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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2014 by Oslo University Hospital.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Amjad Iqbal Hussain, Oslo University Hospital Identifier:
First received: February 16, 2013
Last updated: April 2, 2014
Last verified: April 2014
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.

Aortic Stenosis
Valvular Heart Disease
Symptomatic Aortic Stenosis

Study Type: Observational [Patient Registry]
Study Design: 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.

Resource links provided by NLM:

Further study details as provided by Oslo University Hospital:

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

Secondary Outcome Measures:
  • 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:
  • 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

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

Biospecimen Retention:   Samples With DNA
Serum, myocardial biopsi

Estimated Enrollment: 500
Study Start Date: February 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Elderly with severe aortic stenosis
Patients with severe symptomatic aortic stenosis referred for consideration of surgical aortic valve replacement

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.


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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

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
Study First Received: February 16, 2013
Last Updated: April 2, 2014

Keywords provided by 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 processed this record on April 26, 2017