Using sacubitril/valsartan to prevent atrial fibrillation recurrence in elderly patients after heart procedure

Sacubitril Valsartan in Preventing the Recurrence of Atrial Fibrillation After Ablation in Elderly Hypertensive Patients with Atrial Fibrillation

This study tests if a heart medication called sacubitril/valsartan can help older patients who have had a heart procedure avoid having atrial fibrillation come back.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 320 (estimated)
• Ages: 55 Years to 80 Years
• Sex: All
• Sponsor: Shanghai Jiao Tong University School of Medicine (Academic / other)
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT05528419 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of sacubitril/valsartan in preventing the recurrence of atrial fibrillation in elderly hypertensive patients who have undergone catheter ablation. The study involves a 12-month prospective, randomized, active-controlled, open-label design with two treatment groups: one receiving sacubitril/valsartan and the other receiving valsartan. Participants will be men and women aged 55 to 80 with specific blood pressure criteria, and they will be monitored for atrial fibrillation recurrence post-ablation. The trial aims to provide insights into improved management strategies for atrial fibrillation in this patient population.

Who should consider this trial

Good fit: Ideal candidates are elderly patients aged 55 to 80 with persistent or paroxysmal atrial fibrillation who are scheduled for catheter ablation and have hypertension.

Not a fit: Patients with secondary hypertension, severe heart conditions, or significant renal or hepatic dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the recurrence of atrial fibrillation in elderly patients, improving their quality of life and reducing associated health risks.

How similar studies have performed: Other studies have shown promise in using similar approaches for managing atrial fibrillation, but this specific combination is being evaluated for the first time in this demographic.

Eligibility criteria

Inclusion Criteria:

1. Aged 55-80;
2. Persistent ot paroxysmal atrial fibrillation patients who are going to receive catheter ablation surgery;
3. Clinic systolic blood pressure (SBP) ≥ 130 or diastolic blood pressure (DBP) ≥ 80 mmHg) in untreated and treated patients；
4. Ability to understand the study requirements and provide informed consent.

Exclusion Criteria:

1. Secondary hypertension;
2. Clinic SBP/DBP≥180/110 mmHg, or 24-h ambulatory mean SBP/DBP\<120/70 mmHg;
3. Coronary heart disease, valvular heart disease, hypertrophic cardiomyopathy, pulmonary heart disease, hyperthyroidism or hypothyroidism;
4. New York Heart Association functional class IV, or left ventricular ejection fraction of \<30%;
5. Implanted pacemaker or defibrillator, myocardial infarction or percutaneous coronary intervention of ≤ 6 months before ablation;
6. Presence of LA thrombus on transesophageal echocardiography;
7. Severe hepatic or severe renal dysfunction estimated glomerular filtration rate of \< 30 mL/min\*per1.73 m2;
8. Serum potassium \>5.5 mmol/L;
9. Pregnant or lactating women;
10. Other circumstances that patients are not appropriate for the study upon the investigator's judgment;
11. Patients who are receiving other study drugs or study medical devices;
12. Unwilling or unable to provide informed consent.

Where this trial is running

Shanghai, Shanghai

• Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai, China (Recruiting)

Conditions Atrial Fibrillation Recurrent; Hypertension; elderly; ablation; blood pressure