Low Flow Low Gradient Aortic Stenosis Relevance of the (re)Search for a Contractile Reserve

Completed

• Conditions: Aortic Valve Stenosis
• Interventions: Device: Electrocardiogram; Device: 2D and 3D echocardiography; Device: Dobutamine stress echocardiography; Biological: Blood tests; Device: Cardiac MRI; Device: Cardiac scanner; Other: 6-minutes walking test; Other: Duke Activity Score

• Registration Number: NCT02727504
• Lead Sponsor: Rennes University Hospital

Brief Summary

Investigators sought to demonstrate that the increase in the stroke volume during a dobutamine stress echocardiography might impact the prognosis of a patient addressed for a low flow low gradient suspected severe aortic valve stenosis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-21
• Study First Submitted QC: 2016-03-29
• Study First Posted: 2016-04-04
• Study Start: 2016-05-11
• Primary Completion: 2020-01-06
• Study Completion: 2020-01-06
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-06
• Last Update Posted: 2020-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

• Patient from 45 to 90 years old
• Patient agreeing freely to participate in the study
• Aortic surface area suspected to be < 1 cm² or < 0.6 cms²/m²
• Low aortic gradient defined by a mean pressure gradient < 40 mmHg
• Aortic low flow defined by: a stroke volume indexed < 35 ml/m2
• Any contra-indication for the realization of the MRI

Exclusion Criteria

• Heart rhythm disorders
• Presence of comorbidity altering the 2-year prognosis of a patient (cancer, terminal renal insufficiency (GFR 30 ml / min / 1,73m2), liver cirrhosis, respiratory insufficiency (VEMS 1 L)
• Presence of a concomitant valvular heart disease with stenosis or regurgitation > moderated
• Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient with aortic valve stenosis	Electrocardiogram	115 patients will undergo a medical examination in order to analyse their medical history, cardiovascular parameters and check inclusion and non-inclusion criterions. Then will be performed : * An electrocardiogram * 2D and 3D echocardiography * Dobutamine stress echocardiography * Blood tests : blood electrolytes, creatinine, hemoglobin, N-terminal pro-brain natriuretic peptide (NT-ProBNP), C reactive protein (CRP), soluble suppression of tumorigenicity-2 (ST-2) * A cardiac MRI * A cardiac scanner * A 6-minutes walking test * An evolution of the Duke Activity Score
Patient with aortic valve stenosis	2D and 3D echocardiography	115 patients will undergo a medical examination in order to analyse their medical history, cardiovascular parameters and check inclusion and non-inclusion criterions. Then will be performed : * An electrocardiogram * 2D and 3D echocardiography * Dobutamine stress echocardiography * Blood tests : blood electrolytes, creatinine, hemoglobin, N-terminal pro-brain natriuretic peptide (NT-ProBNP), C reactive protein (CRP), soluble suppression of tumorigenicity-2 (ST-2) * A cardiac MRI * A cardiac scanner * A 6-minutes walking test * An evolution of the Duke Activity Score
Patient with aortic valve stenosis	Blood tests	115 patients will undergo a medical examination in order to analyse their medical history, cardiovascular parameters and check inclusion and non-inclusion criterions. Then will be performed : * An electrocardiogram * 2D and 3D echocardiography * Dobutamine stress echocardiography * Blood tests : blood electrolytes, creatinine, hemoglobin, N-terminal pro-brain natriuretic peptide (NT-ProBNP), C reactive protein (CRP), soluble suppression of tumorigenicity-2 (ST-2) * A cardiac MRI * A cardiac scanner * A 6-minutes walking test * An evolution of the Duke Activity Score
Patient with aortic valve stenosis	Cardiac MRI	115 patients will undergo a medical examination in order to analyse their medical history, cardiovascular parameters and check inclusion and non-inclusion criterions. Then will be performed : * An electrocardiogram * 2D and 3D echocardiography * Dobutamine stress echocardiography * Blood tests : blood electrolytes, creatinine, hemoglobin, N-terminal pro-brain natriuretic peptide (NT-ProBNP), C reactive protein (CRP), soluble suppression of tumorigenicity-2 (ST-2) * A cardiac MRI * A cardiac scanner * A 6-minutes walking test * An evolution of the Duke Activity Score
Patient with aortic valve stenosis	Dobutamine stress echocardiography	115 patients will undergo a medical examination in order to analyse their medical history, cardiovascular parameters and check inclusion and non-inclusion criterions. Then will be performed : * An electrocardiogram * 2D and 3D echocardiography * Dobutamine stress echocardiography * Blood tests : blood electrolytes, creatinine, hemoglobin, N-terminal pro-brain natriuretic peptide (NT-ProBNP), C reactive protein (CRP), soluble suppression of tumorigenicity-2 (ST-2) * A cardiac MRI * A cardiac scanner * A 6-minutes walking test * An evolution of the Duke Activity Score
Patient with aortic valve stenosis	6-minutes walking test	115 patients will undergo a medical examination in order to analyse their medical history, cardiovascular parameters and check inclusion and non-inclusion criterions. Then will be performed : * An electrocardiogram * 2D and 3D echocardiography * Dobutamine stress echocardiography * Blood tests : blood electrolytes, creatinine, hemoglobin, N-terminal pro-brain natriuretic peptide (NT-ProBNP), C reactive protein (CRP), soluble suppression of tumorigenicity-2 (ST-2) * A cardiac MRI * A cardiac scanner * A 6-minutes walking test * An evolution of the Duke Activity Score
Patient with aortic valve stenosis	Cardiac scanner	115 patients will undergo a medical examination in order to analyse their medical history, cardiovascular parameters and check inclusion and non-inclusion criterions. Then will be performed : * An electrocardiogram * 2D and 3D echocardiography * Dobutamine stress echocardiography * Blood tests : blood electrolytes, creatinine, hemoglobin, N-terminal pro-brain natriuretic peptide (NT-ProBNP), C reactive protein (CRP), soluble suppression of tumorigenicity-2 (ST-2) * A cardiac MRI * A cardiac scanner * A 6-minutes walking test * An evolution of the Duke Activity Score
Patient with aortic valve stenosis	Duke Activity Score	115 patients will undergo a medical examination in order to analyse their medical history, cardiovascular parameters and check inclusion and non-inclusion criterions. Then will be performed : * An electrocardiogram * 2D and 3D echocardiography * Dobutamine stress echocardiography * Blood tests : blood electrolytes, creatinine, hemoglobin, N-terminal pro-brain natriuretic peptide (NT-ProBNP), C reactive protein (CRP), soluble suppression of tumorigenicity-2 (ST-2) * A cardiac MRI * A cardiac scanner * A 6-minutes walking test * An evolution of the Duke Activity Score

Primary Outcome Measures

Name	Time	Method
Number of death of all cause	Month 12
Number of emergent hospitalization for any cardiovascular reason	Month 12

Secondary Outcome Measures

Name	Time	Method
Death (all causes)	12 months
Emergency Cardiovascular hospitalization	12 months
Change in left ventricular ejection fraction (LVEF), in global longitudinal strain in 2D and or 3D echocardiography	Inclusion, 12 months
Symptoms evolution	Inclusion, 12 months	Duke Activity Score

Trial Locations

Locations (1)

CHU de Rennes; 🇫🇷 Rennes, France