RECRUITING

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

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).

Conditions

Adult Congenital Heart DiseaseHeart Failure
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Related Conditions:

Adult Congenital Heart DiseaseHeart Failure

Study Overview

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Study Details

Study overview

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).

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

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

Condition
Adult Congenital Heart Disease
Intervention / Treatment

-

Contacts and Locations

Pittsburgh

Magee Women's Hospital, Pittsburgh, Pennsylvania, United States, 15213

Pittsburgh

Presbyterian Hospital, Pittsburgh, Pennsylvania, United States, 15213

Pittsburgh

Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United States, 15224

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Diagnoses of Congenital Heart Disease
  • * Age 18+
  • * ACHD level of structural complexity II or III
  • * Recent (\<6 months) decrease in systemic Ejection Fraction (confirmed by cardiac Echocardiogram, Computed Tomography or cMRI) to EF \< 60%
  • * Recent decrease in systemic ejection fraction confirmed by cardiac Echo, CT or MRI by \> 5% in the last 6 months or less.
  • * Must be able to complete neurocognitive assessments on a handheld computer.
  • * Diagnosed with Diabetes
  • * Contraindication to Jardiance/Entresto or any heart failure medication (per guideline-directed therapy, 2022).
  • * Previous therapy with Jardiance at \<4 weeks
  • * Glomerular Filtration Rate \<20
  • * Pregnancy, breastfeeding, or planning to become pregnant in the coming year
  • * History of liver disease - including non-alcoholic fatty liver disease (NAFLD) and cirrhosis
  • * History of inborn error(s) of metabolism (including but is not exclusive of Glycogen storage disease type 1)
  • * Glucose-galactose malabsorption, familial hyperinsulinism, maple syrup urine disease,
  • * Gaucher disease,
  • * Tay-Sachs disease,
  • * Mucolipidosis IV,
  • * Niemann-Pick disease,
  • * Type A mitochondrial disease,
  • * Metabolic disorders related to glucose metabolism

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Anita Saraf,

Anita Saraf, MD, PhD, PRINCIPAL_INVESTIGATOR, Assistant Professor

Study Record Dates

2027-06-01