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NCT Number: NCT07087210

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

About this study

Our study has three main goals:

  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Active participants:
  • ≥40 years old
  • LVEF ≥50%
  • Body Mass Index <35kg/m2
  • NYHA fuctional class I
  • 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
  • Non-smoker ≥1 year
  • Fasting glycemia <6.0 mmol/L
  • HbA1c <5.7%
  • Sedentary participants:
  • ≥40 years old
  • LVEF ≥50%
  • Body Mass Index <35kg/m2
  • NYHA fuctional class
  • ≤1 structured physical activity per week
  • Non-smoker ≥1 year
  • Fasting glycemia <6.0 mmol/L
  • HbA1c <5.7%
  • HFpEF participants:
  • Chronic symptomatic HF and LVEF >40% within 12 months before the screening visit (regardless of the imaging modality)
  • One of the following abnormalities:
  • HF requiring hospitallization and IV diuretics within 12 months of study entry
  • NTproBNP >150 pg/ml in sinus rhythm
  • NTproBNP >450 pg/ml in chronic atrial fibrillation

Exclusion criteria

  • for all participants :
  • Infiltrative CMP (e.g., cardiac amyloidosis)
  • Hypertrophic CMP
  • Dilated CMP
  • Ischemic CMP with myocardial infarction
  • Other chronic diseases or medications that may interfere with mitochondrial function
  • Primary severe valvular disease
  • Pericardial disease
  • Pacemaker
  • Defibrillator
  • Congenital heart disease
  • History of cardiac transplant
  • BMI >45 kg/m2
  • High resting blood pressure ≥150/90 mmHg
  • Estimated glomerular filtration rate (eGFR) <50 mL/min/1.73m2
  • Iodinated contrast allergy
  • Women of child bearing potential
  • Pregnancy
  • Breastfeeding
  • Inability to undergo the imaging logistics
  • Any condition that, in the opinion of the investigator, could compromise the participation in the study

Treatment and study plan

Positron Emission Tomography (PET)

Other

18F-TPP+ PET/CT imaging

Primary outcomes

  1. Average difference of membrane potential (ΔΨT) in sedentary adults vs subjects with Heart Failure with Preserved Ejection Fraction (HFpEF)

    Time frame: Up to 3 months

    Compare membrane potential (ΔΨT) of patients suffering from Heart Failure with Preserved Ejection Fraction (HFpEF) to healthy sedentary adults matched for age and sex.

Secondary outcomes

  1. Average difference of membrane potential (ΔΨT) in active adults vs healthy sedentary adults

    Time frame: Up to 3 months

    Compare membrane potential (ΔΨT) of healthy active adults to healthy sedentary adult matched for age and sex.

  2. Correlation coefficients between membrane potential (ΔΨT) and ECV vs VO2max, grip strength, left ventricular mass, NT-pro-BNP, neurocognitive function, and NYHA functional class.

    Time frame: Up to 5 months

    Evaluate 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.

  3. Coefficient of repeatability between membrane potential (ΔΨT) and ECV repeated measurements.

    Time frame: Up to 3 months

    Evaluate the repeatability of in vivo measurements of membrane potential (ΔΨT) and ECV.

Other outcomes

  1. Correlation between in vivo measurements of membrane potential (ΔΨT) and ECV with metabolites reflecting mitochondrial function.

    Time frame: Up to 3 months

    Explore the association between in vivo measurements of membrane potential (ΔΨT) and ECV with metabolites reflecting mitochondrial function.

Sponsors and collaborators

Lead sponsor

Matthieu Pelletier-Galarneau, MD MSc

Other

Registry information

Acronym: MITOMAP-HF

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jul 25, 2025
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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