Developing Imaging And plasMa biOmarkers iN Describing Heart Failure With Preserved Ejection Fraction (DIAMONDHFpEF)

NCT ID: NCT03050593

Last Updated: 2017-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

280 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2015-05-31

Brief Summary

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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

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Large scale prospective studies incorporating cardiac MRI, echocardiography and plasma sampling are currently lacking in HFpEF. The main aims of our study are to:

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

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HFpEF group

clinical or radiographic evidence of heart failure and left ventricular ejection fraction \> 50% on transthoracic echocardiography

MRI scan, Echo scan

Intervention Type DIAGNOSTIC_TEST

HFrEF group

Clinical or radiographic evidence of heart failure and left ventricular ejection fraction \< 40% on transthoracic echocardiography

MRI scan, Echo scan

Intervention Type DIAGNOSTIC_TEST

Healthy control group

Asymptomatic controls (age and sex-matched) without known heart disease

MRI scan, Echo scan

Intervention Type DIAGNOSTIC_TEST

Interventions

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MRI scan, Echo scan

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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cardiac MRI, trans thoracic echocardiography

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role collaborator

University of Leicester

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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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.

Reference Type DERIVED
PMID: 35033490 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32803990 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32737707 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31308926 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30772227 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29321034 (View on PubMed)

Other Identifiers

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0328

Identifier Type: -

Identifier Source: org_study_id

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