Oxidative Skeletal Muscle Metabolism in Chronic Heart Failure Patients With and Without Iron Deficiency

NCT ID: NCT05750940

Last Updated: 2023-03-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-05
• Study Completion Date: 2023-05-01

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.

Conditions

HF - Heart Failure; Iron-deficiency

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

31Phosphor Magnetic Resonance Spectroscopy

Measurement of skeletal oxidative metabolism with 31phosphor magnetic resonance spectroscopy

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Peter van der Meer, MD PhD

Prof. dr. Peter van der Meer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UMCG

Groningen, , Netherlands

Countries

Netherlands

Other Identifiers

201700917

Identifier Type: -

Identifier Source: org_study_id