Optimized Management of Comorbidity in Heart Failure With Preserved Ejection Fraction in the Elderly (>60 Years)
OPTIMIZE-HFPEF
1 other identifier
interventional
410
1 country
1
Brief Summary
Growing recognition of the importance of co-morbidities in Heart Failure with Preserved Ejection Fraction (HFPEF) has led to the realization that rather than being a distinct disease entity, HFPEF may represent a spectrum of co-morbidities in elderly breathless patients. Accordingly, progress in managing HFPEF in the elderly requires improved understanding of HFPEF pathogenesis with a focus on the impact of co-morbidities. However, the available evidence is insufficient to determine the true prevalence and severity of co-morbidities as well as their impact on both diagnosis and treatment in HFPEF. Therefore there are widespread diagnostic uncertainty without proven therapy! The purpose of this project is twofold:
- 1.The investigators will study how to improve diagnostic accuracy for HFPEF in elderly patients, despite frequent comorbidities and higher age? How useful is it to add exercise testing and contrast echocardiography as well as biomarker as additional diagnostic tools in elderly HFPEF patients?
- 2.The investigators will test the hypothesis that HFPEF in the elderly is dominated by multiple co-morbidities that are a major part of the syndrome itself that contribute to the development of HFPEF. This hypothesis implies that the treatment of co-morbidities will improve prognosis.
- 3.Validate the diagnostic criteria for HFPEF proposed by European Society of Cardiology 2012, and determine the added diagnostic values of exercise testing and contrast echocardiography as well as biomarker for HFPEF in a multi-center study.
- 4.Determine if systematic screening and optimal management of co-morbidities associated with HFPEF improves the outcomes of patients with HFPEF in a randomized study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2014
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 25, 2015
CompletedFirst Posted
Study publicly available on registry
April 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedSeptember 7, 2018
September 1, 2018
4.5 years
February 25, 2015
September 6, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
A composite endpoint about which includes the patient's well-being symptoms (improved or worsened)
A composite endpoint about which includes the patient's well-being symptoms (improved or worsened). The endpoint consists of 4 effect categories composites that are determined on an individual basis at baseline and at 12 months. Each effect category has to meet either all 4 main criteria (1) Lickert scale 5 levels(breathlessness); (2) Lickert scale (tiredness); (3) NT-proBNP change of 30% from baseline; and (4) any events such the occurence of deaths mortality, hospital admission for heart failure or, use of intravenous diuretics during 12 months
Change between baseline and after 2 years
Secondary Outcomes (1)
All cause mortality or hospitalization
Change between baseline and after 2 years
Study Arms (2)
Intervention
EXPERIMENTALscreening and treatment of comorbidities
Control
PLACEBO COMPARATORNo screening of comorbidity
Interventions
Eligibility Criteria
You may qualify if:
- Validated HFPEF
- Age \>60 years
- Chronic Heart Failure with at least one hospitalization or increased use of diuretics due to worsening is required during the last year
- New York Heart Association class II -IV
- Regarded as optimally treated and stable for at least 4 weeks (physician's opinion)
You may not qualify if:
- Currently enrolled in another study
- Significant chronic obstructive pulmonary disease (COPD) with forced expiratory volume within one second (FEV1) \< 30% (European Respiratory Society criteria) in the last 4 weeks before randomization
- Glomerular filtration rate (GFR) \<30 ml/min/1.73m2 (Modification of Diet in Renal Disease \[MDRD\] GFR Equation)
- Significant primary valve disease
- Body mass index (BMI) \>40
- Severe cognitive dysfunction or dementia
- Expected survival of less than one year
- Planned cardiac surgery, Percutaneous Coronary Intervention
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Göteborg Universitylead
- Umeå Universitycollaborator
- Karolinska Institutetcollaborator
- Uppsala Universitycollaborator
- Vastra Gotaland Regioncollaborator
Study Sites (1)
Dept. Medicine
Gothenburg, Vastragotaland, 41345, Sweden
Related Publications (1)
Fu M, Zhou J, Thunstrom E, Almgren T, Grote L, Bollano E, Schaufelberger M, Johansson MC, Petzold M, Swedberg K, Andersson B. Optimizing the Management of Heart Failure With Preserved Ejection Fraction in the Elderly by Targeting Comorbidities (OPTIMIZE-HFPEF). J Card Fail. 2016 Jul;22(7):539-44. doi: 10.1016/j.cardfail.2016.01.011. Epub 2016 Jan 25.
PMID: 26820355BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael X Fu, Professor
Göteborg University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2015
First Posted
April 24, 2015
Study Start
September 1, 2014
Primary Completion
March 1, 2019
Study Completion
July 1, 2019
Last Updated
September 7, 2018
Record last verified: 2018-09