Patients With Heart Failure and Preserved Ejection Fraction - HFpEFDIAMONDHFpEFNCT03050593
Developing Imaging And plasMa biOmarkers iN Describing Heart Failure With Preserved Ejection Fraction (DIAMONDHFpEF)
An observational study of Patients With Heart Failure and Preserved Ejection Fraction - HFpEF and Patients With Heart Failure With Reduced Ejection Fraction - HFrEF, run by University of Leicester.
Trial summary
The investigators wish to test a hypothesis that patients with HFpEF have different characteristics on echo, cardiac MRI and plasma protein \& chemical profiles compared to HFrEF and healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patients With Heart Failure and Preserved Ejection Fraction - HFpEF, Patients With Heart Failure With Reduced Ejection Fraction - HFrEF, Healthy Controls Group - Age and Sex-matched
- What is being tested?
- MRI scan, Echo scan
- How many people
- 280 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to May 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects with heart failure from Hospital (including ward patients and out-patients clinic)
Who may be able to join
- Clinical features of heart failure or prior radiographic evidence in the absence of symptoms And Either ejection fraction > 50% (for HFpEF arm) or ejection fraction < 40% (for HFrEF arm)
Who cannot join
- Myocardial infarction within the preceding 6 months
- Suspected or confirmed cardiomyopathy (e.g. hypertrophic, infiltrative)
- Suspected or confirmed constrictive pericarditis
- Significant native valve disease (≥ moderate severity)
- Known Significant lung disease (documented or FEV1< 30% or FVC < 50%)
- Non-cardiovascular co-morbidity likely to cause death within 6 months (e.g. malignancy)
- Significant renal failure (estimated GFR < 30 ml/min/m2)
- Patient inability to provide informed consent (e.g. dementia)
About this study
Official title: Prospective, Observational, Single-centre, Cohort Study Aimed at Developing Imaging and Plasma Biomarkers in Heart Failure With Preserved Ejection Fraction
The investigators wish to test a hypothesis that patients with HFpEF have different characteristics on echo, cardiac MRI and plasma protein \& chemical profiles compared to HFrEF and healthy volunteers.
Read the detailed description
Large scale prospective studies incorporating cardiac MRI, echocardiography and plasma sampling are currently lacking in HFpEF. The main aims of our study are to:
- better phenotype and characterise HFpEF (also comparing with HFrEF and age- and sex- matched healthy controls)
- provide mechanistic insights into pathophysiology
- describe potential biomarkers and their relation to relevant clinical outcomes (exercise capacity, heart failure quality of life and prognosis)
- Conditions
- Patients With Heart Failure and Preserved Ejection Fraction - HFpEF, Patients With Heart Failure With Reduced Ejection Fraction - HFrEF, Healthy Controls Group - Age and Sex-matched
- Being tested
- MRI scan, Echo scan
- Keywords
- HFpEF, HFrEF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI scan, Echo scanDiagnostic test
Also called cardiac MRI, trans thoracic echocardiography
| Study group | Role | What they receive |
|---|---|---|
| HFpEF group | clinical or radiographic evidence of heart failure and left ventricular ejection fraction > 50% on transthoracic echocardiography Receives: Diagnostic Test: MRI scan, Echo scan | |
| HFrEF group | Clinical or radiographic evidence of heart failure and left ventricular ejection fraction < 40% on transthoracic echocardiography Receives: Diagnostic Test: MRI scan, Echo scan | |
| Healthy control group | Asymptomatic controls (age and sex-matched) without known heart disease Receives: Diagnostic Test: MRI scan, Echo scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
The composite end-point of all-cause mortality or repeat hospitalisation with heart failure
Measured: Minimum 6 month follow-up
Secondary outcomes (3)
The number of new clinical diagnoses detected by cardiac MRI
Measured: Through study completion, an average of 1 year
Exercise capacity as assessed by the six-minute walk test
Measured: Through study completion, an average of 1 year
Quality of life assessed by the Minnesota Living with Heart Failure Questionnaire
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2017
- Study startFeb 2013
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Patients With Heart Failure and Preserved Ejection Fraction - HFpEFStudies 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
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03050593
- Sponsor's protocol ID
- 0328
- Acronym
- DIAMONDHFpEF
- Status last verified
- May 2015
- First submitted
- 6 Feb 2017
- Last updated
- 13 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arnold JR, Kanagala P, Budgeon CA, Jerosch-Herold M, Gulsin GS, Singh A, Khan JN, Chan DCS, Squire IB, Ng LL, McCann GP. Prevalence and Prognostic Significance of Microvascular Dysfunction in Heart Failure With Preserved Ejection Fraction. JACC Cardiovasc Imaging. 2022 Jun;15(6):1001-1011. doi: 10.1016/j.jcmg.2021.11.022. Epub 2022 Jan 12.
