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Trial record 8 of 228 for:    Recruiting, Not yet recruiting, Available Studies | Aortic stenosis

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

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ClinicalTrials.gov Identifier: NCT02727504
Recruitment Status : Recruiting
First Posted : April 4, 2016
Last Update Posted : January 28, 2019
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

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.

Condition or disease Intervention/treatment
Aortic Valve Stenosis 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

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Study Type : Observational
Estimated Enrollment : 115 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Low Flow Low Gradient Aortic Stenosis Relevance of the (re)Search for a Contractile Reserve
Study Start Date : May 11, 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Dobutamine

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with low flow low gradient aortic stenosis
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02727504


Contacts
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Contact: Erwan Donal, MD, PhD 02 99 28 94 75 erwan.donal@chu-rennes.fr

Locations
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France
CHU de Rennes Recruiting
Rennes, France, 35033
Contact: Erwan Donal, MD, PhD         
Sponsors and Collaborators
Rennes University Hospital

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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT02727504     History of Changes
Other Study ID Numbers: 2015-A00896-43
35RC15_9884_LOWAS ( Other Identifier: CHU de Rennes )
First Posted: April 4, 2016    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Rennes University Hospital:
Aortic valve stenosis
low flow
dobutamine stress echocardiography

Additional relevant MeSH terms:
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Constriction, Pathologic
Aortic Valve Stenosis
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Dobutamine
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents