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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Oslo University Hospital
Sponsor:
Information provided by (Responsible Party):
Amjad Iqbal Hussain, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01794832
First received: February 16, 2013
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • MACE ( Major cardiovascular events ) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

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)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

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 ClinicalTrials.gov identifier: NCT01794832

Contacts
Contact: Amjad I Hussain, Md 0047 98043412 amhu@ous-hf.no

Locations
Norway
Oslo University hospital- Rikshospitalet Recruiting
Oslo, Norway
Contact: Lars Gullestad, professor       lars.gullestad@medisin.uio.no   
Principal Investigator: Amjad Iqbal Hussain         
Principal Investigator: Andreas Auensen, Md         
Sponsors and Collaborators
Oslo University Hospital
Investigators
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

No publications provided

Responsible Party: Amjad Iqbal Hussain, Md, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01794832     History of Changes
Other Study ID Numbers: SAS
Study First Received: February 16, 2013
Last Updated: April 2, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Oslo University Hospital:
HRQoL
Aortic stenosis
Aortic valve surgery

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

ClinicalTrials.gov processed this record on November 27, 2014