Heart Failure With Preserved Ejection FractionOPTIMISEHFpEFNCT03617848
Optimising Management of Patients With Heart Failure With Preserved Ejection Fraction in Primary Care
An observational study of Heart Failure With Preserved Ejection Fraction, run by Professor Christi Deaton at 1 site in United Kingdom.
Trial summary
Heart failure (HF) accounts for 2% of National Health Service (NHS) expenditure, and 5% of emergency hospitalisations. Patients with HF with preserved ejection fraction (HFpEF) are older, have more comorbidities, have similarly poor or worse outcomes compared to patients with reduced ejection fraction (HFrEF), and… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction
- How many people
- 153 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Jul 2018to 30 Mar 2021
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult males and females with suspected Heart Failure with Preserved Ejection fraction
Who may be able to join
- Adult patients with diagnosed or suspected HFpEF (defined as: patients diagnosed with non-valvular HF that are i) not diagnosed with left ventricular systolic dysfunction or have a documented ejection fraction < 50%; or ii) do have a reported 'normal' or preserved EF, documented EF > 50%, or reported diastolic dysfunction without moderate to severe systolic dysfunction) who:
- Have stable Class I - III New York Heart Association (NYHA) classification for chronic heart failure
- Have not been hospitalised for an exacerbation of their heart failure in the 6 weeks prior to screening
- Are able to communicate in English (both verbally and in writing)
Who cannot join
- Any patients who have:
- Any severe neuro-psychological or neuro-cognitive conditions that would confound outcome assessment
- NYHA Class IV classification for chronic heart failure receiving end of life care, or other life-threatening condition
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cambridge University Hospital NHS Foundation Trust
Cambridge
About this study
Heart failure (HF) accounts for 2% of National Health Service (NHS) expenditure, and 5% of emergency hospitalisations. Patients with HF with preserved ejection fraction (HFpEF) are older, have more comorbidities, have similarly poor or worse outcomes compared to patients with reduced ejection fraction (HFrEF), and currently lack an evidence base for treatment. The investigators hypothesise that outcomes of patients with HFpEF can be improved through optimised management and self-management of comorbidities, fluid status and lifestyle delivered in primary care in collaboration with specialists. The primary aim is to develop a programme of optimised management by improving understanding of needs and experiences of patients with HFpEF, clinical decision-making and management in primary care, and integrating research findings with patient and clinical expertise. The main objective for this work package is to identify patients with HFpEF in primary care and assess comorbidities and other factors, management, morbidity and mortality at one year. The methodology employed will be a longitudinal cohort study of 270 patients with HFpEF in primary care followed for 12 months.
Read the detailed description
This work package of the study will use phenotyping and one-year follow-up of a community recruited cohort of patients with HFpEF or probable HFpEF to understand the characteristics and needs of this patient group. It involves a longitudinal cohort study conducted to identify patients with HFpEF in primary care and assess comorbidities, lifestyle factors, frailty, self-management, symptoms, quality of life, cognitive function, types of care received, management of risk factors and comorbidities, and one year morbidity and mortality. This will inform particular areas for assessment and management/self-management in the optimised programme. The investigators will also apply to NHS Digital who are the data controllers of Hospital Episode Statistics to check if participants have had any hospitals visits throughout the duration of the study.
- Keywords
- HFpEF
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 |
|---|---|---|
| Cohort | A cohort of participants with suspected stable HFpEF will be recruited from the primary care setting. HFpEF diagnosis will be confirmed as per the 2016 European Society of Cardiology (ESC) guidelines for diagnosing HFpEF. All participants will undergo a series of assessments including but not limited to pulse wave velocity, 6 minute walk test, blood tests including natriuretic peptides (NT-Pro-BNP), ECG, physical assessments and a series of questionnaires. Those with confirmed HFpEF will be followed up at 6 and 12 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity
Episodes of diseases
Measured: 1 year from recruitment
Mortality
Confirmed death during follow-up
Measured: 1 year from recruitment
Secondary outcomes (3)
Kansas City Cardiomyopathy Questionnaire
Heart failure specific quality of life over time (transformed total score 0 - 100); higher scores indicate better quality of life. 5 point change considered clinically relevant.
Measured: Baseline, 6 & 12 months
6 Minute Walk Test
physical function changes over time
Measured: baseline to 6 & 12 months
Montreal Cognitive Assessment (MOCA)
cognitive function over time
Measured: baseline to 6 & 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start17 Jul 2018
- Primary completion30 Nov 2020
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Preserved Ejection FractionStudies 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
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Professor Christi Deaton
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford, Keele University, University of Manchester
- Responsible party
- Sponsor-investigator, Professor Christi Deaton, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Christi Deaton, PhD,RN, Principal investigator, Cambridge University Hospitals NHS FT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03617848
- Sponsor's protocol ID
- 234872
- Acronym
- OPTIMISEHFpEF
- Status last verified
- Feb 2022
- First submitted
- 31 Jul 2018
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Austin R, Khair E, Blakeman T, Hossain MZ, Sowden E, Chew-Graham C, Forsyth F, Deaton C; Optimise HFpEF Investigators; Optimise HFpEF Investigators. Diagnosing and managing patients with heart failure with preserved ejection fraction: a consensus survey. BMJ Open. 2024 Dec 20;14(12):e092993. doi: 10.1136/bmjopen-2024-092993.
