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

NCT07087210 | Active Not Recruiting

• 1 other identifier: ICM 2022-3009
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Mitochondrial Function

Keywords

mitochondrial function; positron emission tomography; heart failure

Outcome Measures

Primary Outcomes (1)

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

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

  Up to 3 months

Secondary Outcomes (3)

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

  Up to 3 months

• 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 months

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

  Up to 3 months

Other Outcomes (1)

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

  Up to 3 months

Study Arms (3)

Active

engaged in aerobic exercise (running, cycling, or swimming) for at least 3 days per week or 5 hours per week without extensive layoff over the previous 6 months

Other: Positron Emission Tomography (PET)

Sedentary

≤1 structured physical activity per week

Other: Positron Emission Tomography (PET)

HFpEF

Chronic symptomatic HF and LVEF \>40% within 12 months before the screening visit (regardless of the imaging modality)

Other: Positron Emission Tomography (PET)

Interventions

Positron Emission Tomography (PET) OTHER

18F-TPP+ PET/CT imaging

Active; HFpEF; Sedentary

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

10 Active participants 10 Sedentary participants 10 HFpEF participants

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Matthieu Pelletier-Galarneau, MD MSc: lead

Study Sites (1)

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD MSc

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: July 25, 2025
• Study Start: November 25, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: July 25, 2025

Record last verified: 2025-07

Locations

CA (1)