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Effect of Iron Deficiency on skeletal muscle metabolism in HFpEF

Recruiting
Conditions
Heart failure with preserved ejection fraction and iron deficiency
Registration Number
NL-OMON21811
Lead Sponsor
Vifor pharma
Brief Summary

one

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
78
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

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

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
-Is skeletal muscle metabolism impaired in HFpEF patients with iron deficiency, measured using CMR spectroscopy?
Secondary Outcome Measures
NameTimeMethod
<br>-Is microvascular function impaired in HFpEF patients with iron deficiency? <br>-Is exercise tolerance decreased in HFpEF patients with iron deficiency? <br>
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