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Treatment of Hypertension with or without Sacubitril/Valsartan on the AF Recurrent Rate of Catheter Ablation in Patients with Persistent Atrial Fibrillation and Essential Hypertension

Treatment of Hypertension with or without Sacubitril/Valsartan on the AF Recurrent Rate of Catheter Ablation in Patients with Persistent Atrial Fibrillation and Essential Hypertension

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200067236
Enrollment
Unknown
Registered
2022-12-30
Start date
2023-01-01
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atrial fibrillation

Interventions

Sacubatril/valsartan antihypertensive therapy group (experimental group):Antihypertensive regimen: based on sacubitril/valsartan, CCB, diuretics, ß blockers, and a blockers can be combined as needed
No sacubitril/valsartan antihypertensive therapy group (control group):Can be combined with CCBs, diuretics, ß blockers, a blockers (subgroup 1)
If blood pressure is still not controlled, ACE-I or ARB (excluding sacubitril/valsartan or valsartan) can be combined (subgroup 2)

Sponsors

Fujian Medical University Union Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years; 2. Symptomatic persistent atrial fibrillation complicated with essential hypertension failed to be treated with at least one antiarrhythmic drug, and catheter ablation was proposed for the first time. 3. Voluntarily submit to all follow-up evaluations required by the program; 4. The subject (or legal guardian) understands the test requirements and treatment procedures and signs a written informed consent prior to performing the tests or procedures specified in the protocol.

Exclusion criteria

Exclusion criteria: 1. Patients were allergic to Shakubactril/valsartan; 2. Obvious hematopoietic system abnormalities, such as platelet count 700x10^9/L; White blood cell count = 3 times the upper limit of normal); 5. Suffering from serious diseases with a life expectancy of less than 12 months, such as cancer, other advanced diseases, etc.; 6. Pregnant patients and patients planning pregnancy; 7. Patients who failed to complete the ablation due to severe intraoperative complications, such as acute cardiac tamponage and pneumothorax; 8. Are participating in a clinical trial of another drug or device that has not met its primary endpoint, or plan to participate in a clinical trial of another drug or device within 12 months after surgery.

Design outcomes

Primary

MeasureTime frame
Recurrence rates of atrial fibrillation and/or atrial flutter during the 12-month follow-up period following catheter ablation;

Secondary

MeasureTime frame
Cumulative incidence of major adverse cardiovascular events (MACEs) at 12 months postoperatively, including cardiac death, myocardial infarction, ischaemic and/or hemorrhagic stroke, acute heart failure, or worsening heart failure hospitalization;Attainment rate for hypertension treatment;Incidence of hyperkalemia;

Countries

China

Contacts

Public ContactChen Jianhua

Fujian Medical University Union Hospital

jianhuacheny@sina.cn+86 13365910985

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026