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

• ClinicalTrials.gov Identifier: NCT03617848
• Recruitment Status: Completed
• First Posted: August 7, 2018
• Last Update Posted: February 15, 2022
• Sponsor: Professor Christi Deaton
• Collaborators: University of Oxford; Keele University; University of Manchester
• Information provided by (Responsible Party): Professor Christi Deaton, Cambridge University Hospitals NHS Foundation Trust

Tracking Information

• First Submitted Date: July 31, 2018
• First Posted Date: August 7, 2018
• Last Update Posted Date: February 15, 2022
• Actual Study Start Date: July 17, 2018
• Actual Primary Completion Date: November 30, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 6, 2018)

• Morbidity [ Time Frame: 1 year from recruitment ]
  Episodes of diseases
• Mortality [ Time Frame: 1 year from recruitment ]
  Confirmed death during follow-up

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 6, 2018)

• 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.
• 6 Minute Walk Test [ Time Frame: baseline to 6 & 12 months ]
  physical function changes over time
• Montreal Cognitive Assessment (MOCA) [ Time Frame: baseline to 6 & 12 months ]
  cognitive function over time

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples Without DNA

Description:

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

• Sampling Method: Non-Probability Sample
• Study Population: Adult males and females with suspected Heart Failure with Preserved Ejection fraction
• Condition: Heart Failure With Preserved Ejection Fraction
• Intervention: Not Provided

Study Groups/Cohorts

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.

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 6, 2020): 153
• Original Estimated Enrollment (submitted: August 6, 2018): 270
• Actual Study Completion Date: March 30, 2021
• Actual Primary Completion Date: November 30, 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 16 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT03617848
• Other Study ID Numbers: 234872
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Professor Christi Deaton, Cambridge University Hospitals NHS Foundation Trust
• Original Responsible Party: Same as current
• Current Study Sponsor: Professor Christi Deaton
• Original Study Sponsor: Same as current

Collaborators

• University of Oxford
• Keele University
• University of Manchester

Investigators

• Principal Investigator: Christi Deaton, PhD,RN; Cambridge University Hospitals NHS FT

• PRS Account: Cambridge University Hospitals NHS Foundation Trust
• Verification Date: February 2022