Dynamic EchoCardiographic Optimisation REsponse Study

NCT ID: NCT05473481

Last Updated: 2023-09-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 73 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2025-03-31

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.

Conditions

Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

Sponsor Role: lead

Responsible Party

Massimo Saviano

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IRCCS Ospedale Maggiore Policlinico di Milano

Milan, MI, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Massimo Saviano, MD

Role: CONTACT

massimo.saviano@policlinico.mi.it

+390255033579

Facility Contacts

Massimo Saviano, MD

Role: primary

massimo.saviano@policlinico.mi.it

0255033579

Other Identifiers

2752/6065

Identifier Type: -

Identifier Source: org_study_id