Oxidative Skeletal Muscle Metabolism in Chronic Heart Failure Patients With and Without Iron Defi… (NCT05750940) | Clinical Trial Compass
UnknownNot Applicable
Oxidative Skeletal Muscle Metabolism in Chronic Heart Failure Patients With and Without Iron Deficiency
Netherlands40 participantsStarted 2021-10-05
Plain-language 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).
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 procedur…
What they're measuring
1
ΔPi/PCr from baseline to maximum exercise
Timeframe: During study visit, from resting baseline to maximum exercise (from start exercise upto exhaustion for a maximum timeframe of 10 minutes)