Heart Failure With Preserved Ejection FractionNCT04233086
Retrospective Observational Analysis of a Cohort With Heart Failure With Preserved Ejection Fraction
An observational study of Heart Failure With Preserved Ejection Fraction, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Heart failure with preserved ejection fraction (HFpEF) is a complex condition with various causes that is not yet fully understood. Most significantly there is no single method of diagnosing or treating the condition. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction
- How many people
- 500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Feb 2020to 3 Apr 2020
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All participants will be patients who have attended heart failure clinics at QAH between 01/01/2016 - 31/12/2016. Eligibility will be met by the inclusion and exclusion criteria.
Who may be able to join
- Age 18-95yrs inclusive
- Currently or previously attended a heart failure clinic with a cardiology consultant at QAH
- Had an echocardiogram, ECG, BNP blood biomarker test in addition to a routine clinical evaluation (including age, weight and number of hypertensive medications) during January 1st 2016 - December 31st 2016.
Who cannot join
- Known structural heart disease
- Significant heart valve disease (greater than mild stenosis, greater than moderate regurgitation)
- Pulmonary arterial hypertension
- Constrictive pericarditis
- Pre-existing cardiomyopathy
- Heart transplantation
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Portsmouth University Hospital
Portsmouth, Hampshire, PO63LY
About this study
Official title: A Retrospective Observational Analysis of a Cohort With Heart Failure With Preserved Ejection Fraction From a BNP Pathway Clinic
Heart failure with preserved ejection fraction (HFpEF) is a complex condition with various causes that is not yet fully understood. Most significantly there is no single method of diagnosing or treating the condition. Recently a novel non-invasive diagnostic criterion to predict the likelihood of HFpEF was proposed called H2FPEF. The main limitation of this study was the use of a single centre population from the Mayo clinic in Rochester, US. Another limitation is that the H2FPEF diagnostic criterion consists of common and often co-existing conditions which could as a result overestimate HFpEF probability. The aim of the investigators is to retrospectively test the H2FPEF criteria on the population at Queen Alexandra Hospital (QAH) in Portsmouth, which is of a lower socio-economic status and greater ethnic diversity. Implications of the proposed project if H2FPEF is proved to be generalizable to the study population is that it can be used within the Trust and rolled out to others. This would allow diagnosis to be made quicker and more cost effectively using echocardiography and without the need for invasive cardiac catheterisation. On the other hand if H2FPEF is found not to be applicable to the population then further research would be required to find the ideal diagnostic tool.
Read the detailed description
HFpEF was previously characterised as 'diastolic dysfunction' but this terminology was changed as it was found that diastolic dysfunction was also seen in patients with 'systolic dysfunction'. Myocardial stiffness which leads to increased filling pressures is a common pathophysiologic attribute of HFpEF despite its multifactorial aetiology. Other common conditions associated with HFpEF include: atrial fibrillation (AF), chronotropic incompetence, pulmonary hypertension, right ventricular dysfunction and endothelial dysfunction; with common non-specific risk factors such as: age, gender, hypertension, obesity, diabetes, metabolic syndrome and renal failure. This complex heterogeneity of HFpEF which is not yet fully understood highlights the difficulty that clinicians have in being able to diagnose the condition.
Diagnosis of HFpEF is difficult and as of yet there is no test to confirm diagnosis, with current guidelines saying initial diagnosis should include the presence of typical signs and symptoms, an elevated B-type natriuretic peptide (BNP) (>35 pg/mL and/or N-Terminal pro-B-type Natriuretic Peptide [NT-proBNP] >125 pg/mL) and ejection fraction ≥50%. Echocardiography is the preferred method of assessing for HFpEF due to it being widely available, non-invasive, and able to provide immediate results. Recent studies comparing the use of echocardiography against 'gold standard' invasive cardiac catheterisation to assess cardiac filling pressures found echocardiography to be just as accurate and reliable. Implications of this research would be that patients could be assessed as outpatients by focus echocardiography rather than invasively in the cardiac catheterisation lab, which would improve patient experience, enhance patient outcomes and prove cost-effective for trusts.
In response a recently proposed non-invasive diagnostic criteria called H2FPEF which assesses patients based on body mass index (BMI), the number of hypertensive medications they take, presence of AF, pulmonary pressure, age and filling pressure. The advantage of the H2FPEF score is that it uses only non-invasive echocardiography data alongside routine clinical data making it easy to derive. However one key limitation of their study is the population they used was all from the Mayo clinic and so the generalisability of their results has not been tested for other populations, such as those of lower socioeconomic status like in Portsmouth. A further limitation is the parameters chosen to create H2FPEF are all relatively common morbidities and usually co-exist, making it likely that it will over diagnose HFpEF.
