Cardiac SarcoidosisNCT05145023
Development and Validation of a Health-related Quality of Life Tool for Patients With Cardiac Sarcoidosis
An observational study of Cardiac Sarcoidosis, run by Queen Mary University of London at 2 sites in United Kingdom.
Trial summary
What is the purpose of this research? This study includes two parts based in two NHS specialist centres for cardiac sarcoidosis: Development of the CARD-SARC: Development of the new questionnaire to measure quality of life in cardiac sarcoidosis patients (the CARD-SARC questionnaire) Validation of the CARD-SARC… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Cardiac Sarcoidosis
- How many people
- 130 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 11 Nov 2021to 31 Dec 2025
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Using the WASOG criteria, participants will be adult patients attending the Outpatients Department with a probable (50-90% likelihood) or highly probable (>90% likelihood) diagnosis of cardiac sarcoidosis (CS) by a multidisciplinary team meeting in a CS-specialist centre.
Who may be able to join
- Adult (≥ 18 years)
- Patients with a probable (50-90% likelihood) or highly probable (>90% likelihood) diagnosis of cardiac sarcoidosis (CS) by a multidisciplinary team meeting in a CS-specialist centre as per the WASOG criteria
- Patients attending outpatient clinics in a CS-specialist centre
Who cannot join
- Unable or unwilling to give informed consent
- Unable or unwilling to give and/or complete the study questionnaires • Inability to understand written and/or verbal English
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Royal Papworth Hospital NHS Foundation Trust
Cambridge, CB20AY
St Bartholomew's Hospital - Barts Health NHS Trust
London, EC1A 7DN
About this study
What is the purpose of this research?
This study includes two parts based in two NHS specialist centres for cardiac sarcoidosis:
- Development of the CARD-SARC: Development of the new questionnaire to measure quality of life in cardiac sarcoidosis patients (the CARD-SARC questionnaire)
- Validation of the CARD-SARC: Evaluation of how good the CARD-SARC questionnaire is at measuring quality of life changes in patients with cardiac sarcoidosis.
Read the detailed description
What would taking part involve?
First, we would like to talk with a group of patients (between 6 to 20) about the impact of cardiac sarcoidosis in their quality of life during an interview. We will review and analysed these interviews. Then, we will compare with what is already know about cardiac sarcoidosis and its impact on quality of life. Also, we will ask healthcare professionals working with cardiac sarcoidosis patients to review our results. Finally, we will use this information to create the first draft of the new questionnaire (CARD-SARC questionnaire)to measure quality of life in cardiac sarcoidosis patients.
Second, we will ask 20 patients with cardiac sarcoidosis to complete the draft version of the CARD-SARC questionnaire. Also, they will complete validated quality of life questionnaires (for general population or sarcoidosis patients) and questionnaires that explore potential symptoms of fatigue, anxiety and depression. We will compare an review these results to confirm that the CARD-SARC questionnaire is ready for evaluation.
Third, we will ask 100 cardiac sarcoidosis patients to complete the CARD-SARC questionnaire and the validated questionnaires (for quality of life and potential sarcoidosis symptoms) to evaluate how good the CARD-SARC is at measuring quality of life changes in cardiac sarcoidosis patients.
How will patients or the public help guide the research?
This work has been influenced and designed with people living with cardiac sarcoidosis. SarcoidosisUK, the UK sarcoidosis charity, has been supportive and engaged on this work. Likewise, five expert patients with cardiac sarcoidosis have also agreed to lead, contribute and advice on relevant aspects of the study, and to participate sharing the results to the public, patients and professional groups.
- Conditions
- Cardiac Sarcoidosis
- Keywords
- cardiac sarcoidosis, health-related quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Development of the CARD-SARC (n=20) | * Interviews: 6-20 participants (depending of data saturation) will be recruited using a convenience sampling strategy. * Field-testing: 20 participants using a convenience/consecutive sampling strategy. | |
| Validation of the CARD-SARC (n=100) | The CS-specialist centres (Barts Health NHS Trust and Royal Papworth Hospital NHS Foundation Trust) have a cohort of 60-70 potential candidates in each site. The estimated sample size for the Pilot-testing is 100 study participants, considering previous sarcoidosis studies including PROMs, with less than 10% population declining participation or failing to complete their questionnaires. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To develop and validate a disease-specific HRQoL tool (CARD-SARC) for people diagnosed with cardiac sarcoidosis.
Patient-related research activities include semi-structured interviews for item generation (McMaster framework step 1 - item selection), field-testing for the development of the CARD-SARC questionnaire (McMaster framework step 3 - item reduction) and a pilot-testing for the validation of the CARD-SARC (steps 4-6 - determination of reliability, validity and responsiveness).
Measured: 12 months
Secondary outcomes (8)
The CARD-SARC questionnaire (new HRQoL-questionnaire for cardiac sarcoidosis).
To determine reliability, validity and responsiveness of the CARD-SARC:
- Internal consistency to determine if the CARD-SARC can be used as questionnaire to measure longitudinal changes in HRQoL in CS patients.
