Evaluating Adherence to Guideline-Directed Medical Therapy in Patients With Advanced Heart Failure
Recruiting · NCT07560982 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
GDMTQuality of life questionnaire
What this trial is about
A Prospective Observational, Multi-Center, Real-World Pharmacological Study Evaluating Adherence to Guideline-Directed Medical Therapy Using the Four-Pillar Strategy in Patients with Advanced Heart Failure
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Age \> 18 and \< 75 years
- Heart failure with left ventricular ejection fraction ≤ 35%
- Persistent symptoms of heart failure, New York Heart Association class III or IV
- Requirement for high-dose diuretic therapy, specifically Furosemide \> 50 mg/day orally as per routine clinical practice
- At least one of the following additional indicators of severity or refractoriness:
- need for progressive escalation of diuretics,
- intolerance to optimized medical therapy,
- persistence of symptoms despite advanced treatments such as (but not limited to) cardiac resynchronization therapy (CRT-D)and/or MitraClip
- Ability and willingness to provide written informed consent for participation and for the processing of clinical data for research purposes
Exclusion criteria
- Age ≤ 18 years or ≥ 75 years
- Left ventricular ejection fraction \> 35%
- Mild or absent symptoms (New York Heart Association class I-II)
- Good response to optimized conventional guideline-directed medical therapy
- Extreme frailty or severe non-reversible disability, or psychiatric or cognitive disorders preventing adherence to follow-up
- Pregnant or breastfeeding women
Where it is running
2 locations listed.
- ASST Ospedale Papa Giovanni XXIII - Bergamo, Italy
- IRCCS Ospedale San Raffaele - Milan, Italy