Clinical trial • Cardiology
LOSARTAN POTASSIUM, HYDROCHLOROTHIAZIDE for Non-ischemic cardiomyopathy
Clinical trial of LOSARTAN POTASSIUM, HYDROCHLOROTHIAZIDE for Non-ischemic cardiomyopathy.
Overview
- Trial Therapeutic Area
- Cardiology
- Trial Disease
- Non-ischemic cardiomyopathy
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 13-05-2025
- First CTIS Authorization Date
- 28-10-2025
Trial design
Maintenance of neurohormonal treatment (continuation/standard care) versus withdrawal of neurohormonal treatment (discontinuation of neurohormonal medications). Specific drug names are the patients' existing neurohormonal medications (e.g., ACE inhibitors, ARBs, beta-blockers, MRAs, SGLT2 inhibitors) as per eligibility; no fixed dose/schedule stated for comparator in registry record.-controlled trial across 6 sites in Spain.
- Comparator
- Maintenance of neurohormonal treatment (continuation/standard care) versus withdrawal of neurohormonal treatment (discontinuation of neurohormonal medications). Specific drug names are the patients' existing neurohormonal medications (e.g., ACE inhibitors, ARBs, beta-blockers, MRAs, SGLT2 inhibitors) as per eligibility; no fixed dose/schedule stated for comparator in registry record.
- Target Sample Size
- 64
- Trial Duration For Participant
- 365
Eligibility
Recruits 64 No vulnerable populations selected; participants are adults (>18 years). Consent is to be provided by the participant; no assent procedures or other vulnerable-population consent arrangements are described..
- Vulnerable Population
- No vulnerable populations selected; participants are adults (>18 years). Consent is to be provided by the participant; no assent procedures or other vulnerable-population consent arrangements are described.
Inclusion criteria
- {"criterion_text":"- Age >18 years"}
- {"criterion_text":"- NYHA Class I or II"}
- {"criterion_text":"- NT-proBNP <450 ng/L (or <1000 ng/L if atrial fibrillation or atrial flutter)"}
- {"criterion_text":"- Neurohormonal treatment with at least two medications"}
- {"criterion_text":"- Diagnosis of non-ischemic cardiomyopathy"}
- {"criterion_text":"- Negative genetic test (at least 50 genes evaluated)"}
- {"criterion_text":"- Cardiac magnetic resonance imaging without evidence of late gadolinium enhancement (RTG is accepted at the insertion points of the right ventricle)."}
- {"criterion_text":"- Carrier of a resynchronization device (ICD or pacemaker, biventricular stimulation or left branch area stimulation) with >95% pacing and stimulated QRS <140ms."}
- {"criterion_text":"- Indication for resynchronization device: LVEF ≤35% and LBBB with QRS >150ms"}
- {"criterion_text":"- LVEF ≥50% and normal indexed left ventricular volumes on echocardiogram performed at least 6 months after the resynchronization device implantation."}
- {"criterion_text":"- No heart failure decompensations (no hospital admissions, no emergency visits, or day care hospital visits) since the implantation of the resynchronization device."}
- {"criterion_text":"- No need for loop diuretic treatment."}
Exclusion criteria
- {"criterion_text":"- Severe valvulopathy"}
- {"criterion_text":"- History of sustained ventricular arrhythmia or treated by ICD"}
- {"criterion_text":"- Need to maintain beta-blocker therapy for other arrhythmias"}
- {"criterion_text":"- Hypertension that cannot be controlled with other medications"}
- {"criterion_text":"- Resynchronization devices implanted as an upgrade from previous pacemaker or ICD, where the pacing percentage before the upgrade was >20%."}
Endpoints
Primary endpoints
- {"endpoint_text":"- 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.","definition_or_measurement_approach":"Composite endpoint measured at 6 months: (1) reduction in left ventricular ejection fraction (LVEF) >10% to an absolute value <50%; (2) reduction in LVEF >10% plus increase in indexed left ventricular end-systolic volume >15%; or (3) new heart failure symptoms with elevated NT-proBNP leading to initiation of loop diuretic therapy (oral, subcutaneous or IV). Assessment via echocardiography for LVEF and LVESV and NT-proBNP laboratory measurement; clinical evaluation for symptoms and initiation of diuretics."}
Secondary endpoints
- {"endpoint_text":"- Emergency or day care hospital visits for heart failure at 6 and 12 months","definition_or_measurement_approach":"Count of emergency department or day-hospital visits for heart failure at 6 and 12 months."}
