Atrial Fibrillation (Persistent)Phase 4SUPERIOR 2NCT07910058
Sacubitril/Valsartan vs Standard Treatment for Preventing Atrial Fibrillation Recurrence After Catheter Ablation in Persistent Atrial Fibrillation Patients With Without Hypertension
A Phase 4 study testing Sacubitril/Valsartan in people with Atrial Fibrillation (Persistent) and Catheter Ablation, run by Ruijin Hospital.
Trial summary
The goal of this clinical trial is to investigate the efficacy and safety of angiotensin receptor-neprilysin inhibitor (sacubitril/valsartan) in preventing recurrence of atrial fibrillation after catheter ablation in non-hypertensive patients with persistent atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Atrial Fibrillation (Persistent), Catheter Ablation, Non-hypertension
- What is being tested?
- Sacubitril/Valsartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 472 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2026to 30 Jun 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent obtained prior to any study procedure.
- Age between 18 and 79 years, male or female.
- Diagnosis of persistent non-valvular atrial fibrillation scheduled for first catheter ablation..
- Baseline mean office blood pressure in the non-hypertensive category: Non-elevated BP (100/55 to 120/70 mmHg without antihypertensive drugs) OR Elevated BP (SBP 120-139 mmHg or DBP 70-89 mmHg).
- Left ventricular ejection fraction (LVEF) ≥ 40% by echocardiography.
- Willingness and ability to comply with scheduled visits and study procedures.
Who cannot join
- Diagnosed secondary hypertension or hypertension (mean office blood pressure ≥140/90 mmHg or taking ≥2 antihypertensive drugs).
- History of symptomatic hypotension, or baseline SBP <100 mmHg.
- Valvular atrial fibrillation (moderate-to-severe mitral stenosis or regurgitation, or mechanical heart valves), cardiomyopathy, cor pulmonale, or coexisting hyperthyroidism or hypothyroidism.
- Left atrial anteroposterior diameter >55 mm.
- New York Heart Association (NYHA) functional class IV heart failure, or LVEF < 40%.
- Major cardiovascular events or cerebrovascular diseases within 3 months prior to ablation..
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- Acute/severe systemic infection within 1 month prior to ablation, or left atrial/appendage thrombus.
- Hepatic or renal impairment, defined as alanine aminotransferase or aspartate aminotransferase levels >2 times the upper limit of normal, or estimated glomerular filtration rate <30 mL/min/1.73 m2.
- Serum potassium >5.5 mmol/L.
- Pregnant or breastfeeding women, psychiatric disorders, or participation in other clinical trials.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Sacubitril/Valsartan for Preventing the Recurrence of Atrial Fibrillation After Catheter Ablation in Non-hypertensive Patients With Persistent Atrial Fibrillation: A Multicenter, Randomized Controlled Trial
The goal of this clinical trial is to investigate the efficacy and safety of angiotensin receptor-neprilysin inhibitor (sacubitril/valsartan) in preventing recurrence of atrial fibrillation after catheter ablation in non-hypertensive patients with persistent atrial fibrillation.
This is a multicenter, randomized, open-label, parallel-group study in participants aged 18 to 79 years old who are hospitalized for planned catheter ablation of persistent atrial fibrillation and have a mean clinic blood pressure between 100/55 mmHg and 139/89 mmHg. The main questions it aims to answer are:
Read more
- Does sacubitril/valsartan lower the proportion of late atrial tachyarrhythmia recurrence after catheter ablation in non-hypertensive patients with persistent AF?
- How safe is sacubitril/valsartan in people with persistent atrial fibrillation who do not have hypertension? Researchers will compare sacubitril/valsartan with standard care (routine post-ablation care without ACE inhibitors, ARBs, or ARNI) to see if sacubitril/valsartan prevents AF recurrence after ablation.
Participants will:
- Be randomly assigned after ablation to receive sacubitril/valsartan or standard care.
- Receive the assigned treatment and be followed for up to 12 months.
- Attend clinic visits and tests to check for recurrent atrial arrhythmia and for safety.
- Give blood samples before treatment and after 12 months of treatment for exploring potential molecular mechanisms.
