Evaluating Adherence to Guideline-Directed Medical Therapy in Patients With Advanced Heart Failure

ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorUniversità Vita-Salute San Raffaele

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Patients with advanced heart failure, the proportion of patients receiving GDMT will be assessed.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • GDMT

    Drug

    Percentage of patients receiving GDMT in advanced heart failure

  • Quality of life questionnaire

    Other intervention

    Absoute Quality of life questionnaire scores (SF 36 questionnaire and EqVAS scale, both validated in Italian language

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Patients > 18 years and <75 years with advanced heart failure2 interventions

Trial outcomes

Primary outcomes

1

assess the adherence to guideline-directed medical therapy in patients with advanced heart failure

Percentage of patients receiving GDMT in advanced heart failure

Time frame
3 months, 6 months, 1 year, 2 years, 5 years

Secondary outcomes

1

assess the level of quality of life in patients under study

Absoute Quality of life questionnaire scores (short form 36, SF 36, questionnaire and EuroQol Visual Analogue Scale, EqVAS scale, both validated in Italian language). Scored on a 0-100 scale, where higher scores indicate better health.

Time frame
3 months, 6 months, 1 year, 2 years, 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.