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

Aortic Valve Stenosis Clinical Trial

— LOWAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02727504
• Other study ID #: 2015-A00896-43
• Secondary ID: 35RC15_9884_LOWA
• Status: Completed
• Start date: May 11, 2016
• Est. completion date: January 6, 2020

Study information

• Verified date: February 2020
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: January 6, 2020
• Est. primary completion date: January 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Device:
• Electrocardiogram
ECG at inclusion and M12
• 2D and 3D echocardiography
2D and 3D echocardiography at inclusion and M12
• Dobutamine stress echocardiography
dobutamine stress echocardiography at inclusion

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

Device:
• Cardiac MRI
Cardiac MRI at inclusion
• Cardiac scanner
Cardiac scanner at inclusion

Other:
• 6-minutes walking test
6-minutes walking test at inclusion and M12
• Duke Activity Score
Duke Activity Score at inclusion and M12

Locations

Country	Name	City	State
France	CHU de Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of death of all cause		Month 12
Primary	Number of emergent hospitalization for any cardiovascular reason		Month 12
Secondary	Death (all causes)		12 months
Secondary	Emergency Cardiovascular hospitalization		12 months
Secondary	Change in left ventricular ejection fraction (LVEF), in global longitudinal strain in 2D and or 3D echocardiography		Inclusion, 12 months
Secondary	Symptoms evolution	6-minute walking test	Inclusion, 12 months
Secondary	Symptoms evolution	Duke Activity Score	Inclusion, 12 months