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In Vivo Quantitative Mapping of Mitochondrial Cardiac Membrane Potential in Heart Failure

In Vivo Quantitative Mapping of Mitochondrial Cardiac Membrane Potential in Heart Failure

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07087210
Acronym
MITOMAP-HF
Enrollment
30
Registered
2025-07-25
Start date
2024-11-25
Completion date
2028-09-30
Last updated
2025-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitochondrial Function

Keywords

mitochondrial function, positron emission tomography, heart failure

Brief summary

This research aims to develop a new method to measure how well mitochondria are working using a special imaging technique called PET (positron emission tomography) with a tracer called 18F-TPP+. This tracer helps us visualize and measure mitochondrial function in a non-invasive way.

Detailed description

Our study has three main goals: 1. Measure Mitochondrial Function in Different Groups: The investigators will compare mitochondrial function in three groups: healthy active individuals, sedentary individuals, and heart failure patients. The investigators expect to see higher mitochondrial function in active individuals and lower function in heart failure patients. The investigators will also test the consistency of our measurements. 2. Correlate Mitochondrial Function with Health Indicators: The investigators will see if our mitochondrial function measurements relate to other health markers, such as exercise capacity, heart health, muscle strength, and cognitive function. 3. Improve the Production of the Tracer: The investigators will refine how they make the 18F-TPP+ tracer to make it more efficient and cost-effective for widespread use in research and clinical settings.

Interventions

OTHERPositron Emission Tomography (PET)

18F-TPP+ PET/CT imaging

Sponsors

Matthieu Pelletier-Galarneau, MD MSc
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Active participants: 1. ≥40 years old 2. LVEF ≥50% 3. Body Mass Index \<35kg/m2 4. NYHA fuctional class I 5. Engaged in aerobic exercise (running cycling or swimming) for ≥3 days per week or 5 hours per week without extensive layoff over the previous 6 months 6. Non-smoker ≥1 year 7. Fasting glycemia \<6.0 mmol/L 8. HbA1c \<5.7% * Sedentary participants: 1. ≥40 years old 2. LVEF ≥50% 3. Body Mass Index \<35kg/m2 4. NYHA fuctional class 5. ≤1 structured physical activity per week 6. Non-smoker ≥1 year 7. Fasting glycemia \<6.0 mmol/L 8. HbA1c \<5.7% * HFpEF participants: 1. Chronic symptomatic HF and LVEF \>40% within 12 months before the screening visit (regardless of the imaging modality) 2. One of the following abnormalities: 1. HF requiring hospitallization and IV diuretics within 12 months of study entry 2. NTproBNP \>150 pg/ml in sinus rhythm 3. NTproBNP \>450 pg/ml in chronic atrial fibrillation

Exclusion criteria

* for all participants : 1. Infiltrative CMP (e.g., cardiac amyloidosis) 2. Hypertrophic CMP 3. Dilated CMP 4. Ischemic CMP with myocardial infarction 5. Other chronic diseases or medications that may interfere with mitochondrial function 6. Primary severe valvular disease 7. Pericardial disease 8. Pacemaker 9. Defibrillator 10. Congenital heart disease 11. History of cardiac transplant 12. BMI \>45 kg/m2 13. High resting blood pressure ≥150/90 mmHg 14. Estimated glomerular filtration rate (eGFR) \<50 mL/min/1.73m2 15. Iodinated contrast allergy 16. Women of child bearing potential 17. Pregnancy 18. Breastfeeding 19. Inability to undergo the imaging logistics 20. Any condition that, in the opinion of the investigator, could compromise the participation in the study

Design outcomes

Primary

MeasureTime frameDescription
Average difference of membrane potential (ΔΨT) in sedentary adults vs subjects with Heart Failure with Preserved Ejection Fraction (HFpEF)Up to 3 monthsCompare membrane potential (ΔΨT) of patients suffering from Heart Failure with Preserved Ejection Fraction (HFpEF) to healthy sedentary adults matched for age and sex.

Secondary

MeasureTime frameDescription
Average difference of membrane potential (ΔΨT) in active adults vs healthy sedentary adultsUp to 3 monthsCompare membrane potential (ΔΨT) of healthy active adults to healthy sedentary adult matched for age and sex.
Correlation coefficients between membrane potential (ΔΨT) and ECV vs VO2max, grip strength, left ventricular mass, NT-pro-BNP, neurocognitive function, and NYHA functional class.Up to 5 monthsEvaluate the correlation between membrane potential (ΔΨT) and ECV with clinical biomarkers of HF including VO2max, grip strength, left ventricular mass, NT-pro-BNP, neurocognitive function, and NYHA functional class.
Coefficient of repeatability between membrane potential (ΔΨT) and ECV repeated measurements.Up to 3 monthsEvaluate the repeatability of in vivo measurements of membrane potential (ΔΨT) and ECV.

Other

MeasureTime frameDescription
Correlation between in vivo measurements of membrane potential (ΔΨT) and ECV with metabolites reflecting mitochondrial function.Up to 3 monthsExplore the association between in vivo measurements of membrane potential (ΔΨT) and ECV with metabolites reflecting mitochondrial function.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026