- Conditions
- Atrial Fibrillation (Persistent), Catheter Ablation, Non-hypertension, Angiotensin Receptor/Neprilysin Inhibitor
- Being tested
- Sacubitril/Valsartan, Standard Care
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacubitril/ValsartanDrug
50 mg twice daily (b.i.d.) for 12 months.
Standard CareOther
Routine post-ablation care without ACEI/ARB/ARNI drugs.
| Study group | Role | What they receive |
|---|---|---|
| Sacubitril/Valsartan Group | Experimental | Participants receive sacubitril/valsartan 50mg b.i.d. for 12 months. Receives: Drug: Sacubitril/Valsartan |
| Standard Care Group | Other | Participants receive standard post-ablation care without ACEI/ARB/ARNI. Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in the proportion of late atrial tachyarrhythmia recurrence between the two treatment groups.
Late atrial tachyarrhythmia recurrence is defined as any documented episode of atrial fibrillation, atrial flutter, or atrial tachycardia lasting more than 30 seconds, detected by single-lead electrocardiography (ECG), 12-lead ECG, or 24-hour Holter monitoring during the follow-up period from 3 to 12 months.
Measured: Between 3 and 12 months after catheter ablation.
Secondary outcomes (6)
The difference in the proportion of early atrial tachyarrhythmia recurrence between the two treatment groups.
Early recurrent atrial arrhythmia is defined as documented atrial fibrillation, atrial flutter, or atrial tachycardia lasting >30 seconds detected by ECG or Holter monitoring from day 2 to 3 months post-ablation.
Measured: From day 2 to 3 months post-ablation
Changes in office and 24-hour ambulatory blood pressure from baseline to 12 months.
Measured: Baseline and 12 months
Changes in NT-proBNP from baseline to 12 months.
Measured: Baseline and 12 months
Changes in left atrial global longitudinal strain from baseline to 12 months.
Measured by echocardiography
Measured: Baseline and 12 months
Changes in atrial fibrosis imaging in the CMR or [68Ga]FAPI-PET-CMR sub-cohort from baseline to 12 months.
Quantified by late gadolinium enhancement cardiac magnetic resonance (LGE-CMR) or [68Ga]FAPI 04-PET/MRI imaging.
Measured: Baseline and 12 months
Composite cardiovascular outcomes, including fatal and non-fatal stroke, acute myocardial infarction, and cardiovascular death during 12 months of follow-up.
Includes fatal and non-fatal stroke, acute myocardial infarction, and cardiovascular death.
Measured: From randomization up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start31 Oct 2026 (estimated)
- Primary completion31 Mar 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation (Persistent)Studies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 472 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JIN QI, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07910058
- Sponsor's protocol ID
- 2026749
- Acronym
- SUPERIOR 2
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A decision on whether to share individual participant data (IPD) has not yet been made. The investigators will consider data sharing after the primary results are published. Any future sharing will be subject to institutional policies, ethical approval, and a signed data use agreement.
Publications
Wang JG, Zhang W, Li Y, Liu L. Hypertension in China: epidemiology and treatment initiatives. Nat Rev Cardiol. 2023 Aug;20(8):531-545. doi: 10.1038/s41569-022-00829-z. Epub 2023 Jan 11.
PubMed 36631532McMurray JJ, Packer M, Desai AS, Gong J, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Solomon SD, Swedberg K, Zile MR; PARADIGM-HF Investigators and Committees. Angiotensin-neprilysin inhibition versus enalapril in heart failure. N Engl J Med. 2014 Sep 11;371(11):993-1004. doi: 10.1056/NEJMoa1409077. Epub 2014 Aug 30.
PubMed 25176015Verdecchia P, Angeli F, Reboldi G. Hypertension and Atrial Fibrillation: Doubts and Certainties From Basic and Clinical Studies. Circ Res. 2018 Jan 19;122(2):352-368. doi: 10.1161/CIRCRESAHA.117.311402.
