Heart FailureGACHNCT05897489
SGLT2 for Heart Failure in CHD Patients
An observational study of Heart Failure, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Heart failure (HF) in adult patients with congenital heart disease is a major cause of morbidity and mortality. Approximately 30% of patients with significant congenital heart disease will develop signs of heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 11 Dec 2023to 25 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Adults with heart failure and congenital heart disease
Who may be able to join
- Patients ≥ 18 years of age
- Congenital heart disease (repaired, unrepaired, or palliated) with clinical heart failure NYHA class II, III, or IV at the time of SGLT2i initiation B59
- Patient in whom SGLT2i therapy has been started within the previous 12 months or is started at the time of the visit.
- Registered to the French social security system
Who cannot join
- Opposition of the patient to the use of his/her data
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University hospital of Nice
Nice, 06100
Pamela MOCERI
About this study
Official title: SGLT2 Inhibitors in Adult Patients With Heart Failure Related to Congenital Heart Disease
Heart failure (HF) in adult patients with congenital heart disease is a major cause of morbidity and mortality. Approximately 30% of patients with significant congenital heart disease will develop signs of heart failure. Heart failure leads to hospitalization and disability with a longer hospital stay and higher health care costs as compared to heart failure patients without congenital heart disease. One-third of deaths in patients with congenital heart disease are attributable to heart failure.
In patients with heart failure and reduced ejection fraction (EF), 2021 ESC recommendations suggest the use of sodium-glucose co-transporter 2 inhibitors (SGLT2i) (dapaglifozin and empaglifozin), a new therapeutic class for heart failure (HF), in a class IA recommendation. In addition to reduced EF, these molecules have shown efficacy in preserved EF, leading to their reimbursement in both preserved and reduced ejection fraction in France.
Read more
Unfortunately, given the relatively low number of HF-congenital heart disease, patients, they were not included in previous studies. However, the seriousness of their condition and the absence of therapeutic explain the prescription of SGLT2i in those patients and the likelihood of increased use in the future. This especially underlines the need for safety data in this real-world population.
To date, no data on the safety or efficacy of SGLT2i in HF-congenital heart disease have been published. The results of this study would provide reassurance about the safety of SGLT2i in adult congenital patients and potentially expand the indication of SGLT2i in HF related to congenital heart disease
The objective of this study is to assess on real-life data, through a multicenter registry:
- The efficacy of SGLT2i in patients with heart failure related to congenital heart disease - The indications of SGLT2i use (type of congenital heart disease)
- The safety of SGLT2i (collection of adverse events)
- Conditions
- Heart Failure
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate, on real-life data, the efficacy of iSGLT2 in patients with heart failure related to congenital heart disease as defined by improvement in NYHA class and/or change in NT-proBNP.
Efficacy of SGLT2i therapy will be assessed by a composite endpoint including NT-proBNP and NYHA class. Thus, a patient with any improvement (decrease) in the biomarker (NT-proBNP) and/or improvement in at least 1 NYHA class will be defined as successful with SGLT2i therapy. The success rate in the target population will be calculated at the end of the study follow-up
Measured: 6 to 12 months after SGLT2i introduction
Secondary outcomes (4)
To describe the population of adults with congenital heart disease on SGLT2i prescription
The study population will be described by the history of the disease in particular duration of the evolution of the CI
Measured: 6-12 months after SGLT2i introduction
To compare the evolution of biological stress test parameters of SGLT2i in patients with heart failure related to congenital heart disease treated with iSGLT2.
The evolution of the following efficacy parameters between baseline and M6/M12 will be studied : biological parameters (Plasma creatinine at T0 and 6-12 months, Kalemia at T0 and 6-12 months)
Measured: 6-12 months after SGLT2i introduction
Incidence of Treatment-Emergent Adverse Event in patients with heart failure related to congenital heart disease.[Safety and Tolerability]
Tolerance will be studied through the collection of the following adverse events:
arterial hypotension (BP will be recorded at M0, M6 and M12), hyperkalemia, acute renal failure, recurrent urinary tract infections, ketoacidosis (Discontinuation of treatment for AEs, Cardiovascular hospitalization during the study period, Cardiac transplantation or ventricular assist during the study period)
Measured: 6-12 months after SGLT2i introduction
To evaluate the overall survival of heart failure related to congenital heart disease patients on SGLT2i after 12 months
Overall survival will be assessed at 6 months and 12 months after initiation of treatment. Survival time will be defined as the time in months from initiation of glifozine to death from any cause. Patients who discontinue follow-up before the end of the study follow-up period will be censored at the time of last report.
