Optimising Management of Patients With Heart Failure With Preserved Ejection Fraction in Primary Care (OPTIMISEHFpEF)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03617848|
Recruitment Status : Unknown
Verified January 2020 by Professor Christi Deaton, Cambridge University Hospitals NHS Foundation Trust.
Recruitment status was: Active, not recruiting
First Posted : August 7, 2018
Last Update Posted : January 7, 2020
|Condition or disease|
|Heart Failure With Preserved Ejection Fraction|
|Study Type :||Observational|
|Actual Enrollment :||153 participants|
|Official Title:||Optimising Management of Patients With Heart Failure With Preserved Ejection Fraction in Primary Care|
|Actual Study Start Date :||July 17, 2018|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2021|
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.
- Morbidity [ Time Frame: 1 year from recruitment ]Episodes of diseases
- Mortality [ Time Frame: 1 year from recruitment ]Confirmed death during follow-up
- 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
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03617848
|Cambridge University Hospital NHS Foundation Trust|
|Cambridge, United Kingdom|
|Principal Investigator:||Christi Deaton, PhD,RN||Cambridge University Hospitals NHS FT|