PubMed 35033490Kanagala P, Arnold JR, Khan JN, Singh A, Gulsin GS, Chan DCS, Cheng ASH, Yang J, Li Z, Gupta P, Squire IB, McCann GP, Ng LL. Plasma Tenascin-C: a prognostic biomarker in heart failure with preserved ejection fraction. Biomarkers. 2020 Nov;25(7):556-565. doi: 10.1080/1354750X.2020.1810319. Epub 2020 Aug 28.
PubMed 32803990Kanagala P, Arnold JR, Singh A, Khan JN, Gulsin GS, Gupta P, Squire IB, Ng LL, McCann GP. Prevalence of right ventricular dysfunction and prognostic significance in heart failure with preserved ejection fraction. Int J Cardiovasc Imaging. 2021 Jan;37(1):255-266. doi: 10.1007/s10554-020-01953-y. Epub 2020 Jul 31.
PubMed 32737707Gulsin GS, Kanagala P, Chan DCS, Cheng ASH, Athithan L, Graham-Brown MPM, Singh A, Yang J, Li Z, Khunti K, Davies MJ, Arnold JR, Squire IB, Ng LL, McCann GP. Differential left ventricular and left atrial remodelling in heart failure with preserved ejection fraction patients with and without diabetes. Ther Adv Endocrinol Metab. 2019 Jul 5;10:2042018819861593. doi: 10.1177/2042018819861593. eCollection 2019.
PubMed 31308926Kanagala P, Cheng ASH, Singh A, Khan JN, Gulsin GS, Patel P, Gupta P, Arnold JR, Squire IB, Ng LL, McCann GP. Relationship Between Focal and Diffuse Fibrosis Assessed by CMR and Clinical Outcomes in Heart Failure With Preserved Ejection Fraction. JACC Cardiovasc Imaging. 2019 Nov;12(11 Pt 2):2291-2301. doi: 10.1016/j.jcmg.2018.11.031. Epub 2019 Feb 13.
PubMed 30772227Kanagala P, Cheng ASH, Singh A, McAdam J, Marsh AM, Arnold JR, Squire IB, Ng LL, McCann GP. Diagnostic and prognostic utility of cardiovascular magnetic resonance imaging in heart failure with preserved ejection fraction - implications for clinical trials. J Cardiovasc Magn Reson. 2018 Jan 11;20(1):4. doi: 10.1186/s12968-017-0424-9.
PubMed 29321034
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Observational, Single-centre, Cohort Study Aimed at Developing Imaging and Plasma Biomarkers in Heart Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT03050593
- Acronym / sponsor ID
- DIAMONDHFpEF / 0328
- Conditions
- Patients With Heart Failure and Preserved Ejection Fraction - HFpEF, Patients With Heart Failure With Reduced Ejection Fraction - HFrEF, Healthy Controls Group - Age and Sex-matched
- Keywords
- HFpEF, HFrEF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- Feb 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 13 Feb 2017 (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.
The investigators wish to test a hypothesis that patients with HFpEF have different characteristics on echo, cardiac MRI and plasma protein \& chemical profiles compared to HFrEF and healthy volunteers.
Detailed description
Large scale prospective studies incorporating cardiac MRI, echocardiography and plasma sampling are currently lacking in HFpEF. The main aims of our study are to:
- better phenotype and characterise HFpEF (also comparing with HFrEF and age- and sex- matched healthy controls)
- provide mechanistic insights into pathophysiology
- describe potential biomarkers and their relation to relevant clinical outcomes (exercise capacity, heart failure quality of life and prognosis)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HFpEF group | – | Diagnostic Test: MRI scan, Echo scanclinical or radiographic evidence of heart failure and left ventricular ejection fraction > 50% on transthoracic echocardiography |
| HFrEF group | – | Diagnostic Test: MRI scan, Echo scanClinical or radiographic evidence of heart failure and left ventricular ejection fraction < 40% on transthoracic echocardiography |
| Healthy control group | – | Diagnostic Test: MRI scan, Echo scanAsymptomatic controls (age and sex-matched) without known heart disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with heart failure from Hospital (including ward patients and out-patients clinic)
Key inclusion criteria (1 listed)
- Clinical features of heart failure or prior radiographic evidence in the absence of symptoms And Either ejection fraction > 50% (for HFpEF arm) or ejection fraction < 40% (for HFrEF arm)
Key exclusion criteria (8 listed)
- Myocardial infarction within the preceding 6 months
- Suspected or confirmed cardiomyopathy (e.g. hypertrophic, infiltrative)
- Suspected or confirmed constrictive pericarditis
- Significant native valve disease (≥ moderate severity)
- Known Significant lung disease (documented or FEV1< 30% or FVC < 50%)
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 |
|---|---|---|
| MRI scan, Echo scanAlso: cardiac MRI, trans thoracic echocardiography | Diagnostic test | HFpEF group, HFrEF group, Healthy control group |
Primary outcome
The composite end-point of all-cause mortality or repeat hospitalisation with heart failure
Time frame: Minimum 6 month follow-up
3 secondary outcomes
The number of new clinical diagnoses detected by cardiac MRI
Time frame: Through study completion, an average of 1 year
Exercise capacity as assessed by the six-minute walk test
Time frame: Through study completion, an average of 1 year
Quality of life assessed by the Minnesota Living with Heart Failure Questionnaire
Time frame: Through study completion, an average of 1 year
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 13 Feb 2017.