Measured: 6-12 months after SGLT2i introduction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start11 Dec 2023
- Primary completion25 Dec 2024 (estimated)
- Study completion25 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05897489
- Sponsor's protocol ID
- 23Cardio01
- Acronym
- GACH
- Status last verified
- May 2024
- First submitted
- 26 May 2023
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SGLT2 Inhibitors in Adult Patients With Heart Failure Related to Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT05897489
- Acronym / sponsor ID
- GACH / 23Cardio01
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- 25 Dec 2024 (estimated)
- Study completion
- 25 Dec 2025 (estimated)
- First posted
- 9 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Heart failure (HF) in adult patients with congenital heart disease is a major cause of morbidity and mortality. Approximately 30% of patients with significant congenital heart disease will develop signs of heart failure. Heart failure leads to hospitalization and disability with a longer hospital stay and higher health care costs as compared to heart failure patients without congenital heart disease. One-third of deaths in patients with congenital heart disease are attributable to heart failure.
In patients with heart failure and reduced ejection fraction (EF), 2021 ESC recommendations suggest the use of sodium-glucose co-transporter 2 inhibitors (SGLT2i) (dapaglifozin and empaglifozin), a new therapeutic class for heart failure (HF), in a class IA recommendation. In addition to reduced EF, these molecules have shown efficacy in preserved EF, leading to their reimbursement in both preserved and reduced ejection fraction in France.
Unfortunately, given the relatively low number of HF-congenital heart disease, patients, they were not included in previous studies. However, the seriousness of their condition and the absence of therapeutic explain the prescription of SGLT2i in those patients and the likelihood of increased use in the future. This especially underlines the need for safety data in this real-world population.
To date, no data on the safety or efficacy of SGLT2i in HF-congenital heart disease have been published. The results of this study would provide reassurance about the safety of SGLT2i in adult congenital patients and potentially expand the indication of SGLT2i in HF related to congenital heart disease
The objective of this study is to assess on real-life data, through a multicenter registry:
- The efficacy of SGLT2i in patients with heart failure related to congenital heart disease - The indications of SGLT2i use (type of congenital heart disease)
- The safety of SGLT2i (collection of adverse events)
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with heart failure and congenital heart disease
Key inclusion criteria (4 listed)
- Patients ≥ 18 years of age
- Congenital heart disease (repaired, unrepaired, or palliated) with clinical heart failure NYHA class II, III, or IV at the time of SGLT2i initiation B59
- Patient in whom SGLT2i therapy has been started within the previous 12 months or is started at the time of the visit.
- Registered to the French social security system
Key exclusion criteria (1 listed)
- Opposition of the patient to the use of his/her data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate, on real-life data, the efficacy of iSGLT2 in patients with heart failure related to congenital heart disease as defined by improvement in NYHA class and/or change in NT-proBNP.
Time frame: 6 to 12 months after SGLT2i introduction
Efficacy of SGLT2i therapy will be assessed by a composite endpoint including NT-proBNP and NYHA class. Thus, a patient with any improvement (decrease) in the biomarker (NT-proBNP) and/or improvement in at least 1 NYHA class will be defined as successful with SGLT2i therapy. The success rate in the target population will be calculated at the end of the study follow-up
4 secondary outcomes
To describe the population of adults with congenital heart disease on SGLT2i prescription
Time frame: 6-12 months after SGLT2i introduction
To compare the evolution of biological stress test parameters of SGLT2i in patients with heart failure related to congenital heart disease treated with iSGLT2.
Time frame: 6-12 months after SGLT2i introduction
Incidence of Treatment-Emergent Adverse Event in patients with heart failure related to congenital heart disease.[Safety and Tolerability]
Time frame: 6-12 months after SGLT2i introduction
To evaluate the overall survival of heart failure related to congenital heart disease patients on SGLT2i after 12 months
Time frame: 6-12 months after SGLT2i introduction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pamela MOCERI (0492037733 ext. +33, moceri.p@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate, on real-life data, the efficacy of iSGLT2 in patients with heart failure related to congenital heart disease as defined by improvement in NYHA class and/or change in NT-proBNP. (time frame: 6 to 12 months after SGLT2i introduction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.