Understanding patients with elevated pulmonary arterial pressure
| ISRCTN | ISRCTN34481181 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34481181 |
| IRAS number | 125796 |
| Secondary identifying numbers | IRAS 125796 |
- Submission date
- 12/04/2021
- Registration date
- 09/06/2021
- Last edited
- 19/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and aims:
Pulmonary Arterial Hypertension (PAH) is a serious, rare condition caused by a narrowing of the blood vessels (pulmonary artery) that connect the heart to the lungs. This leads to an increase in the pressure inside the pulmonary artery and therefore the heart has to work much harder to move blood through the lungs and body. A diagnosis of pulmonary hypertension occurs when the mean Pulmonary Arterial (PA) pressure is >25mmHg. Pulmonary hypertension is associated with a high chance of disability and death.
However, it is known a mean PA pressure of 21-24mmHg, is abnormal. With a better understanding of the abnormal haemodynamics effect on prognosis, there may be a better chance for clinicians to intervene earlier and change the overall progression of the disease. In this study patients with “mild/borderline” pulmonary hypertension will be identified and the progression of their disease will be studied to determine who might develop definite pulmonary hypertension. It is important to understand this patient group in greater detail. This will safely inform clinical decision making and help develop guidance for this patient cohort, who have abnormal haemodynamics, but do not fulfil the current definition of pulmonary hypertension.
Who can participate?
This study will include data from adult patients who have received multiple right heart catheter (RHC) procedures. Participants will not be approached to take part in this study as it is an observational study of past patient data.
What does the study involve?
This study will collect data of patient and clinical characteristics, biomarkers, therapies and prognosis from the period between 01/01/2009 and 01/03/2020 for patients who fulfil the eligibility criteria.
What are the possible benefits and risks of participating?
Though this study may not benefit participants whose data will be used, it may help researchers to understand this patient group in greater detail and to safely inform clinical decision making and help develop guidance for this patient cohort. No risks are anticipated as part of this study as it will look at past patient data only.
Where is the study run from?
The Royal Free London NHS Foundation Trust (UK) and will collect data from 7 UK hospital sites
When is the study starting and how long is it expected to run for?
From May 20219 to August 2021
Who is funding the study?
Actelion Pharmaceuticals Ltd (Switzerland)
Who is the main contact?
Dr Nina Karia
Rf.phphenotyping@nhs.net
Contact information
Scientific
Rheumatology Clinical Trials
Lower Ground Floor
Royal Free Hospital
Hampstead
London
NW3 2QG
United Kingdom
| Phone | +44 (0)2073177544 |
|---|---|
| gerry.coghlan@nhs.net |
Public
Rheumatology Clinical Trials
Lower Ground Floor
Royal Free Hospital
Hampstead
London
NW3 2QG
United Kingdom
| Phone | +44 (0)2073177544 |
|---|---|
| ivy.wanjiku@nhs.net |
Scientific
Rheumatology Clinical Trials
Lower Ground Floor
Royal Free Hospital
Hampstead
London
NW3 2QG
United Kingdom
| Phone | +44 (0)2073177544 |
|---|---|
| Nina.karia@nhs.net |
Study information
| Study design | Multicenter retrospective observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | No participant information sheet available |
| Scientific title | Phenotyping individuals with elevated mean pulmonary arterial pressure and elevated pulmonary vascular resistance in the United Kingdom |
| Study acronym | EVIDENCE-PAH |
| Study objectives | To understand the patient cohort, with “mild/borderline” pulmonary hypertension (pulmonary arterial pressure between 21 and24mmHg) who do not fulfil the current definition of pulmonary hypertension, and determine who might develop definite pulmonary hypertension, with the aim to safely inform clinical decision making and help develop guidance for this patient cohort. |
| Ethics approval(s) | Approved 23/03/2020, London - Harrow Research Ethics Committee (Level 3, Block B Whitefriars Lewins Mead Bristol BS1 2NT; +44 (0)207 104 8098; harrow.rec@hra.nhs.uk), ref: 20/LO/0344 |
| Health condition(s) or problem(s) studied | Pulmonary arterial hypertension |
