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New treatment option for Non-ischemic Dilated Cardiomyopathy
Official title Study of Personalized Allocation of Defibrillators in Non-ischemic Heart Failure (SPANISH-1)
ClinicalTrials.gov ID: NCT06055504
What this study is testing
- What it's testing
- Prospective, randomised, multicentre, open-label study to assess the non-inferiority of a personalised precision strategy for Sudden Cardiac Death (SCD) prevention in patients with non-ischemic dilated cardiomyopathy with Left Ventricular Ejection Fraction (LVEF) ≤35%
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years at the time of screening.
- Previously established diagnosis of Non-ischemic DCM
- Optimised medical treatment at maximum tolerated doses for at least 3 months prior to the screening date.
- NYHA functional class II-III.
- LVEF ≤ 35% documented by CMR as study procedure.
You likely can't join if
- History of coronary artery disease justifying the presence of ventricular dysfunction, defined as: history of coronary revascularisation or presence...
- Left ventricular dysfunction attributed to congenital heart disease, valvular disease, alcohol abuse or chemotherapy.
- Hypertrophic or infiltrative cardiomyopathy, active myocarditis or constrictive pericarditis.
- History of recovered sudden death or sustained ventricular tachycardia.
- NYHA functional class IV.
- Waiting list for cardiac transplantation in emergency 0.
See the full eligibility criteria
- Age ≥ 18 years at the time of screening.
- Previously established diagnosis of Non-ischemic DCM
- Optimised medical treatment at maximum tolerated doses for at least 3 months prior to the screening date.
- NYHA functional class II-III.
- LVEF ≤ 35% documented by CMR as study procedure.
- Life expectancy greater than 12 months.
- History of coronary artery disease justifying the presence of ventricular dysfunction, defined as: history of coronary revascularisation or presence of significant coronary stenosis (≥50% in left main or ≥70% in a major...
- Left ventricular dysfunction attributed to congenital heart disease, valvular disease, alcohol abuse or chemotherapy.
- Hypertrophic or infiltrative cardiomyopathy, active myocarditis or constrictive pericarditis.
- History of recovered sudden death or sustained ventricular tachycardia.
- NYHA functional class IV.
- Waiting list for cardiac transplantation in emergency 0.
- Receiver of a solid organ transplant (lung, liver, heart or kidney).
The study team makes the final eligibility decision.
Where it's taking place
- Santiago de Compostela, A Coruña, Spain
- L'Hospitalet de Llobregat, Barcelona, Spain
- Sabadell, Barcelona, Spain
- A Coruña, La Coruña, Spain
- Majadahonda, Madrid, Spain
- Oviedo, Principality of Asturias, Spain
- Alicante, Spain
- Barcelona, Spain
- Girona, Spain
- Granada, Spain
- Lleida, Spain
- Madrid, Spain
- Málaga, Spain
- Murcia, Spain
- Palma de Mallorca, Spain
- Pamplona, Spain
- Salamanca, Spain
- Seville, Spain
- Toledo, Spain
- Valencia, Spain
+ 2 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Santiago de Compostela, A Coruña, Spain; L'Hospitalet de Llobregat, Barcelona, Spain; Sabadell, Barcelona, Spain; A Coruña, La Coruña, Spain; Majadahonda, Madrid, Spain; Oviedo, Principality of Asturias, Spain and 16 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.