- {"endpoint_text":"- Hospital admissions for heart failure at 6 and 12 months","definition_or_measurement_approach":"Count of inpatient hospital admissions for heart failure at 6 and 12 months."}
- {"endpoint_text":"- Ventricular arrhythmias at 6 and 12 months","definition_or_measurement_approach":"Occurrence of ventricular arrhythmias documented clinically or by device interrogation at 6 and 12 months."}
- {"endpoint_text":"- Supraventricular arrhythmias at 6 and 12 months","definition_or_measurement_approach":"Occurrence of supraventricular arrhythmias documented clinically or by device interrogation at 6 and 12 months."}
- {"endpoint_text":"- NT-proBNP levels at 6 and 12 months","definition_or_measurement_approach":"Measured NT-proBNP laboratory values at 6 and 12 months."}
- {"endpoint_text":"- NYHA class at 6 and 12 months","definition_or_measurement_approach":"NYHA functional class assessment at 6 and 12 months."}
- {"endpoint_text":"- Quality of life at 6 and 12 months","definition_or_measurement_approach":"Quality-of-life assessment using the trial-specified questionnaire(s) at 6 and 12 months (instrument not specified in registry record)."}
- {"endpoint_text":"- Recurrence of left ventricular dysfunction or heart failure (as defined for the primary endpoint) at 12 months.","definition_or_measurement_approach":"Same composite definition as the primary endpoint, assessed at 12 months."}
Recruitment
- Planned Sample Size
- 64
- Recruitment Window Months
- 18
- Consent Approach
- Informed consent to be obtained from adult participants (>18 years). Subject information and informed consent form document is listed (L1_SIS and ICF general). No details in the registry record on assent, age-specific documents, or languages available.
Geography
- Total Number Of Sites
- 6
- Total Number Of Participants
- 64
Spain
- Earliest CTIS Part Ii Submission Date
- 24-09-2025
- Latest Decision Or Authorization Date
- 05-12-2025
- Processing Time Days
- 72
- Number Of Sites
- 6
- Number Of Participants
- 64
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Cardiology
- Principal Investigator Name
- Jaume Francisco Pascual
- Principal Investigator Email
- jaume.francisco@vallhebron.cat
- Contact Person Name
- Jaume Francisco Pascual
- Contact Person Email
- jaume.francisco@vallhebron.cat
- Site Name
- Hospital Universitari De Girona Doctor Josep Trueta
- Department Name
- Cardiology
- Principal Investigator Name
- Carles Moliner Abos
- Principal Investigator Email
- cmoliner.girona.ics@gencat.cat
- Contact Person Name
- Carles Moliner Abos
- Contact Person Email
- cmoliner.girona.ics@gencat.cat
- Site Name
- Hospital Universitario Virgen De Las Nieves
- Department Name
- Cardiology
- Principal Investigator Name
- Laura Jordán Martínez
- Principal Investigator Email
- laura.jordan.1987@gmail.com
- Contact Person Name
- Laura Jordán Martínez
- Contact Person Email
- laura.jordan.1987@gmail.com
- Site Name
- Bellvitge University Hospital
- Department Name
- Cardiology
- Principal Investigator Name
- Andrea Di Marco
- Principal Investigator Email
- adimarco@bellvitgehospital.cat
- Contact Person Name
- Andrea Di Marco
- Contact Person Email
- adimarco@bellvitgehospital.cat
- Site Name
- Hospital Universitario La Paz
- Department Name
- Cardiology
- Principal Investigator Name
- Inés Ponz de Antonio
- Principal Investigator Email
- ines.ponz@gmail.com
- Contact Person Name
- Inés Ponz de Antonio
- Contact Person Email
- ines.ponz@gmail.com
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Cardiology
- Principal Investigator Name
- Laura Triguero Llonch
- Principal Investigator Email
- LTriguero@santpau.cat
- Contact Person Name
- Laura Triguero Llonch
- Contact Person Email
- LTriguero@santpau.cat
Sponsor
Primary sponsor
- Full Name
- Andrea Di Marco
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Spain
Third parties
- {"country":"Spain","full_name":"Galaxia Empirica S.L.","duties_or_roles":"Sponsor duties code 12 (as listed in registry record); contact email drugless@pinvestiga.com","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Investigational Product Name
- LOSARTAN
- Active Substance
- LOSARTAN POTASSIUM, HYDROCHLOROTHIAZIDE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral
- Authorisation Status
- marketingAuthNumber: '-', prodAuthStatus: 2
- Maximum Dose
- 100 mg/day
- Investigational Product Name
- BISOPROLOL
- Active Substance
- BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral
- Authorisation Status
- marketingAuthNumber: '-', prodAuthStatus: 2
- Maximum Dose
