Dynamic EchoCardiographic Optimisation REsponse Study (DECORE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure

• Study Type: Observational
• Enrollment (Estimated): 73

Contacts and Locations

• Study Contact: Name: Massimo Saviano, MD; Phone Number: +390255033579; Email: massimo.saviano@policlinico.mi.it

Study Locations

• Italy
  • MI
    • Milano, MI, Italy, 20122
      • Recruiting
      • IRCCS Ospedale Maggiore Policlinico di Milano
      • Contact: Massimo Saviano, MD; Phone Number: 0255033579; Email: massimo.saviano@policlinico.mi.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: July 19, 2022
• First Submitted That Met QC Criteria: July 21, 2022
• First Posted (Actual): July 26, 2022

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 2752/6065

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No