Angiotensin-converting enzyme inhibitor for post-transcatheter aortic valve implantation patients: study protocol for a multicenter randomized, open-label blinded endpoint control trial

Abstract

Background With the expanded utilization of transcatheter aortic valve implantation (TAVI) to younger and lower surgical risk patients with severe aortic stenosis (AS), optimal medical therapy after TAVI procedure has become the main concern. Renin-angiotensin system inhibitors (RASi) are widely utilized in the area of cardiovascular disease including heart failure and myocardial infarction and revealed the ability to reverse left ventricular (LV) remodeling. Interests have, thus, been drawn in investigating whether the prescription of RASi after the TAVI procedure can prevent or reverse cardiac remodeling and improve long-term clinical outcomes. No recommendation regarding the prescription of RASi after TAVI is proposed yet due to the lack of evidence from randomized controlled trials, especially in the Chinese population. We, therefore, designed this randomized controlled trial to explore the effect of adding fosinopril to standard care in patients who underwent a successful TAVI procedure on the LV remodeling. Methods A total of 200 post-TAVI patients from seven academic hospitals across China will be recruited and randomized with a ratio of 1:1 to receive standard care or standard care plus fosinopril. Follow-up visits will take place at 30 days, 3 months, 6 months, 12 months, and 24 months from randomization to assess the clinical symptoms, any adverse events, cardiac function, and quality of life. Cardiac magnetic resonance will be performed at baseline and repeated at the 24-month follow-up visit to assess LV remodeling. Discussion This study will provide evidence regarding medical therapy for AS patients who underwent TAVI and filling the gap in the Chinese population. Trial registration Chinese Clinical Trial Registry ChiCTR2100042266. Registered on 17 January 2021

Integrated proteomic and metabolomic profile analyses of cardiac valves revealed molecular mechanisms and targets in calcific aortic valve disease

“…Kininogen 1 was identified as a hub protein based on its highest degree in the PPI network. Angiotensin-converting enzyme (ACE) inhibitors might confer survival benefits in AS by regulating left ventricular remodeling and myocardial fibrosis ( 42 , 43 ). Kininogen 1 is important in ACE-related pathways, and variations in KNG1 correlate with decreased risk of sudden cardiac arrest ( 44 ).…”

The clinical outcomes of reni-angiotensin system inhibitors for patients after transcatheter aortic valve replacement: A systematic review and meta-analysis

“…The potential confounders and bias may exist in included retrospective studies. Some ongoing RCTs including the RASTAVI trial (NCT03201185) and other trials (ChiCTR2100042266, ChiCTR 2100042266) will give us new evidence for this issue ( 37 , 38 ).…”

Transcatheter aortic valve replacement in heart failure

“…Multiple randomized clinical trials are underway assessing the impact of RAS and/or SGLT2 inhibition on left ventricular remodelling and outcomes following TAVR. [78][79][80] Association of beta-blockade with outcomes post-TAVR have also been poorly studied. Approximately one in three patients undergoing TAVR receive beta-blockers.…”

“…Whether inhibition of RAS and sodium–glucose cotransporter 2 (SGLT2) can prevent or reverse left ventricular remodelling post‐TAVR and affect long‐term outcomes remains unclear. Multiple randomized clinical trials are underway assessing the impact of RAS and/or SGLT2 inhibition on left ventricular remodelling and outcomes following TAVR 78–80 …”