Clinical trial NCT03050593: Developing Imaging And plasMa biOmarkers iN Describing Heart Failure With Preserved Ejection Fraction (DIAMONDHFpEF)
Official title: Prospective, Observational, Single-centre, Cohort Study Aimed at Developing Imaging and Plasma Biomarkers in Heart Failure With Preserved Ejection Fraction
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: University of Leicester
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2017-02-13
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with heart failure from Hospital (including ward patients and out-patients clinic)

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.

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:

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)

Eligibility criteria: 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)

Primary outcomes:
measure: The composite end-point of all-cause mortality or repeat hospitalisation with heart failure
timeFrame: Minimum 6 month follow-up
Secondary outcomes:
measure: The number of new clinical diagnoses detected by cardiac MRI
timeFrame: Through study completion, an average of 1 year
measure: Exercise capacity as assessed by the six-minute walk test
timeFrame: Through study completion, an average of 1 year
measure: Quality of life assessed by the Minnesota Living with Heart Failure Questionnaire
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.