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AORTIC VALVE DISEASESNCT07819344

Molecular Imaging to Identify Predictors of Aortic Valve Disease Activity

An observational study of AORTIC VALVE DISEASES and Calcification; Heart, run by Massachusetts General Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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Trial summary

This is a prospective study that aims to develop clinical calculators that will report on the underlying rate of aortic valve calcification. To do so, baseline 18FNaF PET/CT will be obtained to measure AS disease activity and the rate of active microcalcification. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
AORTIC VALVE DISEASES, Calcification; Heart
How many people
100 participants
Where
No sites listed yet
Study dates
30 Sep 2026to 30 Mar 2031
Phase
Observational

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 100 subjects with mild or moderate aortic stenosis

Who may be able to join

  • Males and females
  • aged 18 years or older
  • mild to moderate calcific Aortic Stenosis (as defined by standard echocardiographic criteria)

Who cannot join

  • Bicuspid Aortic Stenosis
  • pregnancy
  • cognitive disabilities that impair the ability to comply with instructions or provide informed consent
  • any other medical condition that may undermine participation
  • weight >300 lbs
  • severe claustrophobia
Show all 9Show fewer
  • Pregnancy
  • subjects who have had significant radiation exposure as part of research (>2 nuclear tests, computed tomography images, or fluoroscopic procedures) during the preceding 12 months
  • Individuals with renal dysfunction (eGFR<55) or a history of allergic reaction to iodinated contrast will not receive the iodinated contrast.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Ahmed Tawakol A Director, MD contact

6177262000 ext. 3699

atawakol@mgh.harvard.edu

About this study

Official title: Molecular Imaging and Deep Phenotyping to Identify Predictors of AS Disease Activity and Progression

This is a prospective study that aims to develop clinical calculators that will report on the underlying rate of aortic valve calcification. To do so, baseline 18FNaF PET/CT will be obtained to measure AS disease activity and the rate of active microcalcification. Using these data, multi-omics prediction models and calculator tools will be developed to provide an index of ongoing disease activity (active calcification). Follow-up imaging (both echo and CT) will be performed one year after baseline imaging to assess progression. We will test the hypothesis that baseline disease activity (as reported by the predictor models and calculators) is associated with the rate of annualized AS progression in two cohorts (the same cohort using subsequent imaging, as well as the Population Study's cohorts).

Read the detailed description

Structural imaging modalities, such as echocardiography (echo) and computed tomography (CT), measure the structural consequences of aortic valvular calcification and have proven invaluable for grading AS severity. However, these techniques cannot capture the dynamic microcalcification processes that drive the underlying disease and have proven insufficient for predicting AS progression. In contrast, molecular imaging with 18F-NaF positron emission tomography/computed tomography (18F-NaF PET/CT) is the gold-standard method for noninvasively measuring the central pathophysiological process driving the progression of AS. This imaging approach uses 18F-sodium fluoride, a tracer that binds preferentially to hydroxyapatite in regions of developing microcalcification. This enables quantification of microcalcification activity (which precedes visible macrocalcification) and provides insights into the underlying disease activity that drives AS progression. Notably, optimized protocols for 18F-NaF PET/CT yield a reproducible biomarker to track disease activity and predict progression. Furthermore, recent advances in PET technology (such as total-body PET scanners) have improved sensitivity by 10- to 40-fold, further enhancing the quantification of the microcalcification rate underlying AS progression.

Overall, the assessment of microcalcification activity shifts the focus from static anatomical assessments to measurement of the dynamic pathological process driving AS progression. However, while 18F-NaF PET/CT is unsuitable for routine clinical use (because it is costly and currently limited to research applications), it can be effectively leveraged to train predictive models and deploy them as clinical calculators to estimate the rate of microcalcification from readily available biomarker data. The resulting clinical models and calculators could greatly enhance clinical care by identifying patients at risk of rapid progression, refining risk stratification and prognostic accuracy, and opening avenues for personalized monitoring and treatment in calcific AS.

The overarching goal of this Clinical Imaging Study is to develop novel predictive models and clinical calculators that capture AS microcalcification activity and forecast the risk of progressive aortic valve stenosis among participants with mild-to-moderate AS. The investigators will achieve this by performing advanced multimodality imaging, including 18F-NaF PET/CT, to quantify microcalcification activity in deeply phenotyped patients using clinical, imaging, and blood plasma biomarkers. Computational approaches, including AI tools, will identify optimal combinations of imaging and non-imaging predictors of microcalcification activity. The investigators will then develop accessible clinical calculators and test the hypothesis that these models and calculators enhance identification of rapid progressors through cross-validation and external validation in the Population Project cohort (which undergoes identical biomarker phenotyping).

Keywords
aortic stenosis, calcification, positron emission tomography, calculator
Medical subject headings
Aortic Valve Disease, Calcinosis, Aortic Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07819344
Study groupRoleWhat they receive
Individuals with mild or moderate aortic stenosisMild or moderate aortic stenosis noted on imaging and not expected to undergo treatment of the aortic valve over the next year.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. rate of AS progression

    change of echo- and CT-derived AS measures

    Measured: One year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2026
  2. Study start30 Sep 2026 (estimated)
  3. Primary completion31 Mar 2030 (estimated)
  4. Study completion30 Mar 2031 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07819344
Sponsor's protocol ID
2026p001100
Other IDs
26SFRNPVHD1623048
Status last verified
Sep 2026
First submitted
8 Sep 2026
Last updated
16 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Otto CM, Newby DE, Hillis GS. Calcific Aortic Stenosis: A Review. JAMA. 2024 Dec 17;332(23):2014-2026. doi: 10.1001/jama.2024.16477.

    PubMed 39527048

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