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Early Surgery for Patients With Asymptomatic Aortic Stenosis (ESTIMATE)

Primary Purpose

Aortic Valve Stenosis, Aortic Valve Surgery

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Early surgical aortic valve replacement
Delayed Surgical aortic valve replacement
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Aortic Valve Stenosis focused on measuring Aortic valve, Stenosis, Surgery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

  • Adult patient, aged between 18 and 80 years (18 ≤ age ≤80)
  • Low operative risk, defined as EuroSCORE II ≤ 5%
  • No symptom potentially attributable to AS: no dyspnea, angina or syncope during exercise
  • No class I indication for surgery
  • No symptom/ fall in blood pressure during exercise test
  • Severe AS according to current echocardiography criteria: Vmax > 4.0 m/s and/ or MPG > 40 mm Hg); AVA < 1.0 cm2 (not mandatory)
  • Preserved LV systolic function: LVEF >50% according to echocardiography ; no LV wall motion abnormality
  • Signed informed consent

Exclusion criteria

  • Moderate/ high operative risk for aortic valve replacement, defined as EuroSCORE II > 5%
  • Class-I indication for AVR (ESC-EACTS 2012, ACC/ AHA 2014) or fall in blood pressure during exercise testing (Class-IIa)
  • Other indication for cardiac surgery (CABG, thoracic aorta)
  • Positive exercise test including A/ unmasking of symptoms (angina, dyspnea at low workload, dizziness or syncope) during exercise or B/ Fall in systolic blood pressure during exercise below the baseline value.
  • Patients unable to perform the exercise ECG
  • More than mild AR (>grade 2/4)/ other significant valve disease LVEF ≤ 50%
  • Serum creatinine >160 μmol/L
  • Serious extra cardiac comorbidity/ life expectancy <2 years
  • Patient included in another trial with signed informed consent
  • Patient not affiliated to social insurance
  • Pregnancy

Sites / Locations

  • Henri Mondor HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early surgery

Delayed surgery according to guidelines

Arm Description

Surgical aortic valve replacement

Surgical aortic valve replacement

Outcomes

Primary Outcome Measures

Combination of overall mortality and cardiac morbidity
Any adverse cardiac event requiring hospitalization. Adverse cardiac events include: 1/ development of any symptom clearly related to AS (dyspnea, angina, pre-syncope or syncope during exercise); 2/ major adverse cardiac events defined as congestive heart failure or acute coronary syndrome; 3/ death of any cause, including cardiac death.

Secondary Outcome Measures

Each items of the composite criteria, overall and cardiovascular mortality and cardiac morbidity
Number of patients with preserved LV systolic function ( LVEF >50% according to echocardiography ) in each group
Performance capacities assessed by speckle-tracking imaging (longitudinal function) in each group
Postoperative Exercise test (Exercise Electrocardiogram)

Full Information

First Posted
November 25, 2015
Last Updated
July 3, 2017
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02627391
Brief Title
Early Surgery for Patients With Asymptomatic Aortic Stenosis
Acronym
ESTIMATE
Official Title
Early Surgery for Patients With Asymptomatic Aortic Stenosis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (Actual)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
November 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Many cardiologists are convinced that early surgery in asymptomatic aortic stenosis (AS) saves lives. However there is currently no direct evidence for this and most recommendations from the ESC/ EACTS or ACC/ AHA in this field are supported by Level-B or C evidence. Therefore, the investigators designed a randomized controlled trial to demonstrate whether early surgery improves mortality and morbidity of patients with asymptomatic severe AS and low operative risk.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis, Aortic Valve Surgery
Keywords
Aortic valve, Stenosis, Surgery

