Effect of Iron deficiency on skeletetal muscle metabolisme in HFpEF

Completed

• Conditions: diastolic heart failure; iron deficiency; 10019280

• Registration Number: NL-OMON55673
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 78

Inclusion Criteria

All patients: presence of heart failure with preserved ejection fraction
(HFpEF) according to ESC guidelines: (1) signs and/or symptoms of heart failure
(2) LVEF >= 50%, (3) elevated levels of natriuretic peptide, (4) relevant
structural heart disease (LVmass index >95 in women, >115 in men; or LA
enlargement, LAVI >34 ml/m2), or diastolic dysfunction (E/e' >= 13, or e'<9).
Patients with Iron deficiency: serum ferritin < 100 µg/L or serum ferritin
between 100-299 µg/L in combination with a transferrin saturation < 20%.

Exclusion Criteria

- any iron supplement during last 6 months prior to inclusion
- any chemotherapy in last year
- significant peripheral artery disease
- contra indication for CMR, such as metallic implant, pacemaker/ICD or
claustrophobia, body weight >130kg.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameters is PCr/ATP ratio, a measurement of phosphocreatine to<br /><br>ATP ratio using MR spectroscopy. This assess skeletal muscle metabolism. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters/endpoints are:<br /><br>- Microvascular function (glycocalyx thickness, % skin hyperaemic response)<br /><br>- Exercise tolerance (6 minute walk test distance) </p><br>