- 10 mg/day
- Investigational Product Name
- VALSARTAN AND SACUBITRIL
- Active Substance
- VALSARTAN, SACUBITRIL
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral
- Authorisation Status
- marketingAuthNumber: '-', prodAuthStatus: 2
- Maximum Dose
- 194 mg/day
- Investigational Product Name
- PROPRANOLOL
- Active Substance
- PROPRANOLOL HYDROCHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Authorisation Status
- marketingAuthNumber: '-', prodAuthStatus: 2
- Maximum Dose
- 160 mg/day
- Investigational Product Name
- EMPAGLIFLOZIN
- Active Substance
- EMPAGLIFLOZIN
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral
- Authorisation Status
- marketingAuthNumber: '-', prodAuthStatus: 2
- Maximum Dose
- 25 mg/day
- Investigational Product Name
- IRBESARTAN
- Active Substance
- VALSARTAN (listed under product entry for IRBESARTAN group)
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral
- Authorisation Status
- marketingAuthNumber: '-', prodAuthStatus: 2
- Maximum Dose
- 300 mg/day
- Investigational Product Name
- LISINOPRIL
- Active Substance
- LISINOPRIL DIHYDRATE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral
- Authorisation Status
- marketingAuthNumber: '-', prodAuthStatus: 2
- Maximum Dose
- 40 mg/day
- Investigational Product Name
- EPLERENONE
- Active Substance
- ALTIZIDE, MICRONISED SPIRONOLACTONE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral
- Authorisation Status
- marketingAuthNumber: '-', prodAuthStatus: 2
- Maximum Dose
- 50 mg/day
- Investigational Product Name
- CAPTOPRIL
- Active Substance
- CAPTOPRIL, HYDROCHLOROTHIAZIDE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral
- Authorisation Status
- marketingAuthNumber: '-', prodAuthStatus: 2
- Maximum Dose
- 150 mg/day
- Investigational Product Name
- CANDESARTAN
- Active Substance
- CANDESARTAN
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral
- Authorisation Status
- marketingAuthNumber: '-', prodAuthStatus: 2
- Maximum Dose
- 32 mg/day
- Investigational Product Name
- CARVEDILOL
- Active Substance
- PERINDOPRIL TERT-BUTYLAMINE (listed under Carvedilol group)
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral
- Authorisation Status
- marketingAuthNumber: '-', prodAuthStatus: 2
- Maximum Dose
- 50 mg/day
- Investigational Product Name
- ENALAPRIL
- Active Substance
- ENALAPRIL MALEATE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral
- Authorisation Status
- marketingAuthNumber: '-', prodAuthStatus: 2
- Maximum Dose
- 40 mg/day
- Investigational Product Name
- RAMIPRIL
- Active Substance
- HYDROCHLOROTHIAZIDE, RAMIPRIL
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral
- Authorisation Status
- marketingAuthNumber: '-', prodAuthStatus: 2
- Maximum Dose
- 10 mg/day
- Investigational Product Name
- VALSARTAN
- Active Substance
- VALSARTAN, HYDROCHLOROTHIAZIDE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral
- Authorisation Status
- marketingAuthNumber: '-', prodAuthStatus: 2
- Maximum Dose
- 320 mg/day
- Investigational Product Name
- METOPROLOL
- Active Substance
- METOPROLOL SUCCINATE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral
- Authorisation Status
- marketingAuthNumber: '-', prodAuthStatus: 2
- Maximum Dose
- 20 mg/day
- Investigational Product Name
- TELMISARTAN
- Active Substance
- HYDROCHLOROTHIAZIDE, TELMISARTAN
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral
- Authorisation Status
- marketingAuthNumber: '-', prodAuthStatus: 2
- Maximum Dose
- 80 mg/day
- Investigational Product Name
- NEBIVOLOL
- Active Substance
- NEBIVOLOL
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral
- Authorisation Status
- marketingAuthNumber: '-', prodAuthStatus: 2
- Maximum Dose
- 10 mg/day
- Investigational Product Name
- SPIRONOLACTONE
- Active Substance
- CINNARIZINE (listed under Spironolactone group)
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral
- Authorisation Status
- marketingAuthNumber: '-', prodAuthStatus: 2
- Maximum Dose
- 50 mg/day
- Investigational Product Name
- DAPAGLIFLOZIN
- Active Substance
- DAPAGLIFLOZIN PROPANEDIOL
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral
- Authorisation Status
- marketingAuthNumber: '-', prodAuthStatus: 2
- Maximum Dose
- 10 mg/day
- Investigational Product Name
- ATENOLOL
- Active Substance
- ATENOLOL, CHLORTALIDONE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral
- Authorisation Status
- marketingAuthNumber: '-', prodAuthStatus: 2
- Maximum Dose
- 100 mg/day
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