Dynamic EchoCardiographic Optimisation REsponse Study

Recruiting

• Conditions: Heart Failure

• Registration Number: NCT05473481
• Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2022-07-19
• Study First Submitted QC: 2022-07-21
• Study First Posted: 2022-07-26
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-11
• Last Update Posted: 2023-09-13
• Primary Completion: 2024-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

1. Patient must be 18 to 85 years of age inclusive, at the time of signing the informed consent form;
2. Heart failure with ventricular ejection fraction left <45%;
3. Presence of CRT-D devices in a non-responder patient for cardiac resynchronization
4. NYHA >II;
5. Resting heart rate <65 beats per minute;
6. Biventricular pacing >97%.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the number of acute heart failure episodes	Baseline to 12 months post discharge	Number of worsening HF episodes requiring hospitalization
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
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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

IRCCS Ospedale Maggiore Policlinico di Milano; 🇮🇹 Milano, MI, Italy