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

NCT03050593 | Completed

• 1 other identifier: 0328
• Study Type: observational
• Target: 280
• Locations: 0 countries
• Sites: N/A

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• The composite end-point of all-cause mortality or repeat hospitalisation with heart failure

  Minimum 6 month follow-up

Secondary Outcomes (3)

• The number of new clinical diagnoses detected by cardiac MRI

  Through study completion, an average of 1 year

• Exercise capacity as assessed by the six-minute walk test

  Through study completion, an average of 1 year

• Quality of life assessed by the Minnesota Living with Heart Failure Questionnaire

  Through study completion, an average of 1 year

Study Arms (3)

HFpEF group

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

Diagnostic Test: MRI scan, Echo scan

HFrEF group

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

Diagnostic Test: MRI scan, Echo scan

Healthy control group

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

Diagnostic Test: MRI scan, Echo scan

Interventions

MRI scan, Echo scan DIAGNOSTIC_TEST

Also known as: cardiac MRI, trans thoracic echocardiography

HFpEF group; HFrEF group; Healthy control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects with heart failure from Hospital (including ward patients and out-patients clinic)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Leicester: lead
• National Institute for Health Research, United Kingdom: collaborator

Related Publications (6)

• 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.

  PMID: 35033490 DERIVED

• 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.

  PMID: 32803990 DERIVED

• 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.

  PMID: 32737707 DERIVED

• 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.

  PMID: 31308926 DERIVED

• 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.

  PMID: 30772227 DERIVED

• 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.

  PMID: 29321034 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

EDTA Plasma, serum, urine, DNA

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2017
• First Posted: February 13, 2017
• Study Start: February 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: February 13, 2017

Record last verified: 2015-05

Data Sharing

• IPD Sharing: Will not share