Clinical trial NCT03617848: Optimising Management of Patients With Heart Failure With Preserved Ejection Fraction in Primary Care
Official title: Optimising Management of Patients With Heart Failure With Preserved Ejection Fraction in Primary Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure With Preserved Ejection Fraction
Keywords: HFpEF
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Oxford
name: Keele University
name: University of Manchester
First posted: 2018-08-07
Enrollment: 153
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult males and females with suspected Heart Failure with Preserved Ejection fraction

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Morbidity
timeFrame: 1 year from recruitment
measure: Mortality
timeFrame: 1 year from recruitment
Secondary outcomes:
measure: Kansas City Cardiomyopathy Questionnaire
timeFrame: Baseline, 6 & 12 months
measure: 6 Minute Walk Test
timeFrame: baseline to 6 & 12 months
measure: Montreal Cognitive Assessment (MOCA)
timeFrame: baseline to 6 & 12 months
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospital NHS Foundation Trust
Study officials:
affiliation: Cambridge University Hospitals NHS FT
name: Christi Deaton, PhD,RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.