Adherence to Guideline-Directed Medical Therapy in Advanced Heart Failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multi-center, observational study that records, without changing care, how patients with advanced heart failure use guideline-directed medical therapy (GDMT) based on a four-pillar approach. Participants receive GDMT and complete a quality-of-life questionnaire as part of routine practice. Data are collected from regular clinical management to see how well current practice aligns with guidelines. No additional treatment is mandated by the study.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age \> 18 and \< 75 years
2. Heart failure with left ventricular ejection fraction ≤ 35%
3. Persistent symptoms of heart failure, New York Heart Association class III or IV
4. Requirement for high-dose diuretic therapy, specifically Furosemide \> 50 mg/day orally as per routine clinical practice
5. At least one of the following additional indicators of severity or refractoriness:
6. need for progressive escalation of diuretics,
7. intolerance to optimized medical therapy,
8. persistence of symptoms despite advanced treatments such as (but not limited to) cardiac resynchronization therapy (CRT-D)and/or MitraClip
9. Ability and willingness to provide written informed consent for participation and for the processing of clinical data for research purposes

Exclusion Criteria:

1. Age ≤ 18 years or ≥ 75 years
2. Left ventricular ejection fraction \> 35%
3. Mild or absent symptoms (New York Heart Association class I-II)
4. Good response to optimized conventional guideline-directed medical therapy
5. Extreme frailty or severe non-reversible disability, or psychiatric or cognitive disorders preventing adherence to follow-up
6. Pregnant or breastfeeding women

Where it's running

• IRCCS Ospedale San Raffaele
  Milan, Italy Recruiting
• ASST Ospedale Papa Giovanni XXIII
  Bergamo, Italy Not yet recruiting

Study contacts

• Principal investigator: Anna Maria Scandroglio, MD — IRCCS Ospedale San Raffaele
• Study coordinator: Anna Maria Scandroglio, MD
• Email: scandroglio.mara@hsr.it
• Phone: 0226437154 / +393473249312

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.