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Trial record 1 of 7 for:    aortic stenosis amyloidosis
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ATTR Amyloidosis in Elderly Patients With Aortic Stenosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04061213
Recruitment Status : Recruiting
First Posted : August 19, 2019
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief Summary:

Severe aortic stenosis is defined with a mean transvalvular pressure gradient (MTPG) > 40mmHg and a calculated aortic valve area of < 1cm2. However, a considerable proportion of patients do have a MTPG < 40mmHg due to a reduced stroke volume (stroke volume indexed to body surface area ≤ 35ml/m2) despite a normal left ventricular ejection fraction (LVEF > 50%). This entity is termed paradoxical low flow low gradient aortic stenosis (PLFLG AS) and is associated with a worse prognosis.

ATTR amyloidosis is a disease of the elderly and might coexist in patients with severe aortic stenosis. Case reports and small observational studies suggest that senile ATTR amyloidosis could be frequent but underdiagnosed in patients with aortic stenosis. There is significant overlap between PLFLG AS and cardiac amyloidosis with regard to symptoms, increasing prevalence with age, concentric hypertrophy, impaired diastolic filling of the left ventricle (LV), as well as longitudinal LV dysfunction despite preserved ejection fraction - all features, which lead to a reduction in stroke volume, the underlying mechanism of the low flow condition as observed in PLFLG AS patients.


Condition or disease Intervention/treatment
Aortic Stenosis Symptomatic Amyloidosis Cardiac Diagnostic Test: Tc-99m-DPD scintigraphy

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: ATTR Amyloidosis in Elderly Patients With Aortic Stenosis
Actual Study Start Date : August 26, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022


Group/Cohort Intervention/treatment
Patients with symptomatic severe aortic stenosis
Elderly patients referred for TAVR evaluation
Diagnostic Test: Tc-99m-DPD scintigraphy
Myocardial scintigraphy




Primary Outcome Measures :
  1. Proportion of patients with grade 2 or 3 cardiac uptake in scintigraphy and without pathological light chains in immunological assays [ Time Frame: In-Hospital [7 days] ]
    Evaluation of incidence rate


Secondary Outcome Measures :
  1. All-cause and cardiovascular mortality [ Time Frame: 30 days, 12months ]
    Clinical Endpoints

  2. CPET - maximal exercise capacity [ Time Frame: In-Hospital [7 days] ]
    Functional Endpoints



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with symptomatic, severe aortic stenosis undergoing pre-evaluation for (transcatheter) aortic valve replacement
Criteria

Inclusion Criteria:

  • Symptomatic, severe aortic stenosis

Exclusion Criteria:

  • More than mild valvular disease of any other valve
  • Other severe disease with a life expectancy < 1 year
  • Participating in trial interfering with routine clinical practice or use of a non-CE marked device

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): NCT04061213


Contacts
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Contact: Stefan Stortecky, MD 0041 31 632 83 52 stefan.stortecky@insel.ch

Locations
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Switzerland
University Hospital Bern - Inselspital Recruiting
Bern, BE, Switzerland, 3010
Contact: Stefan Stortecky, MD    0041 31632 83 52    stefan.stortecky@insel.ch   
Contact: Stephan Dobner, MD    0041 31 632 21 11    stephan.dobner@insel.ch   
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Stefan Stortecky, MD Swiss Cardiovascular Center Bern
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT04061213    
Other Study ID Numbers: 4083 / KEK-Nr. 2019-00880
First Posted: August 19, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Amyloidosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Proteostasis Deficiencies
Metabolic Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Technetium Tc 99m 1,1-diphosphonopropane-2,3-dicarboxylic acid
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action