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NCT Number: NCT07495267

Nutritional Ketosis Marfan

In this pilot clinical trial, the investigators will test whether a carefully supervised ketogenic diet can safely help people with Marfan syndrome who already have a chronic or residual aortic dissection. Fifteen participants will work with a study coordinator and dietitian to learn how to follow the diet and will have regular guidance and check-ins. The participants will measure their blood ketone levels at home with a simple finger-stick device and relay their readings to the research team. Every three months, blood samples will also be collected to confirm the body's level of ketosis.

Participants will continue their usual heart and blood-pressure medicines and regular visits with their doctors. Standard of care computed tomography (CT) scans of the aorta will be performed at the start of the study and then again at 6 and 12 months to see if the aorta changes in size.

The main goal is to see how many patients can avoid needing aortic surgery within one year, compared with what is normally expected from past studies. The investigators will also track how well patients follow the diet, how their aorta changes, and whether inflammation in their blood decreases.

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Key information

Conditions

Marfan Syndrome Abnormalities, Multiple Acute Aortic Syndrome Aneurysm Aortic Diseases Aortic Dissection Bone Diseases Bone Diseases, Developmental Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Dissection, Blood Vessel Genetic Diseases, Inborn Heart Defects, Congenital Heart Diseases Musculoskeletal Diseases Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults between 18 and 50 years old.
  • Ability to understand and willingness to sign an Institutional Review Board (IRB) approved written informed consent document.
  • Genetically or clinically confirmed Marfan syndrome
  • Chronic descending thoracic aortic dissection present for at least three months
  • Maximal descending thoracic aortic diameter must measure between 4.0 and 5.0 cm at baseline on contrast-enhanced computed tomography angiography (CTA)
  • Have been clinically stable and consistent antihypertensive regimen for at least four weeks

Exclusion criteria

  • Acute or rapidly enlarging dissection (>0.5 cm increase over the preceding three months)
  • Prior descending thoracic aortic repair or endograft placement
  • Advanced renal or hepatic dysfunction
  • Poorly controlled diabetes requiring insulin
  • Active malignancy, pregnancy, or other metabolic or nutritional disorders that would contraindicate ketogenic therapy
  • Body mass index below 18 kg/m²
  • Inability to comply with dietary restrictions or follow-up imaging
  • Current enrollment in another interventional study, which in the opinion of the principal investigator, may confound study results.
  • Patients who, in the opinion of the principal investigator, are not suitable candidates for study participation.

Treatment and study plan

Ketogenic diet

Other

Participants will continue ketogenic diet for 12 months.

Primary outcomes

  1. Freedom from aortic intervention

    Time frame: 12 months

    Freedom from aortic intervention at 12 months compared with historical controls.

Secondary outcomes

  1. Aortic dissection and inflammatory markers

    Time frame: 12 months

    Observation of changes related to aortic dissection and inflammatory markers

  2. Number of Participants who Maintained Diet Adherence measured by Ketone Monitor

    Time frame: From day 1 to 12 months

    In order to measure adherence, participants will use a handheld ketone meter (Keto-Mojo) to measure β-hydroxybutyrate levels three times per week via saliva as well as finger-stick blood testing.

Study contacts

Contact information is provided by the study sponsor or research team.

Kelly Koogler, RN, BSN

CONTACT

[email protected]

3142861506

Mohamed Zayed, MD, PhD, MBA, DFSVS, FAHA, FAC

CONTACT

[email protected]

(314) 362-5648

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Nutritional Ketosis as a Novel Therapeutic Strategy to Stabilize Chronic Aortic Dissection in Marfan Syndrome

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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