| Intervention | This retrospective, observational, multi-center study aims to describe patient and clinical characteristics, biomarkers, therapies, and prognosis of patients categorized into 3 groups based on their Mean pulmonary arterial pressure (mPAP) (<21, ≥21-<25, or ≥25 mmHg) and Pulmonary vascular resistance (PVR) (<2, ≥2-<3, or ≥3 WU) measurements. In addition, quality of life, hospitalization, and mortality data (to be obtained from HES and ONS or ISD in Scotland) will be compared across patient cohorts. Research teams will collect data on approximately 2,000 patients who had previously undergone a Right Heart Catheterisation (RHC) procedure in one of the participating pulmonary hypertension (PH) specialist centers in a routine clinical practice setting during the eligibility period 01/01/2009 to 31/12/2017 and fulfilled all the inclusion criteria and none of the exclusion criteria. The first RHC will be the baseline point of data collection and will be compared to their annual follow-up visit data, which will be collected for a maximum of 11 years (01/03/2020) or until the patient's death. |
| Intervention type | Other |
| Primary outcome measure | 1. Hospitalization measured using the incidence of inpatient hospitalization events due to any cause anytime during the observation period (01/01/2009 to 01/03/2020) from retrospective HES and ONS or ISD data collection at a single timepoint 2. Mortality rates measured using the time to all-cause mortality anytime during the observation period (01/01/2009 to 01/03/2020) from retrospective HES and ONS or ISD data collection at a single timepoint |
| Secondary outcome measures | 1. Quality of life measured using the Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) or emPHasis-10 questionnaire anytime during the observation period (01/01/2009 to 01/03/2020) from retrospective HES and ONS or ISD data collection at a single timepoint 2. Progression to Pulmonary Hypertension measured using the date of Right Heart Catheterisation (RHC) anytime during the observation period (01/01/2009 to 01/03/2020) when the measured mPAP is ≥25 mmHg for the first time after the index RHC from retrospective HES and ONS or ISD data collection at a single timepoint |
| Overall study start date | 07/05/2019 |
| Completion date | 31/08/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 2000 |
| Key inclusion criteria | 1. Aged ≥18 years at time of the first right heart catheter (RHC) procedure within the eligibility period 2. ≥1 RHC procedure in one of the pulmonary hypertension specialist or approved centers within the eligibility period |
| Key exclusion criteria | 1. Missing value for mean Pulmonary Arterial Pressure or Pulmonary Vascular Resistance at the right heart catheter (RHC) procedure 2. Received any Pulmonary arterial hypertension medications before the first RHC procedure 3. Lung and/or heart transplant any time before the first RHC procedure 4. Enrolled in any interventional clinical trial with an investigational product within the 3 months prior to, or at the time of, the first RHC procedure within the eligibility period |
| Date of first enrolment | 01/01/2009 |
| Date of final enrolment | 01/03/2020 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
Hampstead
London
NW3 2QG
United Kingdom
White City
London
W12 0HS
United Kingdom
Chelsea
London
SW3 6NP
United Kingdom
Sheffield
S10 2JF
United Kingdom
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Cambridge
CB2 0AY
United Kingdom
Clydebank
Glasgow
G81 4DY
United Kingdom
Sponsor information
Hospital/treatment centre
Royal Free London NHS Foundation Trust
Pond Street
London
NW3 2QG
England
United Kingdom
| Phone | +44 (0)20 7794 0500 ext 36316 |
|---|---|
| rf.sponsoredresearch@nhs.net | |
| Website | http://www.royalfree.nhs.uk/ |
"ROR" |
https://ror.org/04rtdp853 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Actelion Pharmaceuticals Ltd
- Location
- Switzerland
Results and Publications
| Intention to publish date | 31/03/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository (PAH tool database). Aggregate data will be shared with study funder Actelion Pharmaceuticals at the end of the study. Consent from participants was not obtained as this would bias the data. Study was reviewed and approved under section 251 support by the Confidentiality Advisory Group, allowing for the processing of confidential patient information without consent. All study data will be anonymised. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version v3.0 | 05/11/2020 | 10/06/2021 | No | No |
| Protocol file | version v4.0 | 19/05/2021 | 01/07/2021 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 21/11/2023 | 19/07/2024 | Yes | No |
Additional files
- ISRCTN34481181_PROTOCOL_v3.0_05Nov2020.pdf
- Uploaded 10/06/2021
- ISRCTN34481181_PROTOCOL_v4.0_19May2021.pdf
- Uploaded 01/07/2021
Editorial Notes
19/07/2024: Publication reference added.
01/07/2021: The following changes have been made:
1. Uploaded protocol version 4.0, 19 May 2021 (not peer reviewed).
2. The acronym has been added.
10/06/2021: Internal review. Uploaded protocol version 3.0, 5 November 2020 (not peer reviewed).
08/06/2021: Trial’s existence confirmed by London - Harrow Research Ethics Committee.
