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

Iron-deficiency Clinical Trial

— FERRIFY  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05750940
• Other study ID #: 201700917
• Status: Enrolling by invitation
• Start date: October 5, 2021
• Est. completion date: May 1, 2023

Study information

• Verified date: February 2023
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: May 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Heart Failure
• HF - Heart Failure
• Iron-deficiency

Intervention

Diagnostic Test:
• 31Phosphor Magnetic Resonance Spectroscopy
Measurement of skeletal oxidative metabolism with 31phosphor magnetic resonance spectroscopy

Locations

Country	Name	City	State
Netherlands	UMCG	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	?Pi/PCr from baseline to maximum exercise	? ratio of inorganic phosphate/Phosphocreatinin concentrations from baseline to maximum exercise	During study visit, from resting baseline to maximum exercise (from start exercise upto exhaustion for a maximum timeframe of 10 minutes)
Secondary	PCr recovery rate during recovery	Post-exercise phosphocreatinin recovery rate	During study visit, from maximum exercise to end of recovery (upto at least 5 minutes after end of exercise)
Secondary	Intramuscular pH	Rates and magnitude of change in intramuscular pH during exercise	During study visit, during exercise (from start exercise upto exhaustion for a maximum timeframe of 10 minutes)
Secondary	Maximal exercise performance	Maximal exercise performance	During study visit, during exercise (from start exercise upto exhaustion for a maximum timeframe of 10 minutes)