Oxidative skeletal muscle metabolism in chronic heart failure patients with and without iron deficiency

Recruiting

Conditions: heart failure
iron deficiency
10019280
10022958

Registration Number: NL-OMON52482

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 40

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% 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, as measured on echocardiography <1 year prior to inclusion;
- 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%.

For control subjects:
- No diagnosis of heart failure
- No diagnosis of severe vascular or (neuro-)muscular disease

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 enrollment
- Unable to understand study procedures
- Unable or unwilling to provide informed consent

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Bulk change of quadriceps phosphocreatine and inorganic phosphate content<br /><br>during exercise, pH time course during exercise and kinetics of oxidative ATP<br /><br>and phosphocreatine (PCr) resynthesis post-exercise.</p><br>

Secondary Outcome Measures