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

Heart Failure With Preserved Ejection Fraction Clinical Trial

— OPTIMISEHFpEF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03617848
• Other study ID #: 234872
• Status: Completed
• Start date: July 17, 2018
• Est. completion date: March 30, 2021

Study information

• Verified date: February 2022
• Source: Cambridge University Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: March 30, 2021
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Preserved Ejection Fraction

Locations

Country	Name	City	State
United Kingdom	Cambridge University Hospital NHS Foundation Trust	Cambridge

Sponsors (4)

Lead Sponsor	Collaborator
Professor Christi Deaton	Keele University, University of Manchester, University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morbidity	Episodes of diseases	1 year from recruitment
Primary	Mortality	Confirmed death during follow-up	1 year from recruitment
Secondary	Kansas City Cardiomyopathy Questionnaire	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.	Baseline, 6 & 12 months
Secondary	6 Minute Walk Test	physical function changes over time	baseline to 6 & 12 months
Secondary	Montreal Cognitive Assessment (MOCA)	cognitive function over time	baseline to 6 & 12 months

External Links

•   Study website