Clinical Value of Stress Echocardiography in Moderate Aortic Stenosis

NCT02792452 | Completed

• 1 other identifier: AV AS-01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The management of symptomatic patients with moderate Aortic Stenosis (AS) remains challenging and tests that would give more definitive answers are needed. The value of increase in Aortic Valve mean Gradient (AVMG), lack of change in Aortic Valve area (AVA) and calculation of valve compliance/resistance during stress echo (SE) in the symptomatic moderate AS population prognostication has to the investigators knowledge not been examined before. Similarly the additive value of myocardial blood flow reserve (MBFR), Computed Tomography (CT) calcium score, speckle tracking echocardiography, carotid ultrasonography, and N-Terminal pro B- type natriuretic peptide B (NT-proBNP) in the prognostication of this population group especially in combination with SE remains unclear.

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (3)

• Death (cardiovascular/all cause)

  between baseline and two years

• Hospitalisation for heart failure

  between baseline and two years

• Aortic valve replacement (TAVI or surgical AVR)

  between baseline and two years

Secondary Outcomes (2)

• Change in AS severity (progression to severe) as measured by quantitive echocardiography

  Between baseline and one year

• change in LV systolic function as measured by quantitive echocardiography

  Between baseline and one year

Eligibility Criteria

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

Study Population

Suitable patients with moderate Aortic stenosis will be identified from the Echocardiography labs of the two trusts (London North West Healthcare NHS Trust and Royal Brompton Hospital) and will be approached for enrolment in the study.

You may qualify if:

• Age ≥18 years
• Moderate AS with AVA between 1-1.4cm2, and AVMG\<40 millimetres of Mercury (mmHg); and
• Left Ventricular Ejection Fraction (LVEF) ≥50%; and
• Cardiac related symptoms; shortness of breath, chest pain or syncope.

You may not qualify if:

• Inability to exercise and undertake pharmacological stress, ie previously known intolerance to dobutamine;
• Severe aortic or mitral regurgitation or severe mitral stenosis;
• Significant pulmonary disease like severe (Chronic Obstructive Pulmonary Disease (COPD) or pulmonary fibrosis;
• Atrial fibrillation;
• Inability to provide informed consent;
• Pregnancy;
• Other known non-cardiovascular disease associated with poor prognosis like metastatic cancer.

Sponsors & Collaborators

• London North West Healthcare NHS Trust: lead

Study Sites (1)

Northwick Park Hospital

Harrow, MIddx, HA1 3UJ, United Kingdom

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Roxy Senior, MD,DM,FRCP

  London North West Healthcare NHS Trust

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: May 19, 2016
• First Posted: June 7, 2016
• Study Start: September 1, 2016
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: February 12, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)