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

N/ANot Yet RecruitingNCT07560982

Università Vita-Salute San Raffaele300 enrolled

Overview

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. Patients will be managed according to routine clinical practice, and no additional treatments are required as part of participation in this study. As this is an observational study, data on the pharmacological therapies taken by the patients according to routine clinical practice will be recorded, without any modification resulting from participation in the present study. The medications are therefore in the patients' possession and are taken orally according to medical prescription, in accordance with the dosages and indications provided in the package leaflet. In particular, GDMT consists of a combination of four classes of medications, which each patient may receive: one renin-angiotensin-aldosterone system drug, one beta-blocker, one mineralcorticoid receptor antagonist and one SGLT2 Inhibitor.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Heart Failure

Interventions

GDMTDRUG

Percentage of patients receiving GDMT in advanced heart failure

Quality of life questionnaireOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (2)

ASST Ospedale Papa Giovanni XXIII

Bergamo, Italy

IRCCS Ospedale San Raffaele

Milan, Italy

Outcomes

Primary Outcomes

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

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

Central Contacts

Anna Maria Scandroglio, MD

CONTACT

0226437154 / +393473249312 scandroglio.mara@hsr.it

Data from ClinicalTrials.gov

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