10-year Follow-up After Aortic Valve Replacement Surgery

NCT06255691 | Not Yet Recruiting

• 1 other identifier: 23596
• Study Type: observational
• Target: 282
• Locations: 0 countries
• Sites: N/A

Brief Summary

There is a lack of data on patients self-reported outcomes (PROMs) on health-related quality of life (HRQoL)and symptoms on anxiety and depression 10 years after Surgical After Aortic Valve Replacement (SAVR), and patient reported experiences with the health services (PREMS). In this 10-years follow-up study on patients alive from the study named "The Impact of 24/ 7-phone Support on Readmission After Aortic Valve Replacement, a Randomized Clinical Trial (AVRre)" NCT02522663 we will repeat the survey on symtoms on anxiety and depresion using Hospital Anxiety and depression Scale (HADS), health-related quality of life (EQ-5D) and questions about experiences with the health services.

Conditions

Aortic Stenosis; Anxiety; Depressive Symptoms; Quality of Life

Keywords

aortic valve replacement; longitudinal study; patient reported outcome; symptoms of anxiety; health-related quality of life

Outcome Measures

Primary Outcomes (2)

• Symptoms of anxiety and depression

  Symptoms of anxiety and depression measured by Hospital Anxiety and Depression Scale (HADS)

  10 year follow-up

• Health related quality of life

  EQ-5D-3L questionnaire from The EuroQol Group to measure health related quality of life.

  10 year follow-up

Secondary Outcomes (1)

• Experiences with health services

  10 year follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

10 year follow-up of the participants in the AVrRe study

You may qualify if:

• Treatment with AVR (biological or mechanical) single, AVR (b or m)+aortocoronary bypass, AVR (b or m)+supra coronary tube graft Can understand, speak and write native Language (norwegian), and be able to fill in the questionnaires

You may not qualify if:

• Patients not alive after the AVRre study

Sponsors & Collaborators

• Oslo University Hospital: lead
• Oslo Metropolitan University: collaborator

MeSH Terms

Conditions

Aortic Valve Stenosis; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Stein Ove O Danielsen, PhD

  OsloMet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stein O Danielsen, PhD

CONTACT

4741368255; steinove@oslomet.no

Irene Lie, PhD

CONTACT

99026729; Irene.lie@ous-hf.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: February 4, 2024
• First Posted: February 13, 2024
• Study Start: April 10, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 13, 2024

Record last verified: 2024-02