PubMed 39806710Hossain MZ, Chew-Graham CA, Sowden E, Blakeman T, Wellwood I, Tierney S, Deaton C. Challenges in the management of people with heart failure with preserved ejection fraction (HFpEF) in primary care: A qualitative study of general practitioner perspectives. Chronic Illn. 2022 Jun;18(2):410-425. doi: 10.1177/1742395320983871. Epub 2021 Jan 5.
PubMed 33401942
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimising Management of Patients With Heart Failure With Preserved Ejection Fraction in Primary Care
- ClinicalTrials.gov ID
- NCT03617848
- Acronym / sponsor ID
- OPTIMISEHFpEF / 234872
- Keywords
- HFpEF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Professor Christi DeatonUniversity, hospital or other
- Collaborators
- University of Oxford, Keele University, University of Manchester
- Study start
- 17 Jul 2018 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 7 Aug 2018 (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.
Heart failure (HF) accounts for 2% of National Health Service (NHS) expenditure, and 5% of emergency hospitalisations. Patients with HF with preserved ejection fraction (HFpEF) are older, have more comorbidities, have similarly poor or worse outcomes compared to patients with reduced ejection fraction (HFrEF), and currently lack an evidence base for treatment. The investigators hypothesise that outcomes of patients with HFpEF can be improved through optimised management and self-management of comorbidities, fluid status and lifestyle delivered in primary care in collaboration with specialists. The primary aim is to develop a programme of optimised management by improving understanding of needs and experiences of patients with HFpEF, clinical decision-making and management in primary care, and integrating research findings with patient and clinical expertise. The main objective for this work package is to identify patients with HFpEF in primary care and assess comorbidities and other factors, management, morbidity and mortality at one year. The methodology employed will be a longitudinal cohort study of 270 patients with HFpEF in primary care followed for 12 months.
Detailed description
This work package of the study will use phenotyping and one-year follow-up of a community recruited cohort of patients with HFpEF or probable HFpEF to understand the characteristics and needs of this patient group. It involves a longitudinal cohort study conducted to identify patients with HFpEF in primary care and assess comorbidities, lifestyle factors, frailty, self-management, symptoms, quality of life, cognitive function, types of care received, management of risk factors and comorbidities, and one year morbidity and mortality. This will inform particular areas for assessment and management/self-management in the optimised programme. The investigators will also apply to NHS Digital who are the data controllers of Hospital Episode Statistics to check if participants have had any hospitals visits throughout the duration of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | –A cohort of participants with suspected stable HFpEF will be recruited from the primary care setting. HFpEF diagnosis will be confirmed as per the 2016 European Society of Cardiology (ESC) guidelines for diagnosing HFpEF. All participants will undergo a series of assessments including but not limited to pulse wave velocity, 6 minute walk test, blood tests including natriuretic peptides (NT-Pro-BNP), ECG, physical assessments and a series of questionnaires. Those with confirmed HFpEF will be followed up at 6 and 12 months. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult males and females with suspected Heart Failure with Preserved Ejection fraction
Key inclusion criteria (4 listed)
- Adult patients with diagnosed or suspected HFpEF (defined as: patients diagnosed with non-valvular HF that are i) not diagnosed with left ventricular systolic dysfunction or have a documented ejection fraction < 50%; or ii) do have a reported 'normal' or preserved EF, documented EF > 50%, or reported diastolic dysfunction without moderate to severe systolic dysfunction) who:
- Have stable Class I - III New York Heart Association (NYHA) classification for chronic heart failure
- Have not been hospitalised for an exacerbation of their heart failure in the 6 weeks prior to screening
- Are able to communicate in English (both verbally and in writing)
Key exclusion criteria (3 listed)
- Any severe neuro-psychological or neuro-cognitive conditions that would confound outcome assessment
- NYHA Class IV classification for chronic heart failure receiving end of life care, or other life-threatening condition
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
Morbidity
Time frame: 1 year from recruitment
Episodes of diseases
Mortality
Time frame: 1 year from recruitment
Confirmed death during follow-up
3 secondary outcomes
Kansas City Cardiomyopathy Questionnaire
Time frame: Baseline, 6 & 12 months
6 Minute Walk Test
Time frame: baseline to 6 & 12 months
Montreal Cognitive Assessment (MOCA)
Time frame: baseline to 6 & 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 15 Feb 2022.
- Derived from this study: PubMed 39806710Austin R, Khair E, Blakeman T, Hossain MZ, Sowden E, Chew-Graham C, Forsyth F, Deaton C; Optimise HFpEF Investigators; Optimise HFpEF Investigators. Diagnosing and managing patients with heart failure with preserved ejection fraction: a consensus survey. BMJ Open. 2024 Dec 20;14(12):e092993. doi: 10.1136/bmjopen-2024-092993.
- Derived from this study: PubMed 33401942Hossain MZ, Chew-Graham CA, Sowden E, Blakeman T, Wellwood I, Tierney S, Deaton C. Challenges in the management of people with heart failure with preserved ejection fraction (HFpEF) in primary care: A qualitative study of general practitioner perspectives. Chronic Illn. 2022 Jun;18(2):410-425. doi: 10.1177/1742395320983871. Epub 2021 Jan 5.
- Study websiteLink provided by the sponsor.
- 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.
Christi Deaton, PhD,RN principal investigator
Cambridge University Hospitals NHS FT
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 Heart Failure With Preserved Ejection Fraction, run by Professor Christi Deaton 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 4 inclusion and 3 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 15 Feb 2022. 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?
Morbidity (time frame: 1 year from recruitment). The study lists 2 primary outcomes in all. 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 NCT03617848, which also lists 2 linked publications.
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 15 Feb 2022.