NCT04514250: SAVI-AoS

Stress Aortic Valve Index for Assessing Risk in Aortic Valve Stenosis Patients

Active, enrolled Last updated 14 February 2024

What this trial tests

trial in Aortic Valve Stenosis in 52 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

14 April 2021

Primary endpoint
1 October 2024

1 October 2028

Quick facts

Lead sponsor	Catharina Ziekenhuis Eindhoven
Status	Active, enrolled
Study type	OBSERVATIONAL
Enrollment	52
Start date	14 April 2021
Primary completion	1 October 2024
Estimated completion	1 October 2028
Sites	5 locations across Denmark, Netherlands, United States

Conditions studied

• Aortic Valve Stenosis — all drugs for Aortic Valve Stenosis →

Sponsor

Catharina Ziekenhuis Eindhoven — full company profile →

Who can join

50 and older, any sex, with Aortic Valve Stenosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Discrepancies exist among aortic stenosis severity classification, patient symptom burden, and - in some cases - even survival. The new Stress Aortic Valve Index (SAVI) metric correlates better with transvalvular flow and might be a better predictor of symptoms and prognosis.

The current study will demonstrate the value of SAVI (both non-invasive and invasive) in patients with moderate aortic stenosis.

The population will consist of subjects at least 50 years old with moderate aortic stenosis (defined as aortic valve area \>1.0 cm2 plus either maximal velocity 2.5-3.9 m/s or mean gradient 15-39 mmHg). Subjects with severe concomitant valve disease or severe unrevascularized coronary artery disease will be excluded, so that the isolated prognosis of aortic stenosis can be investigated.

All subjects will undergo invasive SAVI measurements during catheterization. Furthermore patients will receive non-invasive testing with an exercise echocardiogram and computed tomography (CT) scan for non-invasive SAVI measurements.

The short-term objective will compare SAVI with standard resting indexes for symptom burden, functional capacity, and biomarkers. The long-term objective will associate SAVI and standard resting indexes with clinical outcomes related to valvular disease. The investigators hypothesize that low SAVI (more marked AS during stress) will track with more symptoms and a worse prognosis.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The patients will have several study visits. The index visit will be planned to obtain informed consent and baseline parameters. The measurement visit(s) will consist of the invasive SAVI measurement, echocardiogram, stress echo imaging, 6-minute walk test, quality of life questionnaire, and the cardiac CT. During the final visit after 12 months, subjects will undergo a CT valvular calcium scan, quality of life questionnaire, and 6-minute walk test. Every subject will have an echocardiogram yearly as suggested by guideline criteria and could possibly be contacted until five years after enrollment. Blood samples will be drawn at baseline and the 1-year follow-up. Potentially the new SAVI metric could identify patients at higher risk among those with moderate gradient AS. However, since no outcome data currently exists regarding SAVI and prognosis, no conclusions could be derived from these measurements until study completion.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Severe Aortic Stenosis With Coronary Disease: Do Not Get Distracted!
   Johnson NP, Eerdekens R, Tonino PAL. · · 2022 · cited 1× · PMID 36444177 · DOI 10.1016/j.jaccas.2022.08.036
2. Rationale and design of <b>SAVI-AoS:</b> A <b>physiologic</b> study of patients with symptomatic moderate aortic valve stenosis and preserved left ventricular ejection fraction.
   Eerdekens R, Tonino P, Zelis J, Adrichem R, et al · · 2022 · cited 1× · PMID 35663622 · DOI 10.1016/j.ijcha.2022.101063