Objective: To assess if skeletal muscle metabolism is impaired in HFpEF patients with iron deficiency compared to HFpEF patients without iron deficiency?
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters is PCr/ATP ratio, a measurement of phosphocreatine to
ATP ratio using MR spectroscopy. This assess skeletal muscle metabolism.
Secondary outcome
Secondary parameters/endpoints are:
- Microvascular function (glycocalyx thickness, % skin hyperaemic response)
- Exercise tolerance (6 minute walk test distance)
Background summary
Diabetes, obesity and hypertension, all highly present comorbidities in HFpEF,
seem to drive this disease by inducing low-grade systemic inflammation which in
turn induces microvascular dysfunction and activates a cascade of events.
Several studies have demonstrated that HFpEF is a systemic disease that affects
not only cardiac, but also peripheral muscle energy metabolism. Iron deficiency
(ID) could be an important contributor in this pathophysiological process.
Iron deficiency is present in 50% of chronic HF patients. Although HFpEF was
not excluded from these cohort studies, it mainly included HF with reduced
ejection fraction (HFrEF).
We hypothesize that ID is an important factor in the limitation of exercise
capacity in HFpEF. Systemic low-grade inflammation does not only lead to
microvascular dysfunction but also to iron deficiency. Iron deficiency has a
direct effect on the muscle. Not only on the cardiac muscle but also the
skeletal muscle is affected, impairing muscle contraction strength but also
energy metabolism. The primary focus of this study will be delivering proof
that the alterations in the muscle are more severe in HFpEF patients with ID
compared to without ID.
Study objective
Objective:
To assess if skeletal muscle metabolism is impaired in HFpEF patients with iron
deficiency compared to HFpEF patients without iron deficiency?
Study design
Prospective case-control study
Study burden and risks
There is a minimal burden associated with participation in this study.
Measurements of ID are performed as part of routine examinations in the
outpatient clinic.
1. MR spectroscopy is a non-invasive, non-radiation imaging technique. CMR has
a low risk of contrast reaction. To date, MRI investigations have been
performed in over 200 million patients. Worldwide and are regarded as extremely
safe. MRI is painless and has no known short-term or long-term biological
adverse effects. Deaths have only been reported when proper safety precautions
were not taken.
Risks: There are very few risks known to be associated with MRI:
Changing radiofrequency pulses may produce heat. This is not known to cause any
side effects. Loose metal objects in the patient or in the scanner room may
cause damage to
the patient. When appropriate precautions are taken, this is rare to occur.
2.Glycocalyx thickness measurement is a non-invasive, endothelial function
measurement method. This method has no contra-indications or adverse effects.
3.Heat-induced skin hyperaemic response, is a non-invasive, endothelial
function measurement method. This method has no contraindications or adverse
effects. The warm electrodes (warmth until 44° C) are not painful and just a
slight local warmth can be felt.
P. Debeyelaan 25
Maastricht 6229 HX
NL
P. Debeyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL65600.068.18 |
OMON | NL-OMON20027 |