Heart Failure With Preserved Ejection Fraction Clinical Trial
Official title:
Exploring Intramyocellular Magnesium Augmentation: Implications for Myocardial and Skeletal Muscle Metabolism in Individuals With Heart Failure With Preserved Ejection Fraction
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.
Status | Not yet recruiting |
Enrollment | 85 |
Est. completion date | April 25, 2026 |
Est. primary completion date | February 28, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | General Inclusion Criteria - Participant is willing and able to give informed consent for participation in the study. - Participant aged at least 18 years old. 6.2.2 Additional inclusion criteria for participants in the HFpEF arm - Clinical diagnosis of HFpEF - HFA-PEFF score = 5 6.2.3 Additional inclusion criteria for participants in the healthy and matched control arm - HFA-PEFF < 3 - No known diagnosis of heart failure 6.3 Exclusion criteria - 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). - Chronic kidney disease stage 4/5 (due to contrast injection) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Oxford Centre for Magnetic Resonance (OCMR) | Oxford |
Lead Sponsor | Collaborator |
---|---|
University of Oxford | British Heart Foundation, Oxford University Hospitals NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Serum versus intracellular magnesium concentration | Comparing serum magnesium with intracellular magnesium concentrations using MRS, at all time points (pre-Mg infusion, and post (immediately and 7-15 days after) Mg infusion). | 7-15 days | |
Secondary | Cardiac function | Comparing systolic and diastolic function (echocardiography) at rest and exercise at the three time points (pre-Mg infusion, immediately post and delayed (7-15 days) after Mg infusion), and assessing if [Mg2+] has a stronger correlation with cardiac function than serum Mg2+. | 7-15 days | |
Secondary | Skeletal muscle performance | Comparing Calf raise test at the three time points (pre-Mg infusion, immediately post and delayed (7-15 days) after Mg infusion), and assessing if [Mg2+] has a stronger correlation with test performance than serum Mg2+. | 7-15 days | |
Secondary | Symptoms | To assess if Mg2+ infusion affects perceived exercise tolerance (NYHA class and symptom questionnaire) at 2 time points (pre-Mg infusion, and 7-15 days post-Mg infusion). | 7-15 days | |
Secondary | Insulin sensitivity | To assess if Mg2+ infusion affects a HOMA-IR score (based on fasted serum glucose and insulin levels).
To assess if Mg2+ infusion affects a HOMA-IR score (based on fasted serum glucose and insulin levels). To assess if Mg2+ infusion affects a HOMA-IR score (based on fasted serum glucose and insulin levels). To assess if Mg2+ infusion affects a HOMA-IR score (based on fasted serum glucose and insulin levels), comparing 2 time points (pre-Mg infusion, and 7-15 days post-Mg infusion). |
7-15 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Suspended |
NCT05839730 -
Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction
|
N/A | |
Recruiting |
NCT05095688 -
Relationship Between Adipose Tissue Distribution and Arterial Stiffness in HFpEF
|
||
Recruiting |
NCT06379152 -
Effect of Bilirubin on Prognosis in Heart Failure With Preserved Ejection Fraction
|
||
Recruiting |
NCT05676684 -
Dapagliflozin, Spironolactone or Both for HFpEF
|
Phase 2/Phase 3 | |
Recruiting |
NCT04153136 -
Effects of Sacubitril/Valsartan on Subclinical Heart Failure in HIV (The ENCHANTMENT HIV Study)
|
Phase 2 | |
Recruiting |
NCT05715697 -
Renal Denervation in Patients With Chronic Heart Failure With Preserved Ejection Fraction
|
N/A | |
Recruiting |
NCT06114498 -
Hospital Register of Decompensated Heart Failure With Preserved Ejection Fraction
|
||
Recruiting |
NCT04745013 -
PeRsonalIzed remOtely Guided Preventive exeRcIse Therapy for a healThY Heart
|
N/A | |
Completed |
NCT05586828 -
A Single-center Retrospective Cohort Study to Explore the Prognostic Significance of CONUT in Elderly CAD Patients With HFpEFand Compare CONUT With Other Objective Nutritional Indices.
|
||
Completed |
NCT05126836 -
Cilostazol for HFpEF
|
Phase 2 | |
Recruiting |
NCT04594499 -
The Relationship Between Pericardial Fat Thickness and Arterial Stiffness in HFpEF Patients
|
||
Active, not recruiting |
NCT05204238 -
Follow Up of acuTe Heart failUre: a pRospective Echocardiographic and Clinical Study (FUTURE)
|
||
Completed |
NCT04535726 -
The Relationship Between Blood Pressure and Arterial Stiffness in HFpEF Patients With Different Levels of Obesity
|
||
Recruiting |
NCT03550235 -
Exploration of Dyspnea at Non-high Brain Natriuretic Peptide (BNP)
|
||
Completed |
NCT04633460 -
Acute Effects of Exogenous Ketone Ester Administration in Heart Failure
|
Phase 2 | |
Completed |
NCT06228807 -
Clinical Characteristics and Predictors of Adverse Outcomes in HFpEF
|
||
Active, not recruiting |
NCT05284617 -
Exploratory Ph 2A, Double-Blind, Placebo-Controlled Dose Escalation Study of Safety, Tolerability, PD, & PK of HU6 for Subjects With Obese HFpEF
|
Phase 2 | |
Recruiting |
NCT05562063 -
Sotagliflozin in Heart Failure With Preserved Ejection Fraction (HFpEF) Patients
|
Phase 4 | |
Recruiting |
NCT06027307 -
Enavogliflozin Outcome Trial in Functional Tricuspid Regurgitation
|
Phase 3 | |
Withdrawn |
NCT05322616 -
Single-Ascending Dose Study of JK07 in Subjects With HFpEF
|
Phase 1 |