Non-ischemic CardiomyopathyPhase 4DRUGLESS-CRTNCT07851779
Withdrawal of Heart Failure Treatment Patients With Non-ischemic Cardiomyopathy Who Have Been Super-responders to Cardiac Resynchronization Therapy.
A Phase 4 study testing Withdrawal of Heart failure medications in people with Non-ischemic Cardiomyopathy and Cardiac Resynchronisation Therapy (CRT), run by Institut d'Investigació Biomèdica de Bellvitge at 4 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-ischemic Cardiomyopathy, Cardiac Resynchronisation Therapy (CRT)
- What is being tested?
- Withdrawal of Heart failure medications
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 4 sitesSpain
- Study dates
- 14 Jan 2026to 31 Jul 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain4 sites, 4 recruiting
- Recruiting
Hospital Vall d'Hebron
Barcelona
Jaume Francisco Pascual, +34932607686, adimarco@bellvitgehospital.cat
- Recruiting
Hospital Trueta
Girona
Carles Moliner, +34932607686, adimarco@bellvitgehospital.cat
- Recruiting
Hospital Virgen de las Nieves
Granada
Laura Jordan, +34932607686, adimarco@bellvitgehospital.cat
- Recruiting
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Andrea Di Marco, +34932607686, adimarco@bellvitgehospital.cat
About this study
Official title: Withdrawal of Heart Failure Treatment in Patients With Non-ischemic Cardiomyopathy, Without Late Gadolinium Enhancement and With a Negative Genetic Test, Who Have Been Super-responders to Cardiac Resynchronization Therapy.
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.
- Being tested
- Withdrawal of Heart failure medications
- Keywords
- Heart failure medical treatment, Non-ischemic cardiomyopathy, Cardiac resynchronization therapy, Late gadolinium enhancement, Cardiogenetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Withdrawal of Heart failure medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (9)
Emergency room or day hospital visits for heart failure
Measured: 6 and 12 months
Hospitalizations due to heart failure
Measured: 6 and 12 months
Ventricular arrhythmias
Sustained ventricular tachycardia, sudden cardiac death, appropriate ICD therapy
Measured: 6 and 12 months
Supraventricular arrhythmias
Sustained supraventricular arrhythmia, including sustained atrial fibrillation, sustained atrial flutter and sustained atrial tachycardia
Measured: 6 and 12 months
NYHA class
New York Heart Association functional class, limits I-IV, higher scores means worse outcome
Measured: 6 and 12 months
NtproBNP
levels of NTproBNP, as measured in blood sample
Measured: 6 and 12 months
Quality of life, assessed with KCCQ
KCCQ: Kansas City Cardiomyopathy Questionnaire, minimum and maximum values 0-100, higher scores indicate better outcome
Measured: 6 and 12 months
Quality of life as evaluated with the EQ-5D-5L, EQ VAS
EuroQol five-dimension, five-level questionnaire - visual analogue scale, minimum and maximum value 0-100, higher score indicates better outcome
Measured: 6 months and 12 months
Quality of life evaluated with the EQ-5D-5L-index value
EuroQol five-dimension, five-level questionnaire - index value, minimum and maximum value 0-1, higher score indicates better outcome
Measured: 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start14 Jan 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-ischemic CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut d'Investigació Biomèdica de Bellvitge
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Virgen de las Nieves, Hospital de Sant Pau, Hospital Vall d'Hebron, Hospital Universitario La Paz, Hospital Universitari de Bellvitge
- Responsible party
- Principal investigator, Andrea Di Marco, Institut d'Investigació Biomèdica de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07851779
- Sponsor's protocol ID
- DRUGLESS-CRT
- Other IDs
- 2025-521780-12-00, 2025
- Acronym
- DRUGLESS-CRT
- Status last verified
- Sep 2026
- First submitted
- 4 Feb 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Withdrawal of Heart Failure Treatment in Patients With Non-ischemic Cardiomyopathy, Without Late Gadolinium Enhancement and With a Negative Genetic Test, Who Have Been Super-responders to Cardiac Resynchronization Therapy.
- ClinicalTrials.gov ID
- NCT07851779
- Acronym / sponsor ID
- DRUGLESS-CRT / DRUGLESS-CRT
- Keywords
- Heart failure medical treatment, Non-ischemic cardiomyopathy, Cardiac resynchronization therapy, Late gadolinium enhancement, Cardiogenetic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Institut d'Investigació Biomèdica de BellvitgeUniversity, hospital or other
- Collaborators
- University Hospital Virgen de las Nieves, Hospital de Sant Pau, Hospital Vall d'Hebron, Hospital Universitario La Paz, Hospital Universitari de Bellvitge
- Study start
- 14 Jan 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 1 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Continue heart failure medical tretment without changes |
| Drugs withdrawal group | Active comparator | Drug: Withdrawal of Heart failure medicationsHeart failure medications are progressively withdrawn, in a máximum period of 9 weeks, always with the same protocol in every patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Withdrawal of Heart failure medicationsHeart failure drugs will be withdrawn progressively over a maximum of 9 weeks, discontinuing drugs one by one following a predefined sequence | Drug | Drugs withdrawal group |
Primary outcome
Recurrence of left ventricular dysfunction or heart failure symptoms at 6 months
Time frame: 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.
9 secondary outcomes
Emergency room or day hospital visits for heart failure
Time frame: 6 and 12 months
Hospitalizations due to heart failure
Time frame: 6 and 12 months
Ventricular arrhythmias
Time frame: 6 and 12 months
Supraventricular arrhythmias
Time frame: 6 and 12 months
NYHA class
Time frame: 6 and 12 months
NtproBNP
Time frame: 6 and 12 months
Quality of life, assessed with KCCQ
Time frame: 6 and 12 months
Quality of life as evaluated with the EQ-5D-5L, EQ VAS
Time frame: 6 months and 12 months
Quality of life evaluated with the EQ-5D-5L-index value
Time frame: 6 months and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Withdrawal of Heart failure medications in people with Non-ischemic Cardiomyopathy and Cardiac Resynchronisation Therapy (CRT), run by Institut d'Investigació Biomèdica de Bellvitge at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Di Marco, MD, PhD (+34932607686, adimarco@bellvitgehospital.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of left ventricular dysfunction or heart failure symptoms at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.