Mitochondrial FunctionMITOMAP-HFNCT07087210
In Vivo Quantitative Mapping of Mitochondrial Cardiac Membrane Potential in Heart Failure
An observational study of Mitochondrial Function, run by Matthieu Pelletier-Galarneau, MD MSc at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mitochondrial Function
- What is being tested?
- Positron Emission Tomography (PET)
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 25 Nov 2024to Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 10 Active participants 10 Sedentary participants 10 HFpEF participants
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Mitochondrial Function
- Being tested
- Positron Emission Tomography (PET)
- Keywords
- mitochondrial function, positron emission tomography, heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positron Emission Tomography (PET)Other
18F-TPP+ PET/CT imaging
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Positron Emission Tomography (PET) | |
| Sedentary | ≤1 structured physical activity per week Receives: Other: Positron Emission Tomography (PET) | |
| HFpEF | Chronic symptomatic HF and LVEF >40% within 12 months before the screening visit (regardless of the imaging modality) Receives: Other: Positron Emission Tomography (PET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 months
Secondary outcomes (3)
Average difference of membrane potential (ΔΨT) in active adults vs healthy sedentary adults
Compare membrane potential (ΔΨT) of healthy active adults to healthy sedentary adult matched for age and sex.
Measured: 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.
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.
Measured: Up to 5 months
Coefficient of repeatability between membrane potential (ΔΨT) and ECV repeated measurements.
Evaluate the repeatability of in vivo measurements of membrane potential (ΔΨT) and ECV.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start25 Nov 2024
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitochondrial FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Matthieu Pelletier-Galarneau, MD MSc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Matthieu Pelletier-Galarneau, MD MSc, Montreal Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07087210
- Sponsor's protocol ID
- ICM 2022-3009
- Acronym
- MITOMAP-HF
- Status last verified
- Jul 2025
- First submitted
- 28 Mar 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Quantitative Mapping of Mitochondrial Cardiac Membrane Potential in Heart Failure
- ClinicalTrials.gov ID
- NCT07087210
- Acronym / sponsor ID
- MITOMAP-HF / ICM 2022-3009
- Conditions
- Mitochondrial Function
- Keywords
- mitochondrial function, positron emission tomography, heart failure
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Matthieu Pelletier-Galarneau, MD MScUniversity, hospital or other
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 25 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active | – | Other: Positron Emission Tomography (PET)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 |
| Sedentary | – | Other: Positron Emission Tomography (PET)≤1 structured physical activity per week |
| HFpEF | – | Other: Positron Emission Tomography (PET)Chronic symptomatic HF and LVEF >40% within 12 months before the screening visit (regardless of the imaging modality) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 10 Active participants 10 Sedentary participants 10 HFpEF participants
Key inclusion criteria (24 listed)
- Active participants:
- Sedentary participants:
- HFpEF participants:
Key exclusion criteria (21 listed)
- for all participants :
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positron Emission Tomography (PET)18F-TPP+ PET/CT imaging | Other | Active, HFpEF, Sedentary |
Primary outcome
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.
3 secondary outcomes
Average difference of membrane potential (ΔΨT) in active adults vs healthy sedentary adults
Time frame: 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.
Time frame: Up to 5 months
Coefficient of repeatability between membrane potential (ΔΨT) and ECV repeated measurements.
Time frame: Up to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitochondrial Function, run by Matthieu Pelletier-Galarneau, MD MSc at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.