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

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ClinicalTrials.gov 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

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Amjad Iqbal Hussain, Oslo University Hospital

Study Description

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 Design

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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

MedlinePlus Genetics related topics: Supravalvular aortic stenosis

Genetic and Rare Diseases Information Center resources: Aortic Valve Stenosis

U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
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

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

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): NCT01794832

Contacts

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

Locations

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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

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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

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Arain F, Abraityte A, Bogdanova M, Solberg OG, Michelsen AE, Lekva T, Aakhus S, Holm S, Halvorsen B, Finsen AV, Vinge LE, Nymo S, Espeland T, Ranheim T, Aukrust P, Vaage IJ, Auensen A, Gullestad L, Ueland T. YKL-40 (Chitinase-3-Like Protein 1) Serum Levels in Aortic Stenosis. Circ Heart Fail. 2020 Oct;13(10):e006643. doi: 10.1161/CIRCHEARTFAILURE.119.006643. Epub 2020 Sep 23.

Kvaslerud AB, Hussain AI, Auensen A, Ueland T, Michelsen AE, Pettersen KI, Aukrust P, Morkrid L, Gullestad L, Broch K. Prevalence and prognostic implication of iron deficiency and anaemia in patients with severe aortic stenosis. Open Heart. 2018 Dec 16;5(2):e000901. doi: 10.1136/openhrt-2018-000901. eCollection 2018.

Hussain AI, Auensen A, Brunborg C, Beitnes JO, Gullestad L, Pettersen KI. Age-dependent morbidity and mortality outcomes after surgical aortic valve replacement. Interact Cardiovasc Thorac Surg. 2018 Nov 1;27(5):650-656. doi: 10.1093/icvts/ivy154.

Auensen A, Hussain AI, Garratt AM, Gullestad LL, Pettersen KI. Patient-reported outcomes after referral for possible valve replacement in patients with severe aortic stenosis. Eur J Cardiothorac Surg. 2018 Jan 1;53(1):129-135. doi: 10.1093/ejcts/ezx228.

Hussain AI, Garratt AM, Brunborg C, Aakhus S, Gullestad L, Pettersen KI. Eliciting Patient Risk Willingness in Clinical Consultations as a Means of Improving Decision-Making of Aortic Valve Replacement. J Am Heart Assoc. 2016 Mar 18;5(3):e002828. doi: 10.1161/JAHA.115.002828.

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Responsible Party:	Amjad Iqbal Hussain, Md, Oslo University Hospital
ClinicalTrials.gov Identifier:	NCT01794832
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:


HRQoL Aortic stenosis Aortic valve surgery

Additional relevant MeSH terms:

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Heart Diseases Aortic Valve Stenosis Heart Valve Diseases Constriction, Pathologic	Cardiovascular Diseases Pathological Conditions, Anatomical Aortic Valve Disease Ventricular Outflow Obstruction

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