- Being tested
- No intervention, observational only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention, observational onlyOther
No intervention, observational only
| Study group | Role | What they receive |
|---|---|---|
| Patients referred through the BNP pathway | Patients throughout 2016 referred through the BNP pathway at Queen Alexandra Hospital will retrospectively be assessed for Reddy et al (2018) H2FPEF score. Receives: Other: No intervention, observational only |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the predictive and diagnostic accuracy of H2FPEF at predicting HFpEF on our patient population
Predictive accuracy calculated with logistic regression and diagnostic accuracy with specificity and sensitivity calculations
Measured: February - April 2020
Secondary outcomes (2)
Follow-up of patient outcomes - Hospital admissions
To assess number of hospital admissions after one year for the study population.
Measured: February - April 2020
Follow-up of patient outcomes - Change in treatment
To assess any changes in treatment after one year for the study population.
Measured: February - April 2020
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 start3 Feb 2020
- Primary completion3 Apr 2020
- Study completion3 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portsmouth Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- Manchester Metropolitan University
- Responsible party
- Sponsor
- Investigators
- Kaushik Guha, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04233086
- Sponsor's protocol ID
- 262060
- Status last verified
- Apr 2023
- First submitted
- 7 Jan 2020
- Last updated
- 7 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No participant data will be shared under the Data Protection Act. Only overall results of the statistical analyses will be shared.
Publications
Borlaug BA, Paulus WJ. Heart failure with preserved ejection fraction: pathophysiology, diagnosis, and treatment. Eur Heart J. 2011 Mar;32(6):670-9. doi: 10.1093/eurheartj/ehq426. Epub 2010 Dec 7.
PubMed 21138935Telles F, Marwick TH. Imaging and Management of Heart Failure and Preserved Ejection Fraction. Curr Treat Options Cardiovasc Med. 2018 Sep 27;20(11):90. doi: 10.1007/s11936-018-0689-9.
PubMed 30259312Borlaug BA. The pathophysiology of heart failure with preserved ejection fraction. Nat Rev Cardiol. 2014 Sep;11(9):507-15. doi: 10.1038/nrcardio.2014.83. Epub 2014 Jun 24.
PubMed 24958077Ferrari R, Bohm M, Cleland JG, Paulus WJ, Pieske B, Rapezzi C, Tavazzi L. Heart failure with preserved ejection fraction: uncertainties and dilemmas. Eur J Heart Fail. 2015 Jul;17(7):665-71. doi: 10.1002/ejhf.304. Epub 2015 Jun 16.
PubMed 26079097Harper AR, Patel HC, Lyon AR. Heart failure with preserved ejection fraction. Clin Med (Lond). 2018 Apr 1;18(Suppl 2):s24-s29. doi: 10.7861/clinmedicine.18-2-s24.
PubMed 29700089Lekavich CL, Barksdale DJ, Neelon V, Wu JR. Heart failure preserved ejection fraction (HFpEF): an integrated and strategic review. Heart Fail Rev. 2015 Nov;20(6):643-53. doi: 10.1007/s10741-015-9506-7.
PubMed 26404098Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available.
PubMed 27206819Reddy YNV, Carter RE, Obokata M, Redfield MM, Borlaug BA. A Simple, Evidence-Based Approach to Help Guide Diagnosis of Heart Failure With Preserved Ejection Fraction. Circulation. 2018 Aug 28;138(9):861-870. doi: 10.1161/CIRCULATIONAHA.118.034646.
PubMed 29792299Andersen OS, Smiseth OA, Dokainish H, Abudiab MM, Schutt RC, Kumar A, Sato K, Harb S, Gude E, Remme EW, Andreassen AK, Ha JW, Xu J, Klein AL, Nagueh SF. Estimating Left Ventricular Filling Pressure by Echocardiography. J Am Coll Cardiol. 2017 Apr 18;69(15):1937-1948. doi: 10.1016/j.jacc.2017.01.058.
PubMed 28408024Lancellotti P, Galderisi M, Edvardsen T, Donal E, Goliasch G, Cardim N, Magne J, Laginha S, Hagendorff A, Haland TF, Aaberge L, Martinez C, Rapacciuolo A, Santoro C, Ilardi F, Postolache A, Dulgheru R, Mateescu AD, Beladan CC, Deleanu D, Marchetta S, Auffret V, Schwammenthal E, Habib G, Popescu BA. Echo-Doppler estimation of left ventricular filling pressure: results of the multicentre EACVI Euro-Filling study. Eur Heart J Cardiovasc Imaging. 2017 Sep 1;18(9):961-968. doi: 10.1093/ehjci/jex067.
