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Completed

NCT Number: NCT03617848

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

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cambridge University Hospital NHS Foundation Trust

Cambridge, United Kingdom

About this study

This work package of the study will use phenotyping and one-year follow-up of a community recruited cohort of patients with HFpEF or probable HFpEF to understand the characteristics and needs of this patient group. It involves a longitudinal cohort study conducted to identify patients with HFpEF in primary care and assess comorbidities, lifestyle factors, frailty, self-management, symptoms, quality of life, cognitive function, types of care received, management of risk factors and comorbidities, and one year morbidity and mortality. This will inform particular areas for assessment and management/self-management in the optimised programme. The investigators will also apply to NHS Digital who are the data controllers of Hospital Episode Statistics to check if participants have had any hospitals visits throughout the duration of the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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)

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Morbidity

    Time frame: 1 year from recruitment

    Episodes of diseases

  2. Mortality

    Time frame: 1 year from recruitment

    Confirmed death during follow-up

Secondary outcomes

  1. Kansas City Cardiomyopathy Questionnaire

    Time frame: Baseline, 6 & 12 months

    Heart failure specific quality of life over time (transformed total score 0 - 100); higher scores indicate better quality of life. 5 point change considered clinically relevant.

  2. 6 Minute Walk Test

    Time frame: baseline to 6 & 12 months

    physical function changes over time

  3. Montreal Cognitive Assessment (MOCA)

    Time frame: baseline to 6 & 12 months

    cognitive function over time

Sponsors and collaborators

Lead sponsor

Professor Christi Deaton

Other

Collaborators

  • Keele University
  • University of Manchester
  • University of Oxford

Registry information

Acronym: OPTIMISEHFpEF

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Aug 7, 2018
Registry last updated
Feb 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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