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

Completed

• Conditions: Heart Failure With Preserved Ejection Fraction

• Registration Number: NCT03617848
• Lead Sponsor: Professor Christi Deaton

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.

Study Timeline

• Study Start: 2018-07-17
• Study First Submitted: 2018-07-31
• Study First Submitted QC: 2018-08-06
• Study First Posted: 2018-08-07
• Primary Completion: 2020-11-30
• Study Completion: 2021-03-30
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-14
• Last Update Posted: 2022-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Morbidity	1 year from recruitment	Episodes of diseases
Mortality	1 year from recruitment	Confirmed death during follow-up

Secondary Outcome Measures

Name	Time	Method
Kansas City Cardiomyopathy Questionnaire	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.
6 Minute Walk Test	baseline to 6 & 12 months	physical function changes over time
Montreal Cognitive Assessment (MOCA)	baseline to 6 & 12 months	cognitive function over time

Trial Locations

Locations (1)

Cambridge University Hospital NHS Foundation Trust; 🇬🇧 Cambridge, United Kingdom