PubMed 29348255McEvoy JW, McCarthy CP, Bruno RM, Brouwers S, Canavan MD, Ceconi C, Christodorescu RM, Daskalopoulou SS, Ferro CJ, Gerdts E, Hanssen H, Harris J, Lauder L, McManus RJ, Molloy GJ, Rahimi K, Regitz-Zagrosek V, Rossi GP, Sandset EC, Scheenaerts B, Staessen JA, Uchmanowicz I, Volterrani M, Touyz RM; ESC Scientific Document Group. 2024 ESC Guidelines for the management of elevated blood pressure and hypertension. Eur Heart J. 2024 Oct 7;45(38):3912-4018. doi: 10.1093/eurheartj/ehae178. No abstract available.
PubMed 39210715Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL; ESC Scientific Document Group. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021 Feb 1;42(5):373-498. doi: 10.1093/eurheartj/ehaa612. No abstract available.
PubMed 32860505
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sacubitril/Valsartan for Preventing the Recurrence of Atrial Fibrillation After Catheter Ablation in Non-hypertensive Patients With Persistent Atrial Fibrillation: A Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07910058
- Acronym / sponsor ID
- SUPERIOR 2 / 2026749
- Conditions
- Atrial Fibrillation (Persistent), Catheter Ablation, Non-hypertension, Angiotensin Receptor/Neprilysin Inhibitor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 472 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 2 Nov 2026 (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.
The goal of this clinical trial is to investigate the efficacy and safety of angiotensin receptor-neprilysin inhibitor (sacubitril/valsartan) in preventing recurrence of atrial fibrillation after catheter ablation in non-hypertensive patients with persistent atrial fibrillation.
This is a multicenter, randomized, open-label, parallel-group study in participants aged 18 to 79 years old who are hospitalized for planned catheter ablation of persistent atrial fibrillation and have a mean clinic blood pressure between 100/55 mmHg and 139/89 mmHg. The main questions it aims to answer are:
- Does sacubitril/valsartan lower the proportion of late atrial tachyarrhythmia recurrence after catheter ablation in non-hypertensive patients with persistent AF?
- How safe is sacubitril/valsartan in people with persistent atrial fibrillation who do not have hypertension? Researchers will compare sacubitril/valsartan with standard care (routine post-ablation care without ACE inhibitors, ARBs, or ARNI) to see if sacubitril/valsartan prevents AF recurrence after ablation.
Participants will:
- Be randomly assigned after ablation to receive sacubitril/valsartan or standard care.
- Receive the assigned treatment and be followed for up to 12 months.
- Attend clinic visits and tests to check for recurrent atrial arrhythmia and for safety.
- Give blood samples before treatment and after 12 months of treatment for exploring potential molecular mechanisms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sacubitril/Valsartan Group | Experimental | Drug: Sacubitril/ValsartanParticipants receive sacubitril/valsartan 50mg b.i.d. for 12 months. |
| Standard Care Group | Other | Other: Standard CareParticipants receive standard post-ablation care without ACEI/ARB/ARNI. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent obtained prior to any study procedure.
- Age between 18 and 79 years, male or female.
- Diagnosis of persistent non-valvular atrial fibrillation scheduled for first catheter ablation..
- Baseline mean office blood pressure in the non-hypertensive category: Non-elevated BP (100/55 to 120/70 mmHg without antihypertensive drugs) OR Elevated BP (SBP 120-139 mmHg or DBP 70-89 mmHg).
- Left ventricular ejection fraction (LVEF) ≥ 40% by echocardiography.
Key exclusion criteria (10 listed)
- Diagnosed secondary hypertension or hypertension (mean office blood pressure ≥140/90 mmHg or taking ≥2 antihypertensive drugs).
- History of symptomatic hypotension, or baseline SBP <100 mmHg.
- Valvular atrial fibrillation (moderate-to-severe mitral stenosis or regurgitation, or mechanical heart valves), cardiomyopathy, cor pulmonale, or coexisting hyperthyroidism or hypothyroidism.
- Left atrial anteroposterior diameter >55 mm.
- New York Heart Association (NYHA) functional class IV heart failure, or LVEF < 40%.