- Test-retest reliability to determine the concordance of two separated self-administration of the CARD-SARC.
- Longitudinal construct validity to determine the correlation between changes in the CARD-SARC and an external measure over time.
- Index of responsiveness for the CARD-SARC.
The CARD-SARC will be self-completed by participants at baseline and weeks 2,12,24,52.
Measured: 12 months
The 5-Levels of severity for the EuroQoL 5- Dimensions (EQ5D-5L) questionnaire.
This is a generic HRQoL/health status questionnaire. The EQ5D-5 consists of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each with five levels of health response and a visual analogue scale (VAS) ranging from 0-100 (0 being the worst possible health imaginable and 100 being the best possible health imaginable). The EQ5D-5L will be self-completed by participants at baseline and weeks 2,12,24,52 to assess HRQoL in CS patients using two standardised HRQoL-tools (EQ5D-5L and SF-36).
Measured: 12 months
The Short-form 36 (SF-36) questionnaire.
This is a generic HRQoL/health status questionnaire. The SF-36 consists in eight scales eight dimension to measure two components: physical and mental summary scores ranging from 0-100. The physical component summary (PCS) includes physical functioning (10-items), role physical (4-items), bodily pain (2-items), general health (5-items). The mental component summary (MCS) includes vitality (4-items), social functioning (2-items), role emotional (3-items), mental health (5-items). Individual scores (0-100) can be obtained by weighted sums of the questions for each of the eight domains. The SF-36 will be self-completed by participants at baseline and weeks 2,12,24,52 to assess HRQoL in CS patients using two standardised HRQoL-tools (EQ5D-5L and SF-36).
Measured: 12 months
The Sarcoidosis Health Questionnaire (SHQ) questionnaire.
This is a sarcoidosis-specific HRQoL questionnaire. The SHQ contains 29-items covering three domains: daily functioning, physical functioning, and emotional functioning. The responses range from "all of the time" (score of 1) to "none of the time" (score of 7). Higher score indicate better HRQoL. The SHQ will be self-completed by participants at baseline and weeks 2,12,24,52 to compare HRQoL in CS patients using three (non-cardiac) sarcoidosis-specific PROMs (SHQ, KSQ and SAT).
Measured: 12 months
The King's Sarcoidosis Questionnaire (KSQ) questionnaire.
This is a sarcoidosis-specific HRQoL questionnaire. The KSQ contains 29-item covering five modules: general HRQoL (10- items), medications (3-items), lung (6-items), skin (3-items) and eyes (7- items). The KSQ is scored a re-ordered response scale ranging from 1 ("all of the time" or "a huge amount") to 7 ("none of the time" or "none at all"). The KSQ will be self-completed by participants at baseline and weeks 2,12,24,52 to compare HRQoL in CS patients using three (non-cardiac) sarcoidosis-specific PROMs (SHQ, KSQ and SAT).
Measured: 12 months
The Sarcoidosis Assessment Tool (SAT).
This is a sarcoidosis-specific HRQoL questionnaire. The formatted version of the SAT contains 51-items covering components for physical functioning, satisfaction with roles and activities, fatigue, pain interference, sleep disturbance, sarcoidosis-lung concerns, sarcoidosis-skin concerns, and sarcoidosis-skin stigma. The responses ranging from 1 to 5 with different response options ("not at all" to "very much"; "unable to do" to "without any difficulty"; or "never" to "always"). The SAT will be self-completed by participants at baseline and weeks 2,12,24,52 to compare HRQoL in CS patients using three (non-cardiac) sarcoidosis-specific PROMs (SHQ, KSQ and SAT).
Measured: 12 months
The Fatigue Assessment Scale (FAS).
The FAS is a one-dimensional fatigue questionnaire reflecting on physical (5-items) and mental fatigue (5-items). Each item has a five-point rating scare, ranging from "1-never" to "5-always". The score of FAS ranges from 10-50, with a well-defined cut-off for fatigue of >21 points. The FAS will be self-completed (optional) by participants at baseline and weeks 2,12,24,52 to assess fatigue in CS patients.
Measured: 12 months
The Hospital Anxiety and Depression Scale (HADS).
The HADS is 14-item scale on a 4-point Likert scale (0-3) containing two subscales for anxiety and depression (7 items each subscale). The total score for each subscale is the sum of the respective items (ranging from 0-21). The HADS will be self-completed (optional) by participants at baseline and weeks 2,12,24,52 to assess anxiety and depression in CS patients.
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 posted6 Dec 2021
- Study start11 Nov 2021
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SarcoidosisStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- 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
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- Barts & The London NHS Trust, Papworth Hospital NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05145023
- Sponsor's protocol ID
- 143251
- Other IDs
- 256815
- Status last verified
- Feb 2026
- First submitted
- 16 Nov 2021
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Health-related Quality of Life Tool for Patients With Cardiac Sarcoidosis
- ClinicalTrials.gov ID
- NCT05145023
- Acronym / sponsor ID
- 143251
- Conditions
- Cardiac Sarcoidosis
- Keywords
- cardiac sarcoidosis, health-related quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- Barts & The London NHS Trust, Papworth Hospital NHS Foundation Trust
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 6 Dec 2021 (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.
