RECRUITING

Efficacy of Sodium Glucose Transporter Inhibitor (SGLT2I) in Adult Patients with Congenital Heart Disease

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Conditions

Adult Congenital Heart DiseaseHeart Failurecongenital heart diseasereduced exercise capacitydecreased cardiac function

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of the study is to investigate the feasibility and benefit of novel guideline-directed heart failure therapy drug Empagliflozin (Jardiance) for adult patients with congenital heart disease (ACHD).

Official Title

Efficacy of Sodium Glucose Transporter Inhibitor (SGLT2i) in Adult Patients with Congenital Heart Disease

Quick Facts

Study Start:2024-09-17
Study Completion:2027-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06260059

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnoses of Congenital Heart Disease
  2. * Age 18+
  3. * ACHD level of structural complexity II or III
  4. * Recent (\<6 months) decrease in systemic Ejection Fraction (confirmed by cardiac Echocardiogram, Computed Tomography or cMRI) to EF \< 60%
  5. * Recent decrease in systemic ejection fraction confirmed by cardiac Echo, CT or MRI by \> 5% in the last 6 months or less.
  6. * Must be able to complete neurocognitive assessments on a handheld computer.
  1. * Diagnosed with Diabetes
  2. * Contraindication to Jardiance/Entresto or any heart failure medication (per guideline-directed therapy, 2022).
  3. * Previous therapy with Jardiance at \<4 weeks
  4. * Glomerular Filtration Rate \<20
  5. * Pregnancy, breastfeeding, or planning to become pregnant in the coming year
  6. * History of liver disease - including non-alcoholic fatty liver disease (NAFLD) and cirrhosis
  7. * History of inborn error(s) of metabolism (including but is not exclusive of Glycogen storage disease type 1)
  8. * Glucose-galactose malabsorption, familial hyperinsulinism, maple syrup urine disease,
  9. * Gaucher disease,
  10. * Tay-Sachs disease,
  11. * Mucolipidosis IV,
  12. * Niemann-Pick disease,
  13. * Type A mitochondrial disease,
  14. * Metabolic disorders related to glucose metabolism

Contacts and Locations

Study Contact

Anita Saraf, MD, PhD
CONTACT
4128648661
sarafap@upmc.edu
Morgan Hindes
CONTACT
mhindes@chp.edu

Principal Investigator

Anita Saraf, MD, PhD
PRINCIPAL_INVESTIGATOR
Assistant Professor

Study Locations (Sites)

Magee Women's Hospital
Pittsburgh, Pennsylvania, 15213
United States
Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213
United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
United States

Collaborators and Investigators

Sponsor: Anita Saraf

  • Anita Saraf, MD, PhD, PRINCIPAL_INVESTIGATOR, Assistant Professor

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-17
Study Completion Date2027-06-01

Study Record Updates

Study Start Date2024-09-17
Study Completion Date2027-06-01

Terms related to this study

Keywords Provided by Researchers

  • congenital heart disease
  • reduced exercise capacity
  • decreased cardiac function

Additional Relevant MeSH Terms

  • Adult Congenital Heart Disease
  • Heart Failure