To quantify the effect of ID on skeletal oxidative metabolism in patients with chronic HF with either preserved (HFpEF) or reduced (HFrEF) left ventricular ejection fraction.
ID
Source
Brief title
Condition
- Heart failures
- Iron and trace metal metabolism disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Bulk change of quadriceps phosphocreatine and inorganic phosphate content
during exercise, pH time course during exercise and kinetics of oxidative ATP
and phosphocreatine (PCr) resynthesis post-exercise.
Secondary outcome
Not applicable.
Background summary
Iron deficiency (ID) is 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.
Study objective
To quantify the effect of ID on skeletal oxidative metabolism in patients with
chronic HF with either preserved (HFpEF) or reduced (HFrEF) left ventricular
ejection fraction.
Study design
Observational study using in vivo noninvasive 31P magnetic resonance
spectroscopy to determine oxidative skeletal muscle metabolism at rest and
during incremental exercise.
Study burden and risks
Participating subjects visit the UMCG only once for approximately one and a
half hour. Eligible subjects will be screened for contra-indications for either
MRI testing and/or (maximal) exercise testing. Subjects with contra-indications
for (maximal) exercise MRI testing will not be enrolled in the study. Subjects
do not have direct benefits from participating in this study. Previously
conducted 31P MRS studies in adult subjects with muscular diseases, cystic
fibrosis and chronic heart failure showed no adverse and/or serious adverse
events.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL64308.042.18 |