Severe Aortic Stenosis in Patients Referred for Valve Surgery (SAS)

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. Read our disclaimer for details. Identifier: NCT01794832
Recruitment Status : Unknown
Verified April 2014 by Amjad Iqbal Hussain, Oslo University Hospital.
Recruitment status was:  Recruiting
First Posted : February 20, 2013
Last Update Posted : April 3, 2014
Information provided by (Responsible Party):
Amjad Iqbal Hussain, Oslo University Hospital

Brief Summary:
Our main hypothesis on the present study is that new parameters such as risk-taking behavior, patients motivation, health related quality of life, new biomarkers and more precise echocardiography measures in addition to traditional parameters will improve pre-operative risk assessment in patients with AS and better guide patients and doctors in decision whether to operate or not.

Condition or disease
Aortic Stenosis Valvular Heart Disease Symptomatic Aortic Stenosis

Detailed Description:

Patients referred for surgery are included thorough reading referral letter. Data collected in the study wil be compared with data from Medical records and clinical examination.

Data entered will be controlled by two investigators.

Data wil be compared to national norms and from result of other studies.

Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: A Prospective Longitudinal Study of Severe Aortic Stenosis in Elderly and Outcome of Aortic Surgery.
Study Start Date : February 2010
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Elderly with severe aortic stenosis
Patients with severe symptomatic aortic stenosis referred for consideration of surgical aortic valve replacement

Primary Outcome Measures :
  1. Death due cardiovascular events [ Time Frame: one year ]

Secondary Outcome Measures :
  1. MACE ( Major cardiovascular events ) [ Time Frame: 30 days ]
    Cerebral complications (stroke/bleeding), bleeding, renal failure, arrythmias, needs for pacemaker, prolong ICU stay, wound infections

Other Outcome Measures:
  1. Change in Health related Quality and function one year after inclusion [ Time Frame: one year ]
    Patients in the study perform Short Form-36, EuroQual-5D at inclusion and one year after. We want to compare the result of their scoring to obtain the gain in HRQoL of the intervention

  2. Hospital visit and use of Health services last years [ Time Frame: 30 days ]

Biospecimen Retention:   Samples With DNA
Serum, myocardial biopsi

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Inclusion: Patients above 18 years with symptomatic AS referred to preoperative examination will be included. Patients will undergo standard investigations with regard to assessment of the clinical indication for operation

Inclusion Criteria:

  • Patients above 18 years with symptomatic AS referred to preoperative examination.

Exclusion Criteria:

  • Exclusion: Patients who do not want to participate. Patients not able to speak and read Norwegian.

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 identifier (NCT number): NCT01794832

Contact: Amjad I Hussain, Md 0047 98043412

Oslo University hospital- Rikshospitalet Recruiting
Oslo, Norway
Contact: Lars Gullestad, professor   
Principal Investigator: Amjad Iqbal Hussain         
Principal Investigator: Andreas Auensen, Md         
Sponsors and Collaborators
Oslo University Hospital
Study Director: Kjell I Pettersen, MD University of Oslo
Principal Investigator: Amjad I Hussain, MD Oslo University Hosptial
Study Chair: Lars Gullestad, Professor Oslo University Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Amjad Iqbal Hussain, Md, Oslo University Hospital Identifier: NCT01794832     History of Changes
Other Study ID Numbers: SAS
First Posted: February 20, 2013    Key Record Dates
Last Update Posted: April 3, 2014
Last Verified: April 2014

Keywords provided by Amjad Iqbal Hussain, Oslo University Hospital:
Aortic stenosis
Aortic valve surgery

Additional relevant MeSH terms:
Heart Diseases
Constriction, Pathologic
Aortic Valve Stenosis
Heart Valve Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Ventricular Outflow Obstruction