ANZCTR - Registration

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04514250

Registration number

NCT04514250

Ethics application status

Date submitted

12/08/2020

Date registered

14/08/2020

Date last updated

14/02/2024

Titles & IDs

Public title

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

Scientific title

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

Secondary ID [1]

SAVI-AoS NL74875.100.20

Universal Trial Number (UTN)

Trial acronym

SAVI-AoS

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Aortic Valve Stenosis

Condition category

Condition code

Intervention/exposure

Study type

Observational [Patient Registry]

Patient registry

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Evaluation of the valve metrics vs baseline clinical parameters (KCCQ)

Timepoint [1]

1 to 5 years

Primary outcome [2]

Evaluation of the valve metrics vs baseline clinical parameters (6MWT)

Timepoint [2]

1 to 5 years

Eligibility

Key inclusion criteria

* Age = 50 years
* Moderate aortic stenosis confirmed in the past 3 months by standard echocardiographic evaluation: aortic valve area >1.0 cm2 plus either maximal velocity 2.5-3.9 m/s or mean gradient 15-39 mmHg
* Ability to undergo exercise stress testing
* Ability to understand and the willingness to provide written informed consent

Minimum age

50 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study

* Any hemodynamic criterion for severe AS: maximal velocity >= 4 m/s, mean gradient >= 40mmHg, aortic valve area =< 1 cm2
* Percutaneous coronary intervention or coronary artery bypass grafting in the past three months, or have revascularization planned in the near future
* Known, unrevascularized, and severe coronary artery disease (for example a 90% diameter stenosis or FFR<0.7 in the proximal left anterior descending artery)
* Impaired left ventricular function (ejection fraction <50%)
* Unicuspid, bicuspid, or non-calcified aortic valve observed during echocardiography (note that later cusp fusion noted during study-related cardiac imaging will not exclude a subject)
* Severe aortic regurgitation, mitral valve disease, tricuspid regurgitation, or a significant intracardiac shunt
* Co-existing hypertrophic cardiomyopathy or severe septal hypertrophy >15mm
* Persistent atrial fibrillation with uncontrolled ventricular response
* Recent (within 6 weeks) acute coronary syndrome
* Estimated glomerular filtration rate =30 mL/min or end-stage renal disease on replacement therapy (dialysis)
* Severe COPD GOLD stage 3 or 4, home oxygen dependence, or =2 pulmonary inhalers (note that well-treated and stable asthma and GOLD stage 1 or 2 COPD is permitted)
* Severe comorbid condition with life expectancy <2 years
* Prior adverse reaction to dobutamine
* Severe iodine contrast allergy
* Pregnancy
* Severe pulmonary hypertension with systolic pulmonary artery pressure greater than 50mmHg or isolated and symptomatic right ventricular failure

Study design

Purpose

Duration

Selection

Timing

Prospective

Statistical methods / analysis

Recruitment

Recruitment status

Active, not recruiting

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

14/04/2021

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

1/10/2028

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Primary sponsor type

Other

Name

Catharina Ziekenhuis Eindhoven

Address

Country

Ethics approval

Ethics application status

Summary

Brief summary

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.

Trial website

https://clinicaltrials.gov/study/NCT04514250

Trial related presentations / publications

Public notes

 This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04514250

Trial Review

Registering a new trial?

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04514250