Clinical trial NCT01794832: Severe Aortic Stenosis in Patients Referred for Valve Surgery
Official title: A Prospective Longitudinal Study of Severe Aortic Stenosis in Elderly and Outcome of Aortic Surgery.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Stenosis
Valvular Heart Disease
Symptomatic Aortic Stenosis
Keywords: HRQoL
Aortic stenosis
Aortic valve surgery
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2013-02-20
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

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 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.

Primary outcomes:
measure: Death due cardiovascular events
timeFrame: one year
Secondary outcomes:
measure: MACE ( Major cardiovascular events )
timeFrame: 30 days
Other outcomes:
measure: Change in Health related Quality and function one year after inclusion
timeFrame: one year
measure: Hospital visit and use of Health services last years
timeFrame: 30 days
Locations:
city: Oslo
country: Norway
facility: Oslo University hospital- Rikshospitalet
Study officials:
affiliation: University of Oslo
name: Kjell I Pettersen, MD
role: STUDY_DIRECTOR
affiliation: Oslo University Hosptial
name: Amjad I Hussain, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oslo University Hospital
name: Lars Gullestad, Professor
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.