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Not yet recruitingNCT07910058SUPERIOR 2Updated Nov 4, 2026

Sacubitril/Valsartan vs Standard Treatment for Preventing Atrial Fibrillation Recurrence After Catheter Ablation in Persistent Atrial Fibrillation Patients With Without Hypertension

A Phase 4 interventional study of Sacubitril/Valsartan and Standard Care in Atrial Fibrillation (Persistent), Catheter Ablation and Non-hypertension, sponsored by Ruijin Hospital. Not yet recruiting. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Ruijin Hospital · Phase 4, Interventional, and Treatment

Updated Nov 4, 2026Eligibility revisedTitle changed+1 moreGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
472
Allocation
Randomized
Ages
18 Years to 79 Years
Sex
All
01

Study 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.

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:

  1. Does sacubitril/valsartan lower the proportion of late atrial tachyarrhythmia recurrence after catheter ablation in non-hypertensive patients with persistent AF?
  2. 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:

  1. Be randomly assigned after ablation to receive sacubitril/valsartan or standard care.
  2. Receive the assigned treatment and be followed for up to 12 months.
  3. Attend clinic visits and tests to check for recurrent atrial arrhythmia and for safety.
  4. Give blood samples before treatment and after 12 months of treatment for exploring potential molecular mechanisms.
02

Conditions studied

  • Atrial Fibrillation (Persistent)
  • Catheter Ablation
  • Non-hypertension
  • Angiotensin Receptor/Neprilysin Inhibitor

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03

In context

Atrial Fibrillation

3,969 studies on the registry are indexed under Atrial Fibrillation; 937 are open to participants now.

This study's planned enrollment of 472 is above the median of 146 across 2,448 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Ruijin Hospital is the lead sponsor of 674 studies on the registry; 382 are open to participants now.

Browse Ruijin Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Nov 4, 2026. See what changed

Ages eligible
18 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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..
  • 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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
472 participants (estimated)

Study arms

  • Experimental
    Sacubitril/Valsartan Group

    Participants receive sacubitril/valsartan 50mg b.i.d. for 12 months.

    Drug: Sacubitril/Valsartan

  • Other
    Standard Care Group

    Participants receive standard post-ablation care without ACEI/ARB/ARNI.

    Other: Standard Care

Interventions

  • DrugSacubitril/Valsartan

    Drug pages: Sacubitril · Valsartan

    50 mg twice daily (b.i.d.) for 12 months.

  • OtherStandard Care

    Routine post-ablation care without ACEI/ARB/ARNI drugs.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Between 3 and 12 months after catheter ablation.

Secondary outcomes

  1. 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.

    Time frame: From day 2 to 3 months post-ablation

  2. Changes in office and 24-hour ambulatory blood pressure from baseline to 12 months.

    Time frame: Baseline and 12 months

  3. Changes in NT-proBNP from baseline to 12 months.

    Time frame: Baseline and 12 months

  4. Changes in left atrial global longitudinal strain from baseline to 12 months.

    Measured by echocardiography

    Time frame: Baseline and 12 months

  5. 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.

    Time frame: Baseline and 12 months

  6. 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.

    Time frame: From randomization up to 12 months

Other outcomes

  1. Incidence of safety endpoints

    Incidence of symptomatic hypotension, renal deterioration, hyperkalemia, and angioedema.

    Time frame: From randomization up to 12 months

  2. Exploratory outcomes: Proteomic and metabolomic profile changes from baseline to 12 months to explore mechanisms and biomarkers.

    Time frame: Baseline and 12 months

07

Study locations

No study locations are listed for this record.

08

References and documents

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 36631532 ↗
  • McMurray 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 25176015 ↗
  • Verdecchia 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 29348255 ↗
  • McEvoy 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 39210715 ↗
  • Hindricks 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 ↗

Individual participant data

Plan to share: 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.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Mar 2029, 29 months later.

Of 128 non-industry phase 4 interventional studies under Atrial Fibrillation, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 81. This study's planned 29 months is below that.

Counting every sponsor, half of 142 studies reached it within 48 months; a quarter within 28 and three quarters within 77.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 26, 2026
First posted
Nov 2, 2026
StartEst.
Oct 31, 2026
Primary completionEst.
Mar 31, 2029
CompletionEst.
Jun 30, 2029
Last update
Nov 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Eligibility
1 inclusion criterion edited; 1 exclusion criterion edited
What changed in the criteria
Inclusion criteria
  • EditedBaseline mean office blood pressure in the non-hypertensive category: Non-elevated BP (100/55 to 120/70 mmHg without antihypertensivesantihypertensive drugs) OR Elevated BP (SBP 120-139 mmHg or DBP 70-89 mmHg).
Exclusion criteria
  • EditedDiagnosed secondary hypertension or hypertension (mean office blood pressure ≥140/90 mmHg or taking ≥2 antihypertensivesantihypertensive drugs).
Nov 4, 2026
Title
An Investigator-initiated, Prospective, Open-label, Multicenter Randomized Controlled Trial, Comparing the Efficacy of Sacubitril/Valsartan andvs Standard Treatment onfor Preventing Atrial Fibrillation Recurrence After Catheter Ablation in Persistent Atrial Fibrillation Patients With Without HypertensiveHypertension
Nov 4, 2026
Registered
First appeared on the registry
Nov 2, 2026
Show all 2 updates
  1. Nov 4, 2026
    Eligibility 1 inclusion criterion edited; 1 exclusion criterion edited
    What changed in the criteria
    Inclusion criteria
    • EditedBaseline mean office blood pressure in the non-hypertensive category: Non-elevated BP (100/55 to 120/70 mmHg without antihypertensivesantihypertensive drugs) OR Elevated BP (SBP 120-139 mmHg or DBP 70-89 mmHg).
    Exclusion criteria
    • EditedDiagnosed secondary hypertension or hypertension (mean office blood pressure ≥140/90 mmHg or taking ≥2 antihypertensivesantihypertensive drugs).
    Title An Investigator-initiated, Prospective, Open-label, Multicenter Randomized Controlled Trial, Comparing the Efficacy of Sacubitril/Valsartan andvs Standard Treatment onfor Preventing Atrial Fibrillation Recurrence After Catheter Ablation in Persistent Atrial Fibrillation Patients With Without HypertensiveHypertension
    + 1 other change: description
  2. Nov 2, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07910058
Lead sponsor
Ruijin Hospital
Responsible party
JIN QI (MD&PhD, Ruijin Hospital) — Principal investigator
First posted
Nov 2, 2026
Start date
Oct 31, 2026 (estimated)
Primary completion
Mar 31, 2029 (estimated)
Completion
Jun 30, 2029 (estimated)
Last update
Nov 4, 2026

Study contacts

Qi Jin, MD&PhD
Contact
jinqi127@163.com
86-021-64370045

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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