Complex Congenital Heart DiseaseISACCNCT06149806
National Registry of Adult Heart Failure Patients With Complex Congenital Heart Disease: Systemic Right Ventricle and Single Ventricle Treated With Sacubitril/Valsartan
An observational study of Complex Congenital Heart Disease, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Heart failure in adults with congenital heart disease is a major cause of morbidity and mortality. Patients with systemic right ventricle (SRV) and single ventricle (SV) are particularly at risk1, 2, 3. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complex Congenital Heart Disease
- What is being tested?
- Sacubitril / Valsartan Oral Tablet [Entresto]
- Type of treatment
- Pill or oral medicine
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2021to 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 Congenital heart disease with systemic right ventricle or unique ventricle.
Who may be able to join
- - Patients ≥ 18 years of age
- Congenital heart disease with systemic right ventricle (D-TGV after atrial switch (Mustard or Senning surgery) or double mismatch), single ventricle of right or left morphology
- Systemic ventricular ejection fraction ≤ 40% (on cardiac magnetic resonance imaging (MRI) less than 12 months old).
- In case of contraindication to MRI, LVEF ≤ 40% if systemic left ventricle or surface shortening fraction ≤ 35% if VDS12 (examination less than 12 months old).
- NYHA II or III
- On optimal heart failure therapy: ACE inhibitor or ARB2 for ≥ 4 weeks, at maximum tolerated dose. Whether or not combined with beta-blockers and maximum-tolerated-dose mineralocorticoid receptor antagonists.
- Cardiopulmonary exercise test (CPET) within the last 12 months
Who cannot join
- - Other congenital heart disease
- Inability to perform CPETH
- Immuno-allergic reaction, history of angioedema on ACE inhibitors or ARB2 inhibitors
- Symptomatic arterial hypotension or BPs < 100 mHg
- Renal insufficiency (GFR <30 mL/min/m²), hyperkalemia > 5.4 mmol/l, severe hepatic insufficiency (Child-Pugh Class C)
- Pregnancy or breast-feeding
- Opposition to use of patient data
- Type 1 diabetes if on iSGLT2
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Grenoble Alpes
La Tronche, 38700
Claire Massardier, cmassardier@chu-grenoble.fr
About this study
Heart failure in adults with congenital heart disease is a major cause of morbidity and mortality. Patients with systemic right ventricle (SRV) and single ventricle (SV) are particularly at risk1, 2, 3.
There are no specific recommendations for the management of heart failure in adults with congenital heart disease, whose management is based on "general cardiology" recommendations4,5.
Read more
Sacubitril/Valsartan is validated as a treatment for heart failure in adults with acquired pathological left ventricular dysfunction (left ventricular ejection fraction (LVEF) < 40%, New York Heart Association (NYHA) functional class II and III despite optimal heart failure therapy)7. Although this molecule is used in current practice in patients with congenital heart disease, published data are limited 6-10.
The aim of our work is to describe the efficacy and tolerability of Sacubitril/Valsartan in the treatment of chronic heart failure on VDS and VU through an observational, prospective, multicenter registry.
The latest heart failure treatment guidelines, updated in 202111, recommend the addition of type 2 sodium-glucose co-transport inhibitors in heart failure patients with impaired ejection fraction (class IA recommendation). Two molecules are used in current practice: dapagliflozin and empagliflozin, at a single dosage of 10 mg/day.
We will also be collecting data on the efficacy and safety of iSGLT2. It should be noted that, for practical reasons, there may be a delay between the end of the 1st study period (ISACC1) of one year and the start of the 2nd study period (ISACC2).
Follow-up examinations carried out during the study period will not differ from those currently recommended in current practice5.
- Conditions
- Complex Congenital Heart Disease
- Being tested
- Sacubitril / Valsartan Oral Tablet [Entresto]
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacubitril / Valsartan Oral Tablet [Entresto]Drug
efficacy and tolerability of Sacubitril/Valsartan in the treatment of chronic heart failure on complex congenital cardiopathy
| Study group | Role | What they receive |
|---|---|---|
| efficacy and tolerability of Sacubitril/Valsartan | efficacy and tolerability of Sacubitril/Valsartan in the treatment of chronic heart failure on complex congenital cardiopathy Receives: Drug: Sacubitril / Valsartan Oral Tablet [Entresto] |
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe the 12-month (± 2 months) evolution of functional capacity during CPETH in adult heart failure patients with dysfunctional VDS or VU treated with Sacubitril/Valsartan.