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/Valsartan50 mg twice daily (b.i.d.) for 12 months. | Drug | Sacubitril/Valsartan Group |
| Standard CareRoutine post-ablation care without ACEI/ARB/ARNI drugs. | Other | Standard Care Group |
Primary outcome
The difference in the proportion of late atrial tachyarrhythmia recurrence between the two treatment groups.
Time frame: Between 3 and 12 months after catheter ablation.
Late atrial tachyarrhythmia recurrence is defined as any documented episode of atrial fibrillation, atrial flutter, or atrial tachycardia lasting more than 30 seconds, detected by single-lead electrocardiography (ECG), 12-lead ECG, or 24-hour Holter monitoring during the follow-up period from 3 to 12 months.
6 secondary outcomes
The difference in the proportion of early atrial tachyarrhythmia recurrence between the two treatment groups.
Time frame: From day 2 to 3 months post-ablation
Changes in office and 24-hour ambulatory blood pressure from baseline to 12 months.
Time frame: Baseline and 12 months
Changes in NT-proBNP from baseline to 12 months.
Time frame: Baseline and 12 months
Changes in left atrial global longitudinal strain from baseline to 12 months.
Time frame: Baseline and 12 months
Changes in atrial fibrosis imaging in the CMR or [68Ga]FAPI-PET-CMR sub-cohort from baseline to 12 months.
Time frame: Baseline and 12 months
Composite cardiovascular outcomes, including fatal and non-fatal stroke, acute myocardial infarction, and cardiovascular death during 12 months of follow-up.
Time frame: From randomization up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Results publication: PubMed 36631532Wang JG, Zhang W, Li Y, Liu L. Hypertension in China: epidemiology and treatment initiatives. Nat Rev Cardiol. 2023 Aug;20(8):531-545. doi: 10.1038/s41569-022-00829-z. Epub 2023 Jan 11.
- Results publication: PubMed 25176015McMurray JJ, Packer M, Desai AS, Gong J, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Solomon SD, Swedberg K, Zile MR; PARADIGM-HF Investigators and Committees. Angiotensin-neprilysin inhibition versus enalapril in heart failure. N Engl J Med. 2014 Sep 11;371(11):993-1004. doi: 10.1056/NEJMoa1409077. Epub 2014 Aug 30.
- Results publication: PubMed 29348255Verdecchia P, Angeli F, Reboldi G. Hypertension and Atrial Fibrillation: Doubts and Certainties From Basic and Clinical Studies. Circ Res. 2018 Jan 19;122(2):352-368. doi: 10.1161/CIRCRESAHA.117.311402.
- Results publication: PubMed 39210715McEvoy JW, McCarthy CP, Bruno RM, Brouwers S, Canavan MD, Ceconi C, Christodorescu RM, Daskalopoulou SS, Ferro CJ, Gerdts E, Hanssen H, Harris J, Lauder L, McManus RJ, Molloy GJ, Rahimi K, Regitz-Zagrosek V, Rossi GP, Sandset EC, Scheenaerts B, Staessen JA, Uchmanowicz I, Volterrani M, Touyz RM; ESC Scientific Document Group. 2024 ESC Guidelines for the management of elevated blood pressure and hypertension. Eur Heart J. 2024 Oct 7;45(38):3912-4018. doi: 10.1093/eurheartj/ehae178. No abstract available.
- Results publication: PubMed 32860505Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL; ESC Scientific Document Group. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021 Feb 1;42(5):373-498. doi: 10.1093/eurheartj/ehaa612. No abstract available.
- Individual participant dataSharing planned: No. A decision on whether to share individual participant data (IPD) has not yet been made. The investigators will consider data sharing after the primary results are published. Any future sharing will be subject to institutional policies, ethical approval, and a signed data use agreement.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sacubitril/Valsartan in people with Atrial Fibrillation (Persistent) and Catheter Ablation, run by Ruijin Hospital.
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 6 inclusion and 10 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: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qi Jin, MD&PhD (86-021-64370045, jinqi127@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in the proportion of late atrial tachyarrhythmia recurrence between the two treatment groups. (time frame: Between 3 and 12 months after catheter ablation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07910058, which also lists 5 linked publications.
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 4 Nov 2026.