What is the purpose of this research?
This study includes two parts based in two NHS specialist centres for cardiac sarcoidosis:
- Development of the CARD-SARC: Development of the new questionnaire to measure quality of life in cardiac sarcoidosis patients (the CARD-SARC questionnaire)
- Validation of the CARD-SARC: Evaluation of how good the CARD-SARC questionnaire is at measuring quality of life changes in patients with cardiac sarcoidosis.
Detailed description
What would taking part involve?
First, we would like to talk with a group of patients (between 6 to 20) about the impact of cardiac sarcoidosis in their quality of life during an interview. We will review and analysed these interviews. Then, we will compare with what is already know about cardiac sarcoidosis and its impact on quality of life. Also, we will ask healthcare professionals working with cardiac sarcoidosis patients to review our results. Finally, we will use this information to create the first draft of the new questionnaire (CARD-SARC questionnaire)to measure quality of life in cardiac sarcoidosis patients.
Second, we will ask 20 patients with cardiac sarcoidosis to complete the draft version of the CARD-SARC questionnaire. Also, they will complete validated quality of life questionnaires (for general population or sarcoidosis patients) and questionnaires that explore potential symptoms of fatigue, anxiety and depression. We will compare an review these results to confirm that the CARD-SARC questionnaire is ready for evaluation.
Third, we will ask 100 cardiac sarcoidosis patients to complete the CARD-SARC questionnaire and the validated questionnaires (for quality of life and potential sarcoidosis symptoms) to evaluate how good the CARD-SARC is at measuring quality of life changes in cardiac sarcoidosis patients.
How will patients or the public help guide the research?
This work has been influenced and designed with people living with cardiac sarcoidosis. SarcoidosisUK, the UK sarcoidosis charity, has been supportive and engaged on this work. Likewise, five expert patients with cardiac sarcoidosis have also agreed to lead, contribute and advice on relevant aspects of the study, and to participate sharing the results to the public, patients and professional groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Development of the CARD-SARC (n=20) | – | –* Interviews: 6-20 participants (depending of data saturation) will be recruited using a convenience sampling strategy. * Field-testing: 20 participants using a convenience/consecutive sampling strategy. |
| Validation of the CARD-SARC (n=100) | – | –The CS-specialist centres (Barts Health NHS Trust and Royal Papworth Hospital NHS Foundation Trust) have a cohort of 60-70 potential candidates in each site. The estimated sample size for the Pilot-testing is 100 study participants, considering previous sarcoidosis studies including PROMs, with less than 10% population declining participation or failing to complete their questionnaires. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Using the WASOG criteria, participants will be adult patients attending the Outpatients Department with a probable (50-90% likelihood) or highly probable (>90% likelihood) diagnosis of cardiac sarcoidosis (CS) by a multidisciplinary team meeting in a CS-specialist centre.
Key inclusion criteria (3 listed)
- Adult (≥ 18 years)
- Patients with a probable (50-90% likelihood) or highly probable (>90% likelihood) diagnosis of cardiac sarcoidosis (CS) by a multidisciplinary team meeting in a CS-specialist centre as per the WASOG criteria
- Patients attending outpatient clinics in a CS-specialist centre
Key exclusion criteria (2 listed)
- Unable or unwilling to give informed consent
- Unable or unwilling to give and/or complete the study questionnaires • Inability to understand written and/or verbal English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To develop and validate a disease-specific HRQoL tool (CARD-SARC) for people diagnosed with cardiac sarcoidosis.
Time frame: 12 months
Patient-related research activities include semi-structured interviews for item generation (McMaster framework step 1 - item selection), field-testing for the development of the CARD-SARC questionnaire (McMaster framework step 3 - item reduction) and a pilot-testing for the validation of the CARD-SARC (steps 4-6 - determination of reliability, validity and responsiveness).
8 secondary outcomes
The CARD-SARC questionnaire (new HRQoL-questionnaire for cardiac sarcoidosis).
Time frame: 12 months
The 5-Levels of severity for the EuroQoL 5- Dimensions (EQ5D-5L) questionnaire.
Time frame: 12 months
The Short-form 36 (SF-36) questionnaire.
Time frame: 12 months
The Sarcoidosis Health Questionnaire (SHQ) questionnaire.
Time frame: 12 months
The King's Sarcoidosis Questionnaire (KSQ) questionnaire.
Time frame: 12 months
The Sarcoidosis Assessment Tool (SAT).
Time frame: 12 months
The Fatigue Assessment Scale (FAS).
Time frame: 12 months
The Hospital Anxiety and Depression Scale (HADS).
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 2 Mar 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Sarcoidosis, run by Queen Mary University of London at 2 sites 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 2 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 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
To develop and validate a disease-specific HRQoL tool (CARD-SARC) for people diagnosed with cardiac sarcoidosis. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Mar 2026.