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

NCT ID: NCT07087210

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-25
• Study Completion Date: 2028-09-30

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.

Conditions

Mitochondrial Function

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Positron Emission Tomography (PET)

Intervention Type: OTHER

18F-TPP+ PET/CT imaging

Sedentary

≤1 structured physical activity per week

Positron Emission Tomography (PET)

Intervention Type: OTHER

18F-TPP+ PET/CT imaging

HFpEF

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

Positron Emission Tomography (PET)

Intervention Type: OTHER

18F-TPP+ PET/CT imaging

Interventions

Positron Emission Tomography (PET)

18F-TPP+ PET/CT imaging

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Matthieu Pelletier-Galarneau, MD MSc

OTHER

Sponsor Role: lead

Responsible Party

Matthieu Pelletier-Galarneau, MD MSc

MD MSc

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Montreal Heart Institute

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

ICM 2022-3009

Identifier Type: -

Identifier Source: org_study_id