Phase 2 Heart Disease Trial, Recruiting NCT07083011 Sponsor: Mayo Clinic Condition: Heart Disease
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Phase 2 Heart Disease Trial, Recruiting

NCT07083011
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

This trial has three separate groups. Please read the group that may apply to you:

Group 1 – Heart Failure with Preserved Ejection Fraction (HFpEF):

  • You are 30 years of age or older and experience shortness of breath during physical activity
  • Your heart is pumping normally (as confirmed by a doctor), but you still have heart failure symptoms
  • Your body mass index (BMI) is 30 or above (considered obese range)
  • You have been newly diagnosed with this type of heart failure through a specialised heart pressure test (confirm with trial site)

Group 2 – Cardiac Sarcoidosis:

  • You are 18 years of age or older and are able to attend appointments as an outpatient (not currently hospitalised)
  • You have recently been referred to a Sarcoidosis clinic with a confirmed but not yet treated diagnosis of cardiac sarcoidosis
  • You have had a specific type of heart scan (18F-FDG PET scan) within the last 30 days that showed positive results

Group 3 – Healthy Volunteers:

  • You are 30 years of age or older
  • You do not have any major long-term health conditions affecting your heart, lungs, immune system, kidneys, liver, or a history of cancer
  • You do not regularly take medications such as blood thinners, blood pressure tablets, diabetes medications, immune-suppressing drugs, or similar (confirm with trial site for full list)

Who may not be able to join:

Group 1 – Heart Failure (HFpEF):

  • You have a primary heart muscle disease, disease around the heart, or significant heart valve problems
  • Your shortness of breath is caused by a lung condition or blocked heart arteries
  • You have severe anaemia (low red blood cells), or severe liver or kidney disease
  • You currently have active cancer
  • You have an active inflammatory or autoimmune condition such as rheumatoid arthritis or lupus
  • You were hospitalised in the last 30 days, or had a procedure to open blocked heart arteries in the last 90 days
  • You are already taking certain diabetes or weight-loss medications called SGLT2 inhibitors or GLP-1 agonists (confirm with trial site for specific drug names)
  • You are pregnant or breastfeeding
  • You are unable to lie flat for the required scans
  • You have severe claustrophobia, a cochlear implant, an implanted nerve stimulator, or other reasons you cannot safely have an MRI scan
  • You have a known allergy to gadolinium (a dye used in MRI scans)
  • You have a pacemaker, an implanted defibrillator, or an artificial heart valve

Group 2 – Cardiac Sarcoidosis:

  • You are already taking medications that suppress your immune system
  • You are pregnant or breastfeeding
  • You have severe liver or kidney disease, or are on dialysis
  • You had a procedure to open blocked heart arteries in the last 90 days
  • You currently have active cancer
  • You have a known allergy to gadolinium (a dye used in MRI scans)
  • You are unable to lie flat for the required scans
  • You have severe claustrophobia, a cochlear implant, an implanted nerve stimulator, or other reasons you cannot safely have an MRI scan
  • You have a pacemaker, an implanted defibrillator, or an artificial heart valve

Group 3 – Healthy Volunteers:

  • Your BMI is 30 or above
  • You are pregnant or breastfeeding
  • You have a known allergy to gadolinium (a dye used in MRI scans)
  • You are unable to lie flat for the required scans
  • You have severe claustrophobia, a cochlear implant, an implanted nerve stimulator, or other reasons you cannot safely have an MRI scan

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 21 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Omar Abou Ezzeddine, M.D, M.S, Mayo Clinic

Phone: 507-422-9485

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Registry
ClinicalTrials.gov
Start date
1 November 2025
Est. completion
1 July 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Myocardial 68Ga-FAPI (68Ga-Fibroblast Activation Protein Inhibitor) volume; Mean Standardized Uptake Value (SUVmean) and Max Standardized Uptake Value (SUVmax); Area of 68Ga-FAPI (68Ga-Fibroblast Activation Protein Inhibitor) uptake; 68Ga-FAPI target-to-background ratio

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov