Dynamic EchoCardiographic Optimisation REsponse Study
DECORE
1 other identifier
observational
73
1 country
1
Brief Summary
The aim of this study is to evaluate the effects of heart rate optimization and guided A-V and V-V delay from color Doppler echocardiography, in subjects affected by heart failure with reduced ejection fraction and CRT-D device wearers who did not respond to device implantation in clinical, electrophysiological, and other terms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2022
Typical duration for all trials
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
July 1, 2022
CompletedFirst Submitted
Initial submission to the registry
July 19, 2022
CompletedFirst Posted
Study publicly available on registry
July 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2025
CompletedSeptember 13, 2023
September 1, 2023
1.8 years
July 19, 2022
September 11, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
Change in the number of acute heart failure episodes
Number of worsening HF episodes requiring hospitalization
Baseline to 12 months post discharge
Change in left ventricular ejection fraction (LVEF)
An echocardiogram will be performed at specific study visits and LEVF will be measured
Baseline to 12 months post discharge
Echocardiofic changes of diastolic left ventricular function
An echocardiogram will be performed at specific study visits and LVESV and LVEDV will be
Baseline to 12 months post discharge
Secondary Outcomes (2)
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ)
Baseline to 12 months post discharge
Change in NYHA class
Baseline to 12 months post discharge
Eligibility Criteria
Subjects affected by heart failure with reduced ejection fraction and CRT-D device wearers, who did not respond to the implantation of the device in clinical and electrophysiological terms.
You may qualify if:
- Patient must be 18 to 85 years of age inclusive, at the time of signing the informed consent form;
- Heart failure with ventricular ejection fraction left \<45%;
- Presence of CRT-D devices in a non-responder patient for cardiac resynchronization
- NYHA \>II;
- Resting heart rate \<65 beats per minute;
- Biventricular pacing \>97%.
You may not qualify if:
- Age \<18 and \>85 years;
- Insufficient functional capacity to complete the tests required by the research protocol;
- Permanent Atrial Fibrillation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IRCCS Ospedale Maggiore Policlinico di Milano
Milan, MI, 20122, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 19, 2022
First Posted
July 26, 2022
Study Start
July 1, 2022
Primary Completion
March 31, 2024
Study Completion
March 31, 2025
Last Updated
September 13, 2023
Record last verified: 2023-09