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early surgery
Arm Type
Experimental
Arm Description
Surgical aortic valve replacement
Arm Title
Delayed surgery according to guidelines
Arm Type
Active Comparator
Arm Description
Surgical aortic valve replacement
Intervention Type
Other
Intervention Name(s)
Early surgical aortic valve replacement
Intervention Type
Other
Intervention Name(s)
Delayed Surgical aortic valve replacement
Primary Outcome Measure Information:
Title
Combination of overall mortality and cardiac morbidity
Description
Any adverse cardiac event requiring hospitalization. Adverse cardiac events include: 1/ development of any symptom clearly related to AS (dyspnea, angina, pre-syncope or syncope during exercise); 2/ major adverse cardiac events defined as congestive heart failure or acute coronary syndrome; 3/ death of any cause, including cardiac death.
Time Frame
1 year after randomization.
Secondary Outcome Measure Information:
Title
Each items of the composite criteria, overall and cardiovascular mortality and cardiac morbidity
Time Frame
1 year after randomization
Title
Number of patients with preserved LV systolic function ( LVEF >50% according to echocardiography ) in each group
Time Frame
assessed at 3 months after surgery
Title
Performance capacities assessed by speckle-tracking imaging (longitudinal function) in each group
Time Frame
assessed at 3 months after surgery
Title
Postoperative Exercise test (Exercise Electrocardiogram)
Time Frame
assessed at 3 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria Adult patient, aged between 18 and 80 years (18 ≤ age ≤80) Low operative risk, defined as EuroSCORE II ≤ 5% No symptom potentially attributable to AS: no dyspnea, angina or syncope during exercise No class I indication for surgery No symptom/ fall in blood pressure during exercise test Severe AS according to current echocardiography criteria: Vmax > 4.0 m/s and/ or MPG > 40 mm Hg); AVA < 1.0 cm2 (not mandatory) Preserved LV systolic function: LVEF >50% according to echocardiography ; no LV wall motion abnormality Signed informed consent Exclusion criteria Moderate/ high operative risk for aortic valve replacement, defined as EuroSCORE II > 5% Class-I indication for AVR (ESC-EACTS 2012, ACC/ AHA 2014) or fall in blood pressure during exercise testing (Class-IIa) Other indication for cardiac surgery (CABG, thoracic aorta) Positive exercise test including A/ unmasking of symptoms (angina, dyspnea at low workload, dizziness or syncope) during exercise or B/ Fall in systolic blood pressure during exercise below the baseline value. Patients unable to perform the exercise ECG More than mild AR (>grade 2/4)/ other significant valve disease LVEF ≤ 50% Serum creatinine >160 μmol/L Serious extra cardiac comorbidity/ life expectancy <2 years Patient included in another trial with signed informed consent Patient not affiliated to social insurance Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Luc MONIN, MD PhD.
Phone
(0)1 49 81 28 10
Ext
+33
Email
jean-luc.monin@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Luc MONIN, MD PhD.
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henri Mondor Hospital
City
Creteil
ZIP/Postal Code
94010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Luc MONIN, MD PhD
Phone
(0)1 49 81 28 10
Ext
+33
Email
jean-luc.monin@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
19546391
Citation
Monin JL, Lancellotti P, Monchi M, Lim P, Weiss E, Pierard L, Gueret P. Risk score for predicting outcome in patients with asymptomatic aortic stenosis. Circulation. 2009 Jul 7;120(1):69-75. doi: 10.1161/CIRCULATIONAHA.108.808857. Epub 2009 Jun 22.
Results Reference
background
PubMed Identifier
24774264
Citation
Farre N, Gomez M, Molina L, Cladellas M, Ble M, Roqueta C, Ascoeta MS, Comin-Colet J, Vila J, Bruguera J. Prognostic value of NT-proBNP and an adapted monin score in patients with asymptomatic aortic stenosis. Rev Esp Cardiol (Engl Ed). 2014 Jan;67(1):52-7. doi: 10.1016/j.rec.2013.06.020. Epub 2013 Oct 20.
Results Reference
background
PubMed Identifier
24603191
Citation
Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Guyton RA, O'Gara PT, Ruiz CE, Skubas NJ, Sorajja P, Sundt TM 3rd, Thomas JD; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014 Jun 10;63(22):e57-185. doi: 10.1016/j.jacc.2014.02.536. Epub 2014 Mar 3. No abstract available. Erratum In: J Am Coll Cardiol. 2014 Jun 10;63(22):2489. Dosage error in article text.
Results Reference
background
PubMed Identifier
22922415
Citation
Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC); European Association for Cardio-Thoracic Surgery (EACTS); Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Baron-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De Bonis M, Evangelista A, Falk V, Iung B, Lancellotti P, Pierard L, Price S, Schafers HJ, Schuler G, Stepinska J, Swedberg K, Takkenberg J, Von Oppell UO, Windecker S, Zamorano JL, Zembala M. Guidelines on the management of valvular heart disease (version 2012). Eur Heart J. 2012 Oct;33(19):2451-96. doi: 10.1093/eurheartj/ehs109. Epub 2012 Aug 24. No abstract available.
Results Reference
background
PubMed Identifier
10403851
Citation
Otto CM, Lind BK, Kitzman DW, Gersh BJ, Siscovick DS. Association of aortic-valve sclerosis with cardiovascular mortality and morbidity in the elderly. N Engl J Med. 1999 Jul 15;341(3):142-7. doi: 10.1056/NEJM199907153410302.
Results Reference
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Early Surgery for Patients With Asymptomatic Aortic Stenosis

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