Optimising Management of Patients With Heart Failure With Preserved Ejection Fraction in Primary Care

NCT03617848 | Completed DMC

• 1 other identifier: 234872
• Study Type: observational
• Target: 153
• Locations: 1 country
• Sites: 1

Brief Summary

Heart failure (HF) accounts for 2% of National Health Service (NHS) expenditure, and 5% of emergency hospitalisations. Patients with HF with preserved ejection fraction (HFpEF) are older, have more comorbidities, have similarly poor or worse outcomes compared to patients with reduced ejection fraction (HFrEF), and currently lack an evidence base for treatment. The investigators hypothesise that outcomes of patients with HFpEF can be improved through optimised management and self-management of comorbidities, fluid status and lifestyle delivered in primary care in collaboration with specialists. The primary aim is to develop a programme of optimised management by improving understanding of needs and experiences of patients with HFpEF, clinical decision-making and management in primary care, and integrating research findings with patient and clinical expertise. The main objective for this work package is to identify patients with HFpEF in primary care and assess comorbidities and other factors, management, morbidity and mortality at one year. The methodology employed will be a longitudinal cohort study of 270 patients with HFpEF in primary care followed for 12 months.

Conditions

Heart Failure With Preserved Ejection Fraction

Keywords

HFpEF

Outcome Measures

Primary Outcomes (2)

• Morbidity

  Episodes of diseases

  1 year from recruitment

• Mortality

  Confirmed death during follow-up

  1 year from recruitment

Secondary Outcomes (3)

• Kansas City Cardiomyopathy Questionnaire

  Baseline, 6 & 12 months

• 6 Minute Walk Test

  baseline to 6 & 12 months

• Montreal Cognitive Assessment (MOCA)

  baseline to 6 & 12 months

Study Arms (1)

Cohort

A cohort of participants with suspected stable HFpEF will be recruited from the primary care setting. HFpEF diagnosis will be confirmed as per the 2016 European Society of Cardiology (ESC) guidelines for diagnosing HFpEF. All participants will undergo a series of assessments including but not limited to pulse wave velocity, 6 minute walk test, blood tests including natriuretic peptides (NT-Pro-BNP), ECG, physical assessments and a series of questionnaires. Those with confirmed HFpEF will be followed up at 6 and 12 months.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult males and females with suspected Heart Failure with Preserved Ejection fraction

You may qualify if:

• Adult patients with diagnosed or suspected HFpEF (defined as: patients diagnosed with non-valvular HF that are i) not diagnosed with left ventricular systolic dysfunction or have a documented ejection fraction \< 50%; or ii) do have a reported 'normal' or preserved EF, documented EF \> 50%, or reported diastolic dysfunction without moderate to severe systolic dysfunction) who:
• Have stable Class I - III New York Heart Association (NYHA) classification for chronic heart failure
• Have not been hospitalised for an exacerbation of their heart failure in the 6 weeks prior to screening
• Are able to communicate in English (both verbally and in writing)

You may not qualify if:

• Any patients who have:
• Any severe neuro-psychological or neuro-cognitive conditions that would confound outcome assessment
• NYHA Class IV classification for chronic heart failure receiving end of life care, or other life-threatening condition

Sponsors & Collaborators

• Professor Christi Deaton: lead
• University of Oxford: collaborator
• Keele University: collaborator
• University of Manchester: collaborator

Study Sites (1)

Cambridge University Hospital NHS Foundation Trust

Cambridge, United Kingdom

Location

Related Publications (2)

• Austin R, Khair E, Blakeman T, Hossain MZ, Sowden E, Chew-Graham C, Forsyth F, Deaton C; Optimise HFpEF Investigators; Optimise HFpEF Investigators. Diagnosing and managing patients with heart failure with preserved ejection fraction: a consensus survey. BMJ Open. 2024 Dec 20;14(12):e092993. doi: 10.1136/bmjopen-2024-092993.

  PMID: 39806710 DERIVED

• Hossain MZ, Chew-Graham CA, Sowden E, Blakeman T, Wellwood I, Tierney S, Deaton C. Challenges in the management of people with heart failure with preserved ejection fraction (HFpEF) in primary care: A qualitative study of general practitioner perspectives. Chronic Illn. 2022 Jun;18(2):410-425. doi: 10.1177/1742395320983871. Epub 2021 Jan 5.

  PMID: 33401942 DERIVED

Related Links

• Study website

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma will be retained for future analysis as novel biomarkers emerge

Study Officials

• Christi Deaton, PhD,RN

  Cambridge University Hospitals NHS FT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Christi Deaton

Study Record Dates

• First Submitted: July 31, 2018
• First Posted: August 7, 2018
• Study Start: July 17, 2018
• Primary Completion: November 30, 2020
• Study Completion: March 30, 2021
• Last Updated: February 15, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)