PubMed 28444160
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Observational Analysis of a Cohort With Heart Failure With Preserved Ejection Fraction From a BNP Pathway Clinic
- ClinicalTrials.gov ID
- NCT04233086
- Acronym / sponsor ID
- 262060
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Portsmouth Hospitals NHS TrustOther government
- Collaborators
- Manchester Metropolitan University
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 3 Apr 2020 (actual)
- Study completion
- 3 Apr 2020 (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.
Heart failure with preserved ejection fraction (HFpEF) is a complex condition with various causes that is not yet fully understood. Most significantly there is no single method of diagnosing or treating the condition. Recently a novel non-invasive diagnostic criterion to predict the likelihood of HFpEF was proposed called H2FPEF. The main limitation of this study was the use of a single centre population from the Mayo clinic in Rochester, US. Another limitation is that the H2FPEF diagnostic criterion consists of common and often co-existing conditions which could as a result overestimate HFpEF probability. The aim of the investigators is to retrospectively test the H2FPEF criteria on the population at Queen Alexandra Hospital (QAH) in Portsmouth, which is of a lower socio-economic status and greater ethnic diversity. Implications of the proposed project if H2FPEF is proved to be generalizable to the study population is that it can be used within the Trust and rolled out to others. This would allow diagnosis to be made quicker and more cost effectively using echocardiography and without the need for invasive cardiac catheterisation. On the other hand if H2FPEF is found not to be applicable to the population then further research would be required to find the ideal diagnostic tool.
Detailed description
HFpEF was previously characterised as 'diastolic dysfunction' but this terminology was changed as it was found that diastolic dysfunction was also seen in patients with 'systolic dysfunction'. Myocardial stiffness which leads to increased filling pressures is a common pathophysiologic attribute of HFpEF despite its multifactorial aetiology. Other common conditions associated with HFpEF include: atrial fibrillation (AF), chronotropic incompetence, pulmonary hypertension, right ventricular dysfunction and endothelial dysfunction; with common non-specific risk factors such as: age, gender, hypertension, obesity, diabetes, metabolic syndrome and renal failure. This complex heterogeneity of HFpEF which is not yet fully understood highlights the difficulty that clinicians have in being able to diagnose the condition.
Diagnosis of HFpEF is difficult and as of yet there is no test to confirm diagnosis, with current guidelines saying initial diagnosis should include the presence of typical signs and symptoms, an elevated B-type natriuretic peptide (BNP) (>35 pg/mL and/or N-Terminal pro-B-type Natriuretic Peptide [NT-proBNP] >125 pg/mL) and ejection fraction ≥50%. Echocardiography is the preferred method of assessing for HFpEF due to it being widely available, non-invasive, and able to provide immediate results. Recent studies comparing the use of echocardiography against 'gold standard' invasive cardiac catheterisation to assess cardiac filling pressures found echocardiography to be just as accurate and reliable. Implications of this research would be that patients could be assessed as outpatients by focus echocardiography rather than invasively in the cardiac catheterisation lab, which would improve patient experience, enhance patient outcomes and prove cost-effective for trusts.
In response a recently proposed non-invasive diagnostic criteria called H2FPEF which assesses patients based on body mass index (BMI), the number of hypertensive medications they take, presence of AF, pulmonary pressure, age and filling pressure. The advantage of the H2FPEF score is that it uses only non-invasive echocardiography data alongside routine clinical data making it easy to derive. However one key limitation of their study is the population they used was all from the Mayo clinic and so the generalisability of their results has not been tested for other populations, such as those of lower socioeconomic status like in Portsmouth. A further limitation is the parameters chosen to create H2FPEF are all relatively common morbidities and usually co-exist, making it likely that it will over diagnose HFpEF.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients referred through the BNP pathway | – | Other: No intervention, observational onlyPatients throughout 2016 referred through the BNP pathway at Queen Alexandra Hospital will retrospectively be assessed for Reddy et al (2018) H2FPEF score. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All participants will be patients who have attended heart failure clinics at QAH between 01/01/2016 - 31/12/2016. Eligibility will be met by the inclusion and exclusion criteria.
Key inclusion criteria (3 listed)
- Age 18-95yrs inclusive
- Currently or previously attended a heart failure clinic with a cardiology consultant at QAH
- Had an echocardiogram, ECG, BNP blood biomarker test in addition to a routine clinical evaluation (including age, weight and number of hypertensive medications) during January 1st 2016 - December 31st 2016.
