Severe Aortic Stenosis in Patients Referred for Valve Surgery

NCT ID: NCT01794832

Last Updated: 2014-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2014-06-30

Brief Summary

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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

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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.

Conditions

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Aortic Stenosis Valvular Heart Disease Symptomatic Aortic Stenosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Elderly with severe aortic stenosis

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Amjad Iqbal Hussain

Md

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kjell I Pettersen, MD

Role: STUDY_DIRECTOR

University of Oslo

Amjad I Hussain, MD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hosptial

Lars Gullestad, Professor

Role: STUDY_CHAIR

Oslo University Hospital

Locations

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Oslo University hospital- Rikshospitalet

Oslo, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Amjad I Hussain, Md

Role: CONTACT

0047 98043412

Facility Contacts

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Lars Gullestad, professor

Role: primary

References

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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.

Reference Type DERIVED
PMID: 32962417 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30613413 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29746650 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28977361 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26994130 (View on PubMed)

Other Identifiers

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SAS

Identifier Type: -

Identifier Source: org_study_id

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