HF - Heart Failure, Iron-deficiency
Conditions
Keywords
31P MRS, 31Phosphor Magnetic Resonance Spectroscopy, HFpEF, HFrEF, Oxidative Skeletal Muscle Metabolism
Brief summary
Observational study using in vivo noninvasive 31 phosphor magnetic resonance spectroscopy (31P MRS) to quantify the effect of iron deficiency (ID) on skeletal oxidative metabolism in patients with chronic heart failure (HF).
Detailed description
Iron Deficiency (ID) is a comorbidity in heart failure (HF) patients with high prevalence and severe clinical consequences. Multiple studies have shown that ID in HF patients impairs exercise capacity, quality of life and outcome. It is currently unknown whether these detrimental consequences of ID are due to cardiovascular or hematologic effects, or deteriorated peripheral muscle metabolism and function. This study was designed to quantify the effect of ID on skeletal oxidative metabolism in patients with chronic HF.
Interventions
DIAGNOSTIC_TEST31Phosphor Magnetic Resonance Spectroscopy
Measurement of skeletal oxidative metabolism with 31phosphor magnetic resonance spectroscopy
Sponsors
University Medical Center Groningen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For HFrEF patients: * Diagnosis of chronic HF of either ischemic or non-ischemic etiology; * Stable, evidence-based medical therapy for HF; * LVEF \<40% measured \<5 year prior to inclusion; * NYHA class II - III (symptomatic HF) at moment of inclusion; For HFpEF patients: * Diagnosis of chronic HF of either ischemic or non-ischemic etiology; * LVEF \>40% and one of the following parameters, measured \<5 year prior to inclusion; * Left atrial volume index (LAVI) \>34 mL/m2 or * left ventricular mass index ≥115 g/m2 (for males) or ≥95 g/m2 (for females) or * E/e' ≥13 or * mean e' (septal and lateral) \<9 cm/s * NYHA class II - III (symptomatic HF) at moment of inclusion; * Serum NT-proBNP ≥125 pg/mL when in sinus rhythm; \>300 pg/mL when in atrial fibrillation. Additional inclusion criterion for subjects with ID: \- Iron deficiency, defined as TSAT \<20%.
Exclusion criteria
* Age \<18 years; * Unable or unwilling to undergo exercise MRI (e.g. pregnancy, physical disabilities, claustrophobia); * The presence of ferromagnetic material in/on the body which cannot be removed (e.g. non-MRI-compatible cardiac devices, tattoos containing ferrous ink); * History of erythropoietin stimulating agent, intravenous iron therapy and/or blood transfusion \<3 months prior to study enrolment; * Moderate anaemia, defined as Hb \<7 mmol/L for both men and women; * Oral iron therapy \>100 mg/day \<4 weeks prior to study enrolment; * Unable to understand study procedures; * Unable or unwilling to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ΔPi/PCr from baseline to maximum exercise | During study visit, from resting baseline to maximum exercise (from start exercise upto exhaustion for a maximum timeframe of 10 minutes) | Δ ratio of inorganic phosphate/Phosphocreatinin concentrations from baseline to maximum exercise |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PCr recovery rate during recovery | During study visit, from maximum exercise to end of recovery (upto at least 5 minutes after end of exercise) | Post-exercise phosphocreatinin recovery rate |
| Intramuscular pH | During study visit, during exercise (from start exercise upto exhaustion for a maximum timeframe of 10 minutes) | Rates and magnitude of change in intramuscular pH during exercise |
| Maximal exercise performance | During study visit, during exercise (from start exercise upto exhaustion for a maximum timeframe of 10 minutes) | Maximal exercise performance |
Countries
Netherlands
Outcome results
None listed