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

NCT05750940 | Unknown

• 1 other identifier: 201700917
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

HF - Heart Failure; Iron-deficiency

Keywords

31P MRS; 31Phosphor Magnetic Resonance Spectroscopy; HFpEF; HFrEF; Oxidative Skeletal Muscle Metabolism

Outcome Measures

Primary Outcomes (1)

• ΔPi/PCr from baseline to maximum exercise

  Δ 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 Outcomes (3)

• PCr recovery rate during recovery

  During study visit, from maximum exercise to end of recovery (upto at least 5 minutes after end of exercise)

• Intramuscular pH

  During study visit, during exercise (from start exercise upto exhaustion for a maximum timeframe of 10 minutes)

• Maximal exercise performance

  During study visit, during exercise (from start exercise upto exhaustion for a maximum timeframe of 10 minutes)

Interventions

31Phosphor Magnetic Resonance Spectroscopy DIAGNOSTIC_TEST

Measurement of skeletal oxidative metabolism with 31phosphor magnetic resonance spectroscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

For this study, we will include 40 non-anaemic patients with stable chronic HF, subdivided in 20 patients with HFrEF and 20 subjects with HFrEF. HFpEF and HFrEF patients will be further subdivided into 10 patients with ID and 10 patients without ID. These patients will be recruited from the outpatient clinic of the Department of Cardiology, UMCG. Patients must be stable at the time of inclusion (i.e. no medication changes \<1 month prior to study).

You may qualify if:

• For HFrEF patients:
• Diagnosis of chronic HF of either ischemic or non-ischemic etiology;
• Stable, evidence-based medical therapy for HF;
• For HFpEF patients:
• Diagnosis of chronic HF of either ischemic or non-ischemic etiology;
• 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
• Serum NT-proBNP ≥125 pg/mL when in sinus rhythm; \>300 pg/mL when in atrial fibrillation.
• \- Iron deficiency, defined as TSAT \<20%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

UMCG

Groningen, 9713GZ, Netherlands

Location

MeSH Terms

Conditions

Heart Failure; Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr. Peter van der Meer

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: March 2, 2023
• Study Start: October 5, 2021
• Primary Completion: April 1, 2023
• Study Completion: May 1, 2023
• Last Updated: March 2, 2023

Record last verified: 2023-02

Locations

NL (1)