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Withdrawal of neurohormonal therapy in patients with non-ischemic cardiomyopathy, no late gadolinium enhancement, and negative genetic testing, who have exhibited super-response to cardiac resynchronization therapy. DRUGLESS-CRT clinical trial.

Status
Not yet recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521780-12-00
Acronym
DRUGLESS-CRT
Enrollment
64
Registered
2025-10-28
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-ischemic cardiomyopathy

Brief summary

Recurrence of left ventricular dysfunction or heart failure at 6 months (any of the following events): Decrease in LVEF >10% and LVEF <50% or; decrease in LVEF >10% and an increase in the left ventricular end-systolic volume >15% or; onset of heart failure symptoms accompanied by an elevation in NT-proBNP requiring initiation of treatment with oral, subcutaneous, or intravenous loop diuretic therapy.

Detailed description

Emergency or day care hospital visits for heart failure at 6 and 12 months, Hospital admissions for heart failure at 6 and 12 months, Ventricular arrhythmias at 6 and 12 months, Supraventricular arrhythmias at 6 and 12 months, NT-proBNP levels at 6 and 12 months, NYHA class at 6 and 12 months, Quality of life at 6 and 12 months, Recurrence of left ventricular dysfunction or heart failure (as defined for the primary endpoint) at 12 months.

Interventions

DRUGATENOLOL
DRUGDAPAGLIFLOZIN
DRUGMETOPROLOL
DRUGEMPAGLIFLOZIN
DRUGNEBIVOLOL
DRUGEPLERENONE
DRUGLOSARTAN
DRUGPROPRANOLOL
DRUGSPIRONOLACTONE
DRUGLISINOPRIL
DRUGENALAPRIL
DRUGRAMIPRIL
DRUGVALSARTAN
DRUGCANDESARTAN
DRUGIRBESARTAN
DRUGBISOPROLOL
DRUGTELMISARTAN
DRUGCAPTOPRIL
DRUGCARVEDILOL

Sponsors

Andrea Di Marco
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Recurrence of left ventricular dysfunction or heart failure at 6 months (any of the following events): Decrease in LVEF >10% and LVEF <50% or; decrease in LVEF >10% and an increase in the left ventricular end-systolic volume >15% or; onset of heart failure symptoms accompanied by an elevation in NT-proBNP requiring initiation of treatment with oral, subcutaneous, or intravenous loop diuretic therapy.

Secondary

MeasureTime frame
Emergency or day care hospital visits for heart failure at 6 and 12 months, Hospital admissions for heart failure at 6 and 12 months, Ventricular arrhythmias at 6 and 12 months, Supraventricular arrhythmias at 6 and 12 months, NT-proBNP levels at 6 and 12 months, NYHA class at 6 and 12 months, Quality of life at 6 and 12 months, Recurrence of left ventricular dysfunction or heart failure (as defined for the primary endpoint) at 12 months.

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026