Withdrawal of Heart Failure Treatment Patients With Non-ischemic Cardiomyopathy Who Have Been Super-responders to Cardiac Resynchronization Therapy. (DRUGLESS-CRT)
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.
Studieöversikt
Status
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 4
Kontakter och platser
Studiekontakt
- Namn: Andrea Di Marco, MD, PhD
- Telefonnummer: +34932607686
- E-post: adimarco@bellvitgehospital.cat
Studieorter
-
-
-
Barcelona, Spanien
- Rekrytering
- Hospital Vall d'Hebron
-
Kontakt:
- Jaume Francisco Pascual
- Telefonnummer: +34932607686
- E-post: adimarco@bellvitgehospital.cat
-
Girona, Spanien
- Rekrytering
- Hospital Trueta
-
Kontakt:
- Carles Moliner
- Telefonnummer: +34932607686
- E-post: adimarco@bellvitgehospital.cat
-
Granada, Spanien
- Rekrytering
- Hospital Virgen de las Nieves
-
Kontakt:
- Laura Jordan
- Telefonnummer: +34932607686
- E-post: adimarco@bellvitgehospital.cat
-
-
Barcelona
-
L'Hospitalet de Llobregat, Barcelona, Spanien, 08907
- Rekrytering
- Hospital Universitari de Bellvitge
-
Kontakt:
- Andrea Di Marco
- Telefonnummer: +34932607686
- E-post: adimarco@bellvitgehospital.cat
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: Control Group
Continue heart failure medical tretment without changes |
|
|
Aktiv komparator: Drugs withdrawal group
Heart failure medications are progressively withdrawn, in a máximum period of 9 weeks, always with the same protocol in every patient. |
Heart failure drugs will be withdrawn progressively over a maximum of 9 weeks, discontinuing drugs one by one following a predefined sequence |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Recurrence of left ventricular dysfunction or heart failure symptoms at 6 months
Tidsram: 6 months
|
Any of the following events:
|
6 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Emergency room or day hospital visits for heart failure
Tidsram: 6 and 12 months
|
6 and 12 months
|
|
|
Hospitalizations due to heart failure
Tidsram: 6 and 12 months
|
6 and 12 months
|
|
|
Ventricular arrhythmias
Tidsram: 6 and 12 months
|
Sustained ventricular tachycardia, sudden cardiac death, appropriate ICD therapy |
6 and 12 months
|
|
Supraventricular arrhythmias
Tidsram: 6 and 12 months
|
Sustained supraventricular arrhythmia, including sustained atrial fibrillation, sustained atrial flutter and sustained atrial tachycardia |
6 and 12 months
|
|
NYHA class
Tidsram: 6 and 12 months
|
New York Heart Association functional class, limits I-IV, higher scores means worse outcome |
6 and 12 months
|
|
NtproBNP
Tidsram: 6 and 12 months
|
levels of NTproBNP, as measured in blood sample |
6 and 12 months
|
|
Quality of life, assessed with KCCQ
Tidsram: 6 and 12 months
|
KCCQ: Kansas City Cardiomyopathy Questionnaire, minimum and maximum values 0-100, higher scores indicate better outcome |
6 and 12 months
|
|
Quality of life as evaluated with the EQ-5D-5L, EQ VAS
Tidsram: 6 months and 12 months
|
EuroQol five-dimension, five-level questionnaire - visual analogue scale, minimum and maximum value 0-100, higher score indicates better outcome |
6 months and 12 months
|
|
Quality of life evaluated with the EQ-5D-5L-index value
Tidsram: 6 months and 12 months
|
EuroQol five-dimension, five-level questionnaire - index value, minimum and maximum value 0-1, higher score indicates better outcome |
6 months and 12 months
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- DRUGLESS-CRT
- 2025 (U.S.S. NIH-anslag/kontrakt)
- 2025-521780-12-00 (Ctis)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
produkt tillverkad i och exporterad från U.S.A.
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .