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OpenTrials
Completed

NCT Number: NCT02727504

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

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.

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Key information

Conditions

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

Age range

45 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Rennes

Rennes, 35033, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electrocardiogram

Device

ECG at inclusion and M12

2D and 3D echocardiography

Device

2D and 3D echocardiography at inclusion and M12

Dobutamine stress echocardiography

Device

dobutamine stress echocardiography at inclusion

Blood tests

Biological

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

Cardiac MRI

Device

Cardiac MRI at inclusion

Cardiac scanner

Device

Cardiac scanner at inclusion

6-minutes walking test

Other

6-minutes walking test at inclusion and M12

Duke Activity Score

Other

Duke Activity Score at inclusion and M12

Primary outcomes

  1. Number of death of all cause

    Time frame: Month 12

  2. Number of emergent hospitalization for any cardiovascular reason

    Time frame: Month 12

Secondary outcomes

  1. Death (all causes)

    Time frame: 12 months

  2. Emergency Cardiovascular hospitalization

    Time frame: 12 months

  3. Change in left ventricular ejection fraction (LVEF), in global longitudinal strain in 2D and or 3D echocardiography

    Time frame: Inclusion, 12 months

  4. Symptoms evolution

    Time frame: Inclusion, 12 months

    6-minute walking test

  5. Symptoms evolution

    Time frame: Inclusion, 12 months

    Duke Activity Score

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: LOWAS

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Apr 4, 2016
Registry last updated
Feb 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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