Angiotensin Receptor-Neprilysin Inhibitor After Transcatheter Aortic Valve Implantation

• Status: Not yet recruiting
• Trial end date: 2026-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this trial is to determine whether the initiation of angiotensin receptor-neprilysin inhibitor (ARNI; sacubitril/valsartan) therapy is safe and effective for improvement of clinical outcome and reversal of adverse cardiac remodeling among patients who underwent TAVI as compared with the standard-of-care therapy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duk-Woo Park, MD
• Collaborators: CardioVascular Research Foundation, Korea; Daewoong Pharmaceutical Co. LTD.
• Treatments: Angiotensin-Converting Enzyme Inhibitors; Antihypertensive Agents

Criteria

Inclusion Criteria:

1. Patients aged ≥60 with symptomatic AS who underwent successful TAVI (either native valve or valve in valve with any approved/marketed device).

2. Patients who voluntarily participated in the written agreement

Exclusion Criteria:

1. Symptomatic persistent hypotension, systolic blood pressure (SBP) < 100 mm Hg at screening

2. Renal insufficiency: estimated glomerular filtration rate (eGFR) <30 ml/min/1.73 m2 of body-surface area

3. Serum potassium level >5.2 mmol per liter at screening

4. A history of angioedema or unacceptable side effects during receipt of ACE inhibitors or ARBs.

5. Any known or suspected malignancy

6. Subjects with non-cardiac co-morbidities with a life expectancy of less than 12 months

7. Participation in another clinical trials