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New study aims to boost heart failure drug adherence

NCT ID NCT07560982

Knowledge-focused Sponsor: Università Vita-Salute San Raffaele Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 07, 2026 · Updated 3 times

Summary

This observational study will track 300 adults with advanced heart failure to see how well they follow a four-medication treatment plan. Researchers will also measure quality of life using standard questionnaires. The goal is to understand real-world adherence and identify areas for improvement.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
beta-blocker, mineralocorticoid receptor antagonist, SGLT2 inhibitor, renin-angiotensin-aldosterone system drug
What this could lead to
If successful, this study could show that a structured approach helps more patients get the right heart failure medications, potentially improving survival and quality of life.
What could go wrong
This is an observational study, not a treatment trial, so it cannot prove cause and effect. Results may not apply to all heart failure patients, and adherence may still be low despite the strategy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Jul 2036

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

advanced heart failure heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart failure

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • ASST Ospedale Papa Giovanni XXIII

    NOT_YET_RECRUITING

    Bergamo, 24127, Italy

  • IRCCS Ospedale San Raffaele

    RECRUITING

    Milan, 20132, Italy

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