NCT07851779

Brief Summary

Multicenter, prospective, non-inferiority, randomized, single-blind (primary endpoint evaluators blinded, patients not blinded) clinical trial. We aim to evaluate if the withdrawal of heart failure treatment is safe in patients with non-ischemic cardiomyopathy, negative genetic test, no evidence of late gadolinium enhancement on cardiac MRI, who have been super-responders to cardiac resynchronization therapy and remain free of heart failure events for at least 6 months after device implantation.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for phase_4

Timeline
10mo left

Started Jan 2026

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Jan 2026Jul 2027

Study Start

First participant enrolled

January 14, 2026

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2026

Completed
8 months until next milestone

First Posted

Study publicly available on registry

October 1, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

October 1, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

February 4, 2026

Last Update Submit

September 25, 2026

Conditions

Cardiac Resynchronisation Therapy (CRT)Non-ischemic Cardiomyopathy

Keywords

Heart failure medical treatmentNon-ischemic cardiomyopathyCardiac resynchronization therapyLate gadolinium enhancementCardiogenetic

Outcome Measures

Primary Outcomes (1)

  • Recurrence of left ventricular dysfunction or heart failure symptoms at 6 months

    Any of the following events: * Decrease in LVEF \>10% and final LVEF \<50% * Decrease in LVEF \>10% and increase in LV end-systolic volume \>15% * Appearance of heart failure symptoms accompanied by elevated NT-proBNP requiring initiation of oral, subcutaneous, or intravenous loop diuretic treatment.

    6 months

Secondary Outcomes (9)

  • Emergency room or day hospital visits for heart failure

    6 and 12 months

  • Hospitalizations due to heart failure

    6 and 12 months

  • Ventricular arrhythmias

    6 and 12 months

  • Supraventricular arrhythmias

    6 and 12 months

  • NYHA class

    6 and 12 months

  • +4 more secondary outcomes

Study Arms (2)

Control Group

NO INTERVENTION

Continue heart failure medical tretment without changes

Drugs withdrawal group

ACTIVE COMPARATOR

Heart failure medications are progressively withdrawn, in a máximum period of 9 weeks, always with the same protocol in every patient.

Drug: Withdrawal of Heart failure medications

Interventions

Withdrawal of Heart failure medicationsDRUG

Heart failure drugs will be withdrawn progressively over a maximum of 9 weeks, discontinuing drugs one by one following a predefined sequence

Drugs withdrawal group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of non-ischemic cardiomyopathy
  • LBBB already present at the time of first diagnosis of LV dysfunction
  • Negative genetic test
  • Cardiac MRI with no evidence of late gadolinium enhancement (LGE at RV insertion points is acceptable)
  • Carrier of a resynchronization device (ICD or pacemaker, with LV epicardial pacing form a cardiac vein or left bundle area pacing), pacing percentage \>95% and paced QRS \<140 ms
  • Device indication: LVEF ≤35% and LBBB with QRS \>150 ms
  • LVEF ≥50% and normal indexed LV volumes on echocardiogram performed at least 6 months after CRT implantation
  • No heart failure decompensations (no hospitalizations or urgent/day hospital visits) since CRT implantation
  • No need for loop diuretic treatment
  • NYHA class I or II
  • NT-proBNP \<450 ng/L (or \<1000 ng/L in atrial fibrillation/flutter)
  • On neurohormonal therapy with at least two drugs

You may not qualify if:

  • Family history of non-ischemic cardiomyopathy with LVEF \<50% in at least one first-degree relative
  • Severe valvular heart disease
  • History of sustained ventricular arrhythmia or treated by ICD
  • Need to maintain beta-blocker therapy for other arrhythmias
  • Hypertension not controlled with other medications
  • CRT devices implanted as an upgrade from prior pacemaker or ICD, where prior pacing percentage was \>20%
  • Clinical indication other than heart failure to maintain any of the neurohormonal treatment drugs (class I recommendation in ESC or ACC/AHA guidelines)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

RECRUITING

Hospital Vall d'Hebron

Barcelona, Spain

RECRUITING

Hospital Trueta

Girona, Spain

RECRUITING

Hospital Virgen de las Nieves

Granada, Spain

RECRUITING

Central Study Contacts

Andrea Di Marco, MD, PhD

CONTACT

+34932607686adimarco@bellvitgehospital.cat

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 4, 2026

First Posted

October 1, 2026

Study Start

January 14, 2026

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

October 1, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

ES(4)