Intracellular Magnesium and Heart Failure

NCT06353750 | Not Yet Recruiting

• 1 other identifier: 331039
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

Low magnesium levels are surprisingly common in those with a heart condition known as HFpEF, where the heart pumps well but is too rigid to fill properly with blood. While routine blood tests can check magnesium levels, they don't tell us how much magnesium is actually inside the heart and muscle cells, where it's vital for energy and overall function. Our research aims to get a clearer picture by looking directly at the magnesium inside these cells and understanding its role in the body's energy production and usage. We're also interested in how magnesium levels affect symptoms and the body's handling of sugar. We're using advanced medical imaging techniques, like heart magnetic resonance imaging (MRI) and other heart and muscle function tests, at rest and when the heart is working hard to help answer these questions. We'll compare the magnesium levels inside the cells before and after giving a supplement of magnesium to see if this can make a difference in how the heart and muscles work.

Conditions

Heart Failure With Preserved Ejection Fraction; Hypomagnesemia

Outcome Measures

Primary Outcomes (1)

• Myocardial/ skeletal muscle metabolism and energetics at rest and stress.

  Measuring myocardial metabolism (PCr/ATP, CK flux and KfCK, PDH flux), and skeletal muscle metabolism (PCr recovery Tau) at rest and stress. Measurements at three time points (pre-Mg infusion, immediately post and delayed (7-15 days) after Mg infusion, comparing HFpEF population with healthy and matched controls.

  7-15 days

Secondary Outcomes (5)

• Serum versus intracellular magnesium concentration

  7-15 days

• Cardiac function

  7-15 days

• Skeletal muscle performance

  7-15 days

• Symptoms

  7-15 days

• Insulin sensitivity

  7-15 days

Study Arms (3)

Individuals with heart failure with preserved ejection fraction (HFpEF)

* Clinical diagnosis of HFpEF * HFA-PEFF score ≥ 5

Other: Magnesium supplement

Healthy controls

* HFA-PEFF \< 3 * No known diagnosis of heart failure

Other: Magnesium supplement

Matched controls

* HFA-PEFF \< 3 * No known diagnosis of heart failure * Age and sex-matched individuals to the HFpEF cohort

Other: Magnesium supplement

Interventions

Magnesium supplement OTHER

Intravenous magnesium supplement (10mmol).

Healthy controls; Individuals with heart failure with preserved ejection fraction (HFpEF); Matched controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study investigators will contact those people who have participated in other ethically approved studies conducted at the research centre and have consented for their contact details to be retained in order to be contacted to take part in other research. Patients attending outpatient heart failure clinics will be identified by their routine clinical care team. Patients attending for clinical cardiac imaging as part of their routine care who indicate on their consent form that they are happy to take part in research will be identified by their routine clinical team.

You may qualify if:

• Participant is willing and able to give informed consent for participation in the study.
• Participant aged at least 18 years old.
• Clinical diagnosis of HFpEF
• HFA-PEFF score ≥ 5
• HFA-PEFF \< 3
• No known diagnosis of heart failure

You may not qualify if:

• Participant is unwilling or unable to give informed consent
• Any impediment to communication which, in the opinion of the investigator, might prevent the investigator communicating effectively with the patient during the study which could cause a safety or reliability concern.
• Any other condition which, in the opinion of the investigator, might affect the safety of the participant or reduce the reliability of the study results
• Involvement in any other research project where the procedures would affect the outcomes of this study.
• Individuals with NYHA class IV symptoms
• Known ischaemic heart disease, ICD, or CRT in situ.
• Individuals on oral magnesium supplementation
• Insulin dependent diabetes
• Standard contraindications to magnetic resonance imaging (MRI), (Metal clips or metallic foreign body, prior injury to the eye involving fragments of metal, prior shrapnel injuries, any other metallic or electronic implants affected by the magnetic field, history of severe claustrophobia, history of chronic kidneys disease, egg, or soya allergy)
• Heart transplant recipient
• Cardiomyopathy from infiltrative or storage diseases, muscular dystrophies, or with reversible causes, hypertrophic cardiomyopathy
• Moderate or greater valvular heart disease
• Acute HF requiring iv diuretics, inotropes, vasodilators, or hospitalisation within 6 weeks of screening
• BMI\>40kg/m2 (due to MRS sensitivity).
• Pregnancy (due to magnesium infusion).

Sponsors & Collaborators

• University of Oxford: lead
• British Heart Foundation: collaborator
• Oxford University Hospitals NHS Trust: collaborator

Study Sites (1)

Oxford Centre for Magnetic Resonance (OCMR)

Oxford, OX3 9DU, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

Central Study Contacts

Jennifer L Holland, BMBS

CONTACT

01865 221172; jennifer.holland@wolfson.ox.ac.uk

Oliver Rider, BM BCh

CONTACT

01865 221172; oliver.rider@cardiov.ox.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 9, 2024
• Study Start: April 15, 2024
• Primary Completion: February 28, 2026
• Study Completion: April 25, 2026
• Last Updated: April 9, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)