Remote-guided medication up-titration for people with reduced ejection fraction 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 single-center, randomized, open-label trial comparing a telemedicine-based follow-up strategy with standard in-person ambulatory care for patients with newly diagnosed HFrEF. The telemedicine arm uses remote multiparametric monitoring and structured teleconsultations to guide medication up-titration, while the control arm follows conventional clinic visits. The primary outcome is change in a guideline-directed medical therapy (GDMT) score at 6 months; secondary outcomes include safety, treatment adherence, quality of life, and heart failure-related urgent visits, emergency department access, and hospitalizations. Eligible participants are adults not yet on full GDMT who have adequate digital literacy or caregiver support, and the trial is conducted at the Clinical Research Office, AUSL Piacenza (Piacenza, Italy).

Why it matters

Who can join: the full rules

Inclusion criteria: Participants must meet all of the following criteria:

1. Provision of written informed consent.
2. Age ≥18 years.
3. Recent diagnosis of HFrEF, defined according to ESC criteria, established in either an inpatient or outpatient setting.
4. No prior initiation of GDMT for HF at the time of enrollment, or treatment limited to a single agent with potential disease-modifying effects prescribed for a different clinical indication.
5. Availability of adequate digital literacy, either by the patient or a caregiver, defined as the ability to use electronic devices for remote communication (phone/video calls), transmission of vital parameters (body weight, blood pressure, heart rate), and interaction with digital health tools. In cases of insufficient patient digital skills, the presence of a caregiver with adequate digital competence is acceptable.
6. Any etiology of HF is eligible, including ischemic, valvular, primary or infiltrative cardiomyopathies, iatrogenic or toxic causes, and tachycardia-induced cardiomyopathy.

Exclusion Criteria:

* Ongoing treatment with two or more guideline-directed heart failure medications at the time of HFrEF diagnosis
* Presence of severe comorbidities or clinical instability requiring prolonged or continuous hospital management
* Estimated life expectancy \<12 months
* Pregnancy or breastfeeding

Where it's running

• Clinical Research Office, AUSL Piacenza
  Piacenza, Italy Recruiting

Study contacts

• Study coordinator: Clinical Research Office, AUSL Piacenza
• Email: ricerca@ausl.pc.it
• Phone: + 39 0523 302208

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Atrial Shunt to Help Heart Failure With Reduced Ejection Fraction

  This study tests whether an atrial shunt implanted after heart catheterization helps people with HFrEF when added to standard heart failure therapy.

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• Achieving Optimal Medical Therapy Through Transcatheter Mitral Repair in HFrEF

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• CRD-4730 for heart failure with reduced ejection fraction

  This trial tests CRD-4730 versus placebo to see if it helps adults with HFrEF who are already on standard heart failure therapy.

  Recruiting at 2 sites Phase 2 Cardurion Pharmaceuticals, Inc. · Pasadena, California and 1 other locations · NCT07750873

• Olive oil supplementation during cardiac rehab for heart failure with reduced ejection fraction

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• Vericiguat for right‑ventricular function and heart remodeling in HFrEF

  This study will test whether adding vericiguat to usual heart‑failure treatment helps adults with stable HFrEF improve right‑ventricular function and heart remodeling over 12 months.

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• Nerve ablation for heart failure with reduced ejection fraction using the right greater splanchnic nerve

  This early-stage, catheter-based test looks at whether ablating the right greater splanchnic nerve can help people 40 and older with HFrEF and is done in a randomized, sham-controlled setup.

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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.