DECORE: Dynamic EchoCardiographic Optimisation REsponse Study

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico (Other)

Overall Status

Recruiting

CT.gov ID

NCT05473481

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure

Study Design

Study Type:

Observational

Anticipated Enrollment :

73 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Dynamic EchoCardiographic Optimisation REsponse Study (Studio Sulla Risposta All'Ottimizzazione Dinamica Ecocardiografica)

Actual Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Mar 31, 2024

Anticipated Study Completion Date :

Mar 31, 2025

Outcome Measures

Primary Outcome Measures

Change in the number of acute heart failure episodes [Baseline to 12 months post discharge]
Number of worsening HF episodes requiring hospitalization
Change in left ventricular ejection fraction (LVEF) [Baseline to 12 months post discharge]
An echocardiogram will be performed at specific study visits and LEVF will be measured
Echocardiofic changes of diastolic left ventricular function [Baseline to 12 months post discharge]
An echocardiogram will be performed at specific study visits and LVESV and LVEDV will be

Secondary Outcome Measures

Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) [Baseline to 12 months post discharge]
This is a disease-specific health status instrument composed of 23 items that quantify the domains of physical limitation, symptoms, self-efficacy, social limitation, and quality of life limitation due to HF. Scores range from 0 to 100. For the KCCQ overall summary score, a small but clinically meaningful change is ≥ 5 points.
Change in NYHA class [Baseline to 12 months post discharge]
Measures of New York Heart Association functional class stratified I to IV at baseline and at each scheduled time.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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%.

Exclusion Criteria:

Age <18 and >85 years;
Insufficient functional capacity to complete the tests required by the research protocol;
Permanent Atrial Fibrillation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS Ospedale Maggiore Policlinico di Milano	Milano	MI	Italy	20122

Sponsors and Collaborators

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Massimo Saviano, Principal Investigator, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

ClinicalTrials.gov Identifier:

NCT05473481

Other Study ID Numbers:

2752/6065

First Posted:

Jul 26, 2022

Last Update Posted:

Jul 26, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Heart Failure

Study Results

No Results Posted as of Jul 26, 2022