- Derived from this study: PubMed 35033490Arnold JR, Kanagala P, Budgeon CA, Jerosch-Herold M, Gulsin GS, Singh A, Khan JN, Chan DCS, Squire IB, Ng LL, McCann GP. Prevalence and Prognostic Significance of Microvascular Dysfunction in Heart Failure With Preserved Ejection Fraction. JACC Cardiovasc Imaging. 2022 Jun;15(6):1001-1011. doi: 10.1016/j.jcmg.2021.11.022. Epub 2022 Jan 12.
- Derived from this study: PubMed 32803990Kanagala P, Arnold JR, Khan JN, Singh A, Gulsin GS, Chan DCS, Cheng ASH, Yang J, Li Z, Gupta P, Squire IB, McCann GP, Ng LL. Plasma Tenascin-C: a prognostic biomarker in heart failure with preserved ejection fraction. Biomarkers. 2020 Nov;25(7):556-565. doi: 10.1080/1354750X.2020.1810319. Epub 2020 Aug 28.
- Derived from this study: PubMed 32737707Kanagala P, Arnold JR, Singh A, Khan JN, Gulsin GS, Gupta P, Squire IB, Ng LL, McCann GP. Prevalence of right ventricular dysfunction and prognostic significance in heart failure with preserved ejection fraction. Int J Cardiovasc Imaging. 2021 Jan;37(1):255-266. doi: 10.1007/s10554-020-01953-y. Epub 2020 Jul 31.
- Derived from this study: PubMed 31308926Gulsin GS, Kanagala P, Chan DCS, Cheng ASH, Athithan L, Graham-Brown MPM, Singh A, Yang J, Li Z, Khunti K, Davies MJ, Arnold JR, Squire IB, Ng LL, McCann GP. Differential left ventricular and left atrial remodelling in heart failure with preserved ejection fraction patients with and without diabetes. Ther Adv Endocrinol Metab. 2019 Jul 5;10:2042018819861593. doi: 10.1177/2042018819861593. eCollection 2019.
- Derived from this study: PubMed 30772227Kanagala P, Cheng ASH, Singh A, Khan JN, Gulsin GS, Patel P, Gupta P, Arnold JR, Squire IB, Ng LL, McCann GP. Relationship Between Focal and Diffuse Fibrosis Assessed by CMR and Clinical Outcomes in Heart Failure With Preserved Ejection Fraction. JACC Cardiovasc Imaging. 2019 Nov;12(11 Pt 2):2291-2301. doi: 10.1016/j.jcmg.2018.11.031. Epub 2019 Feb 13.
- Derived from this study: PubMed 29321034Kanagala P, Cheng ASH, Singh A, McAdam J, Marsh AM, Arnold JR, Squire IB, Ng LL, McCann GP. Diagnostic and prognostic utility of cardiovascular magnetic resonance imaging in heart failure with preserved ejection fraction - implications for clinical trials. J Cardiovasc Magn Reson. 2018 Jan 11;20(1):4. doi: 10.1186/s12968-017-0424-9.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With Heart Failure and Preserved Ejection Fraction - HFpEF and Patients With Heart Failure With Reduced Ejection Fraction - HFrEF, run by University of Leicester.
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 1 inclusion and 8 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 13 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The composite end-point of all-cause mortality or repeat hospitalisation with heart failure (time frame: Minimum 6 month follow-up). 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 NCT03050593, which also lists 6 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 13 Feb 2017.