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

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.

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: 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

• Study Type: Observational
• Enrollment (Actual): 86

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35033
    • CHU de Rennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with low flow low gradient aortic stenosis

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; ECG at inclusion and M12; Device: 2D and 3D echocardiography; 2D and 3D echocardiography at inclusion and M12; Device: 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; Device: Cardiac scanner; Cardiac scanner at inclusion; Other: 6-minutes walking test; 6-minutes walking test at inclusion and M12; Other: Duke Activity Score; Duke Activity Score at inclusion and M12

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of death of all cause	Month 12
Number of emergent hospitalization for any cardiovascular reason	Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6-minute walking test	Inclusion, 12 months
Symptoms evolution	Duke Activity Score	Inclusion, 12 months

Collaborators and Investigators

• Sponsor: Rennes University Hospital

Study record dates

Study Major Dates

• Study Start: May 11, 2016
• Primary Completion (Actual): January 6, 2020
• Study Completion (Actual): January 6, 2020

Study Registration Dates

• First Submitted: March 21, 2016
• First Submitted That Met QC Criteria: March 29, 2016
• First Posted (Estimate): April 4, 2016

Study Record Updates

• Last Update Posted (Actual): February 7, 2020
• Last Update Submitted That Met QC Criteria: February 6, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Aortic valve stenosis; low flow; dobutamine stress echocardiography
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Adrenergic Agonists; Cardiotonic Agents; Adrenergic beta-Agonists; Sympathomimetics; Adrenergic beta-1 Receptor Agonists; Dobutamine
• Other Study ID Numbers: 2015-A00896-43; 35RC15_9884_LOWAS (Other Identifier: CHU de Rennes)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No