Developing Imaging And plasMa biOmarkers iN Describing Heart Failure With Preserved Ejection Fraction (DIAMONDHFpEF)
NCT ID: NCT03050593
Last Updated: 2017-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
280 participants
OBSERVATIONAL
2013-02-28
2015-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
CMR Assessment of Cardiac Microvascular Dysfunction in Patients With HFpEF
NCT06316661
Diagnosis and OutcoMes evaluAtIoN of Multicenter Patients With HFpEF Using Multimodality Imaging
NCT04602338
Manganese-enhanced Magnetic Resonance Imaging (MEMRI) in Heart Failure With Preserved Ejection Fraction
NCT06652763
Heart Failure With Preserved Ejection Fraction: Evaluation and Recognition by CMR
NCT05114785
Multimodality Imaging in the Screening, Diagnosis and Risk StratifictiON of HFpEF
NCT04603404
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
1. better phenotype and characterise HFpEF (also comparing with HFrEF and age- and sex- matched healthy controls)
2. provide mechanistic insights into pathophysiology
3. describe potential biomarkers and their relation to relevant clinical outcomes (exercise capacity, heart failure quality of life and prognosis)
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
HFpEF group
clinical or radiographic evidence of heart failure and left ventricular ejection fraction \> 50% on transthoracic echocardiography
MRI scan, Echo scan
HFrEF group
Clinical or radiographic evidence of heart failure and left ventricular ejection fraction \< 40% on transthoracic echocardiography
MRI scan, Echo scan
Healthy control group
Asymptomatic controls (age and sex-matched) without known heart disease
MRI scan, Echo scan
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MRI scan, Echo scan
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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)
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute for Health Research, United Kingdom
OTHER_GOV
University of Leicester
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Kanagala 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.
Kanagala 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.
Gulsin 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.
Kanagala 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.
Kanagala 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
0328
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.