Comparison of peak VO2 during CPETH before introduction of Sacubitril/Valsartan and at 12 months.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start1 Jul 2021
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06149806
- Sponsor's protocol ID
- 38RC21.003
- Acronym
- ISACC
- Status last verified
- Nov 2023
- First submitted
- 20 Nov 2023
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Registry of Adult Heart Failure Patients With Complex Congenital Heart Disease: Systemic Right Ventricle and Single Ventricle Treated With Sacubitril/Valsartan
- ClinicalTrials.gov ID
- NCT06149806
- Acronym / sponsor ID
- ISACC / 38RC21.003
- Conditions
- Complex Congenital Heart Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 29 Nov 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 in adults with congenital heart disease is a major cause of morbidity and mortality. Patients with systemic right ventricle (SRV) and single ventricle (SV) are particularly at risk1, 2, 3.
There are no specific recommendations for the management of heart failure in adults with congenital heart disease, whose management is based on "general cardiology" recommendations4,5.
Sacubitril/Valsartan is validated as a treatment for heart failure in adults with acquired pathological left ventricular dysfunction (left ventricular ejection fraction (LVEF) < 40%, New York Heart Association (NYHA) functional class II and III despite optimal heart failure therapy)7. Although this molecule is used in current practice in patients with congenital heart disease, published data are limited 6-10.
The aim of our work is to describe the efficacy and tolerability of Sacubitril/Valsartan in the treatment of chronic heart failure on VDS and VU through an observational, prospective, multicenter registry.
The latest heart failure treatment guidelines, updated in 202111, recommend the addition of type 2 sodium-glucose co-transport inhibitors in heart failure patients with impaired ejection fraction (class IA recommendation). Two molecules are used in current practice: dapagliflozin and empagliflozin, at a single dosage of 10 mg/day.
We will also be collecting data on the efficacy and safety of iSGLT2. It should be noted that, for practical reasons, there may be a delay between the end of the 1st study period (ISACC1) of one year and the start of the 2nd study period (ISACC2).
Follow-up examinations carried out during the study period will not differ from those currently recommended in current practice5.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| efficacy and tolerability of Sacubitril/Valsartan | – | Drug: Sacubitril / Valsartan Oral Tablet [Entresto]efficacy and tolerability of Sacubitril/Valsartan in the treatment of chronic heart failure on complex congenital cardiopathy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with Congenital heart disease with systemic right ventricle or unique ventricle.
Key inclusion criteria (7 listed)
- - Patients ≥ 18 years of age
- Congenital heart disease with systemic right ventricle (D-TGV after atrial switch (Mustard or Senning surgery) or double mismatch), single ventricle of right or left morphology
- Systemic ventricular ejection fraction ≤ 40% (on cardiac magnetic resonance imaging (MRI) less than 12 months old).
- In case of contraindication to MRI, LVEF ≤ 40% if systemic left ventricle or surface shortening fraction ≤ 35% if VDS12 (examination less than 12 months old).
- NYHA II or III
Key exclusion criteria (8 listed)
- - Other congenital heart disease
- Inability to perform CPETH
- Immuno-allergic reaction, history of angioedema on ACE inhibitors or ARB2 inhibitors
- Symptomatic arterial hypotension or BPs < 100 mHg
- Renal insufficiency (GFR <30 mL/min/m²), hyperkalemia > 5.4 mmol/l, severe hepatic insufficiency (Child-Pugh Class C)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacubitril / Valsartan Oral Tablet [Entresto]efficacy and tolerability of Sacubitril/Valsartan in the treatment of chronic heart failure on complex congenital cardiopathy | Drug | efficacy and tolerability of Sacubitril/Valsartan |
Primary outcome
To describe the 12-month (± 2 months) evolution of functional capacity during CPETH in adult heart failure patients with dysfunctional VDS or VU treated with Sacubitril/Valsartan.
Time frame: 12 months
Comparison of peak VO2 during CPETH before introduction of Sacubitril/Valsartan and at 12 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Individual participant dataSharing planned: Undecided
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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 Complex Congenital Heart Disease, run by University Hospital, Grenoble 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 7 inclusion and 8 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 29 Nov 2023. 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 Claire Massardier, MD (0476768888, cmassardier@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To describe the 12-month (± 2 months) evolution of functional capacity during CPETH in adult heart failure patients with dysfunctional VDS or VU treated with Sacubitril/Valsartan. (time frame: 12 months). 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 29 Nov 2023.