Evaluating heart rate optimization in heart failure patients with CRT-D devices
Dynamic EchoCardiographic Optimisation REsponse Study (Studio Sulla Risposta All'Ottimizzazione Dinamica Ecocardiografica)
This study is testing if adjusting heart rates and delays in heart devices can help people with heart failure feel better when their current treatment isn't working well.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 73 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Academic / other |
| Locations | 1 site (Milano, MI) |
| Trial ID | NCT05473481 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effects of heart rate optimization and guided A-V and V-V delay adjustments using color Doppler echocardiography in patients with heart failure and reduced ejection fraction. It specifically targets individuals who have CRT-D devices but have not responded adequately to the treatment. The study will evaluate clinical and electrophysiological outcomes to determine the effectiveness of these optimizations in improving patient health.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 with heart failure, a left ventricular ejection fraction of less than 45%, and CRT-D devices who are non-responders.
Not a fit: Patients under 18 or over 85 years old, those with insufficient functional capacity, or those with permanent atrial fibrillation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for heart failure patients, enhancing their quality of life and clinical outcomes.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in optimizing heart failure management, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Milano, MI
- IRCCS Ospedale Maggiore Policlinico di Milano — Milano, Mi, Italy (Recruiting)
Study contacts
- Study coordinator: Massimo Saviano, MD
- Email: massimo.saviano@policlinico.mi.it
- Phone: +390255033579
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.