Aortic Valve StenosisSAVI-AoSNCT04514250
Stress Aortic Valve Index for Assessing Risk in Aortic Valve Stenosis Patients
An observational study of Aortic Valve Stenosis, run by Catharina Ziekenhuis Eindhoven at 5 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- How many people
- 52 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 14 Apr 2021to 1 Oct 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Adult, Older adult
Study population: The study population will consist of symptomatic moderate aortic stenosis patients defined as: aortic valve area >1.0 cm2 plus either maximal velocity 2.5-3.9 m/s or mean gradient 15-39 mmHg. Earlier studies show that patients with moderate AS are about 75 years old and almost half are female. Their survival at one and five years is around 90% and 75% - almost the same as patients diagnosed with severe AS.
Who may be able to join
- 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
Who cannot join
- 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)
Show all 17Show fewer
- 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
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United States2 sites
UTHealth Houston, McGovern Medical School
Houston, Texas, 77030
UMass Medical Memorial Center
Worcester, Massachusetts, 01655
Netherlands2 sites
Catharina Hospital Eindhoven
Eindhoven, 5623EJ
Erasmus University Medical Center
Rotterdam
About this study
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.
Read more
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.
- Conditions
- Aortic Valve Stenosis
- Medical subject headings
- Aortic Valve Stenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the valve metrics vs baseline clinical parameters (KCCQ)
A primary endpoint is the comparison of baseline clinical parameters (quality of life survey (Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS) (score 1-100), between SAVI (dimensionless) and each of mean aortic gradient (mmHg), aortic valve area (cm2), and maximal aortic valve velocity (m/s)
Measured: 1 to 5 years
Evaluation of the valve metrics vs baseline clinical parameters (6MWT)
A primary endpoint is the comparison of baseline clinical parameters (6 minute walking test (6MWT) (meters), between SAVI (dimensionless) and each of mean aortic gradient (mmHg), aortic valve area (cm2), and maximal aortic valve velocity (m/s)
Measured: 1 to 5 years
Evaluation of the valve metrics vs baseline clinical parameters (biomarkers)
A primary endpoint is the comparison of baseline clinical parameters (biomarkers (NT-proBNP (pg/ml); troponin (ng/L))), between SAVI (dimensionless) and each of mean aortic gradient (mmHg), aortic valve area (cm2), and maximal aortic valve velocity (m/s)
Measured: 1 to 5 years
Secondary outcomes (2)
Correlation between invasive (cardiac catherization) and non-invasive (stress echocardiography; computational fluid dynamics obtained from CT scan data) SAVI measurements
Secondary endpoints will include correlations between invasive (with pressures (mmHg) obtained during cardiac catheterization) and noninvasive (calculated based on pressures (mmHg) achieved during echocardiographic/computional fluid dynamics) SAVI (dimensionless) measurements to explore if stress assessment of the aortic valve can be imaged non-invasively or if it requires invasive hemodynamic measurement for acceptable precision. The same will be done with the cardiac CT scans that will be analyzed to see if computational fluid dynamics can simulate invasive SAVI (dimensionless).
Measured: 1 year
SAVI vs. clinical outcome (number of hospitalizations (hear failure/angina/syncope/rhythm disturbances/valvular intervention/any death/cardiac death)
Compare SAVI (dimensionless) against standard indexes of aortic stenosis for a composite clinical endpoint of hospital admission for heart failure, angina or syncope, arrhythmia (atrial fibrillation, ventricular tachycardia), valvular intervention (SAVR, TAVI, balloon valvuloplasty), death of any cause, and cardiac death
Measured: 1 to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start14 Apr 2021
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr Pim A.L. Tonino, Catharina Ziekenhuis Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04514250
- Sponsor's protocol ID
- SAVI-AoS NL74875.100.20
- Acronym
- SAVI-AoS
- Status last verified
- Feb 2024
- First submitted
- 12 Aug 2020
- Last updated
- 14 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Aortic Valve Index for Assessing Risk in Aortic Valve Stenosis Patients
- ClinicalTrials.gov ID
- NCT04514250
- Acronym / sponsor ID
- SAVI-AoS / SAVI-AoS NL74875.100.20
- Conditions
- Aortic Valve Stenosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 14 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of symptomatic moderate aortic stenosis patients defined as: aortic valve area >1.0 cm2 plus either maximal velocity 2.5-3.9 m/s or mean gradient 15-39 mmHg. Earlier studies show that patients with moderate AS are about 75 years old and almost half are female. Their survival at one and five years is around 90% and 75% - almost the same as patients diagnosed with severe AS.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (17 listed)
- 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%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of the valve metrics vs baseline clinical parameters (KCCQ)
Time frame: 1 to 5 years
A primary endpoint is the comparison of baseline clinical parameters (quality of life survey (Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS) (score 1-100), between SAVI (dimensionless) and each of mean aortic gradient (mmHg), aortic valve area (cm2), and maximal aortic valve velocity (m/s)
Evaluation of the valve metrics vs baseline clinical parameters (6MWT)
Time frame: 1 to 5 years
A primary endpoint is the comparison of baseline clinical parameters (6 minute walking test (6MWT) (meters), between SAVI (dimensionless) and each of mean aortic gradient (mmHg), aortic valve area (cm2), and maximal aortic valve velocity (m/s)
Evaluation of the valve metrics vs baseline clinical parameters (biomarkers)
Time frame: 1 to 5 years
A primary endpoint is the comparison of baseline clinical parameters (biomarkers (NT-proBNP (pg/ml); troponin (ng/L))), between SAVI (dimensionless) and each of mean aortic gradient (mmHg), aortic valve area (cm2), and maximal aortic valve velocity (m/s)
2 secondary outcomes
Correlation between invasive (cardiac catherization) and non-invasive (stress echocardiography; computational fluid dynamics obtained from CT scan data) SAVI measurements
Time frame: 1 year
SAVI vs. clinical outcome (number of hospitalizations (hear failure/angina/syncope/rhythm disturbances/valvular intervention/any death/cardiac death)
Time frame: 1 to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis, run by Catharina Ziekenhuis Eindhoven at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Netherlands, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the valve metrics vs baseline clinical parameters (KCCQ) (time frame: 1 to 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.