Dynamic EchoCardiographic Optimisation REsponse Study

Heart Failure Clinical Trial

— DECORE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05473481
• Other study ID #: 2752/6065
• Status: Recruiting
• Start date: July 1, 2022
• Est. completion date: March 31, 2025

Study information

• Verified date: September 2023
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: Massimo Saviano, MD
• Phone: +390255033579
• Email: massimo.saviano[@]policlinico.mi.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 73
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
Italy	IRCCS Ospedale Maggiore Policlinico di Milano	Milano	MI

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the number of acute heart failure episodes	Number of worsening HF episodes requiring hospitalization	Baseline to 12 months post discharge
Primary	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
Primary	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	Change in Kansas City Cardiomyopathy Questionnaire (KCCQ)	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.	Baseline to 12 months post discharge
Secondary	Change in NYHA class	Measures of New York Heart Association functional class stratified I to IV at baseline and at each scheduled time.	Baseline to 12 months post discharge