency: serum ferritin < 100 µg/L or serum ferritin between 100-299 µg/L in combination with a transferrin saturation < 20%.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Reproductive age women - Any iron supplement (oral, iv) during the last 6 months prior to inclusion - Any chemotherapy in last year - Significant peripheral artery disease - Contraindication for CMR • ODIN protocol: • “Uitvoering van MRI onderzoek bij patiënten met een cardiaal implanteerbaar elektronisch device (CIED), waaronder een pacemaker en ICD” • ODIN protocol: • “Voorbereiding klinische patiënten voor MRI onderzoek” • Metallic implant (vascular clip, neuro-stimulator, cochlear implant) • Pacemaker or implantable cardiac defibrillator(ICD) • Claustrophobia - Body weight > 130kg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Is skeletal muscle metabolism impaired in HFpEF patients with iron deficiency, measured using CMR spectroscopy? | — |
Secondary
| Measure | Time frame |
|---|---|
| - Is microvascular function impaired in HFpEF patients with iron deficiency? - Is exercise tolerance decreased in HFpEF patients with iron deficiency? | — |
Contacts
Public ContactArantxa Barandiaran Aizpurua
arantxa.barandiaranaizpurua@mumc.nl
Outcome results
None listed