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ID
Source
Brief title
Health condition
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).
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Is skeletal muscle metabolism impaired in HFpEF patients with iron deficiency, measured using CMR spectroscopy?
Secondary outcome
- Is microvascular function impaired in HFpEF patients with iron deficiency?
- Is exercise tolerance decreased in HFpEF patients with iron deficiency?
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
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 design
Not aplicable
Intervention
o Measurement of PCR recovery time using MR spectroscopy
- Microvascular function
o Glycocalyx thickness (um)
o Heat induced hyperaemic response (% skin hyperaemic response)
- Exercise tolerance
o 6 minute walk test distance (m)
o maximum exercise capacity (METs on exercise test)
Arantxa Barandiaran
Maastricht University Medical Centre, Department of Cardiology
Maastricht 6202 AZ
The Netherlands
+31(0)43-3871148
arantxa.barandiaranaizpurua@mumc.nl
Arantxa Barandiaran
Maastricht University Medical Centre, Department of Cardiology
Maastricht 6202 AZ
The Netherlands
+31(0)43-3871148
arantxa.barandiaranaizpurua@mumc.nl
Inclusion criteria
• 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
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7059 |
| NTR-old | NTR7297 |
| CCMO | NL65600.068.18 |
| OMON | NL-OMON55673 |