RECRUITING

Adult Congenital Heart Disease International EValuation of the Effectiveness of SGLT2i Registry

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Conditions

Adult Congenital Heart DiseaseCongenital Heart DiseaseSystemic Right VentricleTransposition of the Great ArteriesCongenitally Corrected Transposition of the Great ArteriesFontanSingle VentricleTetralogy of Fallot (TOF)ACHDCHDsodium-glucose cotransporter 2 inhibitorsSGLT2iSGLT2heart failureHFTGAsRVtetralogy of fallotToF

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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

This real-world, international registry aims to evaluate the current experience with sodium-glucose cotransporter 2 inhibitors (SGLT2i) in adult congenital heart disease (ACHD) patients by investigating the prescription patterns, safety, tolerability, and potential beneficial effects on heart failure-related outcomes.

Official Title

Adult Congenital Heart Disease International EValuation of the Effectiveness of SGLT2i (ACHIEVE-SGLT2i) Registry

Quick Facts

Study Start:2023-01-01
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06932081

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. * Congenital heart defect.
  2. * Age ≥ 18 years.
  3. * Initiated on treatment with an SGLT2i.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Ralph M.L. Neijenhuis, MD
CONTACT
+31 71 5262020
r.m.l.neijenhuis@lumc.nl
Anastasia D. Egorova, MD PhD
CONTACT
+31 71 5262020
a.egorova@lumc.nl

Principal Investigator

Anastasia D. Egorova, MD PhD
PRINCIPAL_INVESTIGATOR
Leiden University Medical Center

Study Locations (Sites)

Johns Hopkins University
Baltimore, Maryland, 21205
United States
Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503
United States
Mount Sinai Fuster Heart Hospital
New York City, New York, 10029
United States

Collaborators and Investigators

Sponsor: Leiden University Medical Center

  • Anastasia D. Egorova, MD PhD, PRINCIPAL_INVESTIGATOR, Leiden University Medical Center

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 Date2023-01-01
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2023-01-01
Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

  • adult congenital heart disease
  • ACHD
  • congenital heart disease
  • CHD
  • sodium-glucose cotransporter 2 inhibitors
  • SGLT2i
  • SGLT2
  • heart failure
  • HF
  • transposition of the great arteries
  • TGA
  • systemic right ventricle
  • sRV
  • Fontan
  • single ventricle
  • tetralogy of fallot
  • ToF

Additional Relevant MeSH Terms

  • Adult Congenital Heart Disease
  • Congenital Heart Disease
  • Systemic Right Ventricle
  • Transposition of the Great Arteries
  • Congenitally Corrected Transposition of the Great Arteries
  • Fontan
  • Single Ventricle
  • Tetralogy of Fallot (TOF)