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

NCT02727504 | Completed DMC

• 2 other identifiers: 2015-A00896-4335RC15_9884_LOWAS
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Valve Stenosis

Keywords

Aortic valve stenosis; low flow; dobutamine stress echocardiography

Outcome Measures

Primary Outcomes (2)

• Number of death of all cause

  Month 12

• Number of emergent hospitalization for any cardiovascular reason

  Month 12

Secondary Outcomes (5)

• 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

• Symptoms evolution

  Inclusion, 12 months

Study Arms (1)

Patient with aortic valve stenosis

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

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

Interventions

Electrocardiogram DEVICE

ECG at inclusion and M12

Patient with aortic valve stenosis

2D and 3D echocardiography DEVICE

2D and 3D echocardiography at inclusion and M12

Patient with aortic valve stenosis

Dobutamine stress echocardiography DEVICE

dobutamine stress echocardiography at inclusion

Patient with aortic valve stenosis

Blood tests BIOLOGICAL

Blood test electrolytes, creatinine, hemoglobin, NT-proBNP, CRP, ST-2 at inclusion and M12

Patient with aortic valve stenosis

Cardiac MRI DEVICE

Cardiac MRI at inclusion

Patient with aortic valve stenosis

Cardiac scanner DEVICE

Cardiac scanner at inclusion

Patient with aortic valve stenosis

6-minutes walking test OTHER

6-minutes walking test at inclusion and M12

Patient with aortic valve stenosis

Duke Activity Score OTHER

Duke Activity Score at inclusion and M12

Patient with aortic valve stenosis

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with low flow low gradient aortic stenosis

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

CHU de Rennes

Rennes, 35033, France

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Electrocardiography; Echocardiography, Three-Dimensional; Echocardiography, Stress; Hematologic Tests

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Echocardiography; Cardiac Imaging Techniques; Diagnostic Imaging; Imaging, Three-Dimensional; Ultrasonography; Clinical Laboratory Techniques; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2016
• First Posted: April 4, 2016
• Study Start: May 11, 2016
• Primary Completion: January 6, 2020
• Study Completion: January 6, 2020
• Last Updated: February 7, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)