Aortic Valve StenosisQUACSNCT04231461
Quality of Life After Cardiac Surgery
An observational study of Aortic Valve Stenosis and Mitral Valve Disease, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
During the last twenty years heart surgery has become safer and the number of patients having heart surgery has increased with more frail patients being offered increasingly complex surgery. Heart operations often improve survival and quality of life (QoL), but that is not true for all patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Mitral Valve Disease, Tricuspid Valve Disease
- What is being tested?
- Cardiac Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 2,925 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Jul 2019to 21 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adults able to understand the patient information sheet written in English.
Who may be able to join
- EuroSCORE II ≥ 3% or EuroSCORE logistic of ≥ 6%
- Patients undergoing routine/ urgent cardiac surgery
- Patients must have the ability to provide informed consent
Who cannot join
- Patients undergoing salvage or emergency operations
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Papworth Hospital
Cambridge, Cambridgeshire, CB2 0AY
About this study
During the last twenty years heart surgery has become safer and the number of patients having heart surgery has increased with more frail patients being offered increasingly complex surgery. Heart operations often improve survival and quality of life (QoL), but that is not true for all patients. Regarding survival, clinicians can measure the risk to life from having a heart operation and the risk to life from not quite precisely, but clinicians have little idea about the impact of heart operations on QoL, which is the outcome that patients care about most. Clinicians are unable to provide patients with robust information on how an operation will affect their QoL. This study will provide this information by analysing the data from patient questionnaires immediately before and after the procedure and monthly thereafter for 12 months.
Read the detailed description
The Sponsor shall use existing questionnaires to measure QoL in patients having major heart surgery. QoL will be measured before the operation and monthly afterwards for 12 months in order to answer the following questions:
- How does having heart surgery affect the QoL immediately after the operation?
- How long does it take patients to return to the same quality of life they had before the surgery?
- How long does it take patients to regain any loss of quality of life due to the operation? Does quality of life improve thereafter?
- What proportion of patients will achieve a net benefit in QoL?
- Are there features that can predict who will benefit in terms of QoL and who will not? The Sponsor will use the data to develop an electronic calculator to enable quick and robust evaluation of the impact of heart surgery on the QoL of individuals. Patients will then be able to give truly informed consent and to decide if they wish have surgery based on a full knowledge of both surgical risk and the potential impact on QoL.
- Conditions
- Aortic Valve Stenosis, Mitral Valve Disease, Tricuspid Valve Disease, Aorta Disease, Coronary Artery Bypass Graft
- Being tested
- Cardiac Surgery
- Medical subject headings
- Aortic Valve Stenosis, Aortic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac SurgeryProcedure or surgery
Also called Aortic Valve Procedure, Mitral Valve Procedure, Tricuspid Valve Procedure, Procedure on Aorta
Routine or urgent cardiac surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Life using Questionnaire EQ-5D
Conduct questionnaire EQ-5D to assess Quality of Life Change post major cardiac surgery procedure. These questionnaires ask patients to assess their levels of pain, mobility, anxiety and depression to give an overall Quality of Life Measure.
Measured: 12 Months
Secondary outcomes (1)
Change in Quality of Life using Questionnaire SF-12
Conduct questionnaire SF-12 to assess Quality of Life Change post major cardiac surgery procedure. These questionnaires ask patients to assess their levels of pain, mobility, anxiety and depression to give an overall Quality of Life Measure.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start19 Jul 2019
- Primary completion30 Apr 2024
- Study completion21 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,925 participants (actual)
Sponsor and investigators
- Lead sponsor
- Papworth Hospital NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Samer Nashef, Study director, Chief Investigator Royal Papworth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04231461
- Sponsor's protocol ID
- P02500
- Acronym
- QUACS
- Status last verified
- Nov 2024
- First submitted
- 12 Sep 2019
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data is not to be shared with researchers
Publications
Nashef SAM, Willard J, Mills C, Chiu YD, Noyes P, Petch MC, Couturier DL, Large SR. Quality of Life After Cardiac Surgery: The QUACS Study and Benefit Prediction Model. Eur J Cardiothorac Surg. 2026 May 11;68(5):ezag159. doi: 10.1093/ejcts/ezag159.
PubMed 42118099
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04231461
- Acronym / sponsor ID
- QUACS / P02500
- Conditions
- Aortic Valve Stenosis, Mitral Valve Disease, Tricuspid Valve Disease, Aorta Disease, Coronary Artery Bypass Graft
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,925 participants (actual)
- Lead sponsor
- Papworth Hospital NHS Foundation TrustOther government
- Study start
- 19 Jul 2019 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 21 May 2024 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
During the last twenty years heart surgery has become safer and the number of patients having heart surgery has increased with more frail patients being offered increasingly complex surgery. Heart operations often improve survival and quality of life (QoL), but that is not true for all patients. Regarding survival, clinicians can measure the risk to life from having a heart operation and the risk to life from not quite precisely, but clinicians have little idea about the impact of heart operations on QoL, which is the outcome that patients care about most. Clinicians are unable to provide patients with robust information on how an operation will affect their QoL. This study will provide this information by analysing the data from patient questionnaires immediately before and after the procedure and monthly thereafter for 12 months.
Detailed description
The Sponsor shall use existing questionnaires to measure QoL in patients having major heart surgery. QoL will be measured before the operation and monthly afterwards for 12 months in order to answer the following questions:
- How does having heart surgery affect the QoL immediately after the operation?
- How long does it take patients to return to the same quality of life they had before the surgery?
- How long does it take patients to regain any loss of quality of life due to the operation? Does quality of life improve thereafter?
- What proportion of patients will achieve a net benefit in QoL?
- Are there features that can predict who will benefit in terms of QoL and who will not? The Sponsor will use the data to develop an electronic calculator to enable quick and robust evaluation of the impact of heart surgery on the QoL of individuals. Patients will then be able to give truly informed consent and to decide if they wish have surgery based on a full knowledge of both surgical risk and the potential impact on QoL.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adults able to understand the patient information sheet written in English.
Key inclusion criteria (3 listed)
- EuroSCORE II ≥ 3% or EuroSCORE logistic of ≥ 6%
- Patients undergoing routine/ urgent cardiac surgery
- Patients must have the ability to provide informed consent
Key exclusion criteria (1 listed)
- Patients undergoing salvage or emergency operations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac SurgeryAlso: Aortic Valve Procedure, Mitral Valve Procedure, Tricuspid Valve Procedure, Procedure on AortaRoutine or urgent cardiac surgery | Procedure or surgery | – |
Primary outcome
Change in Quality of Life using Questionnaire EQ-5D
Time frame: 12 Months
Conduct questionnaire EQ-5D to assess Quality of Life Change post major cardiac surgery procedure. These questionnaires ask patients to assess their levels of pain, mobility, anxiety and depression to give an overall Quality of Life Measure.
1 secondary outcome
Change in Quality of Life using Questionnaire SF-12
Time frame: 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Derived from this study: PubMed 42118099Nashef SAM, Willard J, Mills C, Chiu YD, Noyes P, Petch MC, Couturier DL, Large SR. Quality of Life After Cardiac Surgery: The QUACS Study and Benefit Prediction Model. Eur J Cardiothorac Surg. 2026 May 11;68(5):ezag159. doi: 10.1093/ejcts/ezag159.
- Individual participant dataSharing planned: No. Participant data is not to be shared with researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samer Nashef study director
Chief Investigator Royal Papworth Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis and Mitral Valve Disease, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of Life using Questionnaire EQ-5D (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04231461, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.