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 range
18 Years
Sex
ALL
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)