Key exclusion criteria (6 listed)
- Known structural heart disease
- Significant heart valve disease (greater than mild stenosis, greater than moderate regurgitation)
- Pulmonary arterial hypertension
- Constrictive pericarditis
- Pre-existing cardiomyopathy
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 |
|---|---|---|
| No intervention, observational onlyNo intervention, observational only | Other | Patients referred through the BNP pathway |
Primary outcome
To assess the predictive and diagnostic accuracy of H2FPEF at predicting HFpEF on our patient population
Time frame: February - April 2020
Predictive accuracy calculated with logistic regression and diagnostic accuracy with specificity and sensitivity calculations
2 secondary outcomes
Follow-up of patient outcomes - Hospital admissions
Time frame: February - April 2020
Follow-up of patient outcomes - Change in treatment
Time frame: February - April 2020
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 7 Apr 2023.
- Background: PubMed 21138935Borlaug BA, Paulus WJ. Heart failure with preserved ejection fraction: pathophysiology, diagnosis, and treatment. Eur Heart J. 2011 Mar;32(6):670-9. doi: 10.1093/eurheartj/ehq426. Epub 2010 Dec 7.
- Background: PubMed 30259312Telles F, Marwick TH. Imaging and Management of Heart Failure and Preserved Ejection Fraction. Curr Treat Options Cardiovasc Med. 2018 Sep 27;20(11):90. doi: 10.1007/s11936-018-0689-9.
- Background: PubMed 24958077Borlaug BA. The pathophysiology of heart failure with preserved ejection fraction. Nat Rev Cardiol. 2014 Sep;11(9):507-15. doi: 10.1038/nrcardio.2014.83. Epub 2014 Jun 24.
- Background: PubMed 26079097Ferrari R, Bohm M, Cleland JG, Paulus WJ, Pieske B, Rapezzi C, Tavazzi L. Heart failure with preserved ejection fraction: uncertainties and dilemmas. Eur J Heart Fail. 2015 Jul;17(7):665-71. doi: 10.1002/ejhf.304. Epub 2015 Jun 16.
- Background: PubMed 29700089Harper AR, Patel HC, Lyon AR. Heart failure with preserved ejection fraction. Clin Med (Lond). 2018 Apr 1;18(Suppl 2):s24-s29. doi: 10.7861/clinmedicine.18-2-s24.
- Background: PubMed 26404098Lekavich CL, Barksdale DJ, Neelon V, Wu JR. Heart failure preserved ejection fraction (HFpEF): an integrated and strategic review. Heart Fail Rev. 2015 Nov;20(6):643-53. doi: 10.1007/s10741-015-9506-7.
- Background: PubMed 27206819Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available.
- Results publication: PubMed 29792299Reddy YNV, Carter RE, Obokata M, Redfield MM, Borlaug BA. A Simple, Evidence-Based Approach to Help Guide Diagnosis of Heart Failure With Preserved Ejection Fraction. Circulation. 2018 Aug 28;138(9):861-870. doi: 10.1161/CIRCULATIONAHA.118.034646.
- Results publication: PubMed 28408024Andersen OS, Smiseth OA, Dokainish H, Abudiab MM, Schutt RC, Kumar A, Sato K, Harb S, Gude E, Remme EW, Andreassen AK, Ha JW, Xu J, Klein AL, Nagueh SF. Estimating Left Ventricular Filling Pressure by Echocardiography. J Am Coll Cardiol. 2017 Apr 18;69(15):1937-1948. doi: 10.1016/j.jacc.2017.01.058.
- Results publication: PubMed 28444160Lancellotti P, Galderisi M, Edvardsen T, Donal E, Goliasch G, Cardim N, Magne J, Laginha S, Hagendorff A, Haland TF, Aaberge L, Martinez C, Rapacciuolo A, Santoro C, Ilardi F, Postolache A, Dulgheru R, Mateescu AD, Beladan CC, Deleanu D, Marchetta S, Auffret V, Schwammenthal E, Habib G, Popescu BA. Echo-Doppler estimation of left ventricular filling pressure: results of the multicentre EACVI Euro-Filling study. Eur Heart J Cardiovasc Imaging. 2017 Sep 1;18(9):961-968. doi: 10.1093/ehjci/jex067.
- Individual participant dataSharing planned: No. No participant data will be shared under the Data Protection Act. Only overall results of the statistical analyses will be shared.
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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.
Kaushik Guha principal investigator
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 Portsmouth Hospitals NHS 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 6 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 7 Apr 2023. 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?
To assess the predictive and diagnostic accuracy of H2FPEF at predicting HFpEF on our patient population (time frame: February - April 2020). 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 NCT04233086, which also lists 10 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 7 Apr 2023.