Clinical trial • Phase IV • Cardiology
carvedilol for Takotsubo syndrome|Acute cardiac insufficiency
Phase IV trial of carvedilol for Takotsubo syndrome|Acute cardiac insufficiency. Randomised, open-label. 200 participants.
Overview
- Trial Therapeutic Area
- Cardiology
- Trial Disease
- Takotsubo syndrome|Acute cardiac insufficiency
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 23-02-2024
- First CTIS Authorization Date
- 25-03-2024
Trial design
Randomised, open-label Phase IV trial across 27 sites in Spain.
- Randomised
- Yes
- Open Label
- Yes
- Target Sample Size
- 200
Stratification factors
- site
Eligibility
Recruits 200 No vulnerable populations selected. Written informed consent is required from participants. No assent or parental consent procedures for minors are described..
- Pregnancy Exclusion
- • Pregnant or breastfeeding women.
- Vulnerable Population
- No vulnerable populations selected. Written informed consent is required from participants. No assent or parental consent procedures for minors are described.
Inclusion criteria
- {"criterion_text":"- Written informed consent.\n- Diagnosis of TT (+) with exclusion of significant culprit coronary artery disease by invasive angiography (++)"}
Exclusion criteria
- {"criterion_text":"- Patients diagnosed of TT > 48 hours before.\n- Persistent cardiogenic shock or severe hemodynamic instability\n- Persistent severe (>30 mmHg) intraventricular gradient\n- Previous diagnosis of severe valvular or ventricular disease or prior myocardial infarction secondary to atherosclerotic CAD\n- Patients already receiving treatment with beta-blockers (*)\n- Absolute contraindication/indication for beta-blockers (**)\n- Poor echocardiographic window\n- Pregnant or breastfeeding women.\n- Participation in another clinical trial."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Comparison of left ventricular systolic function recovery as assessed by the echocardiographic left ventricular wall motion score index (WMSI) at 7 days.","definition_or_measurement_approach":"Left ventricular systolic function recovery assessed by the echocardiographic left ventricular wall motion score index (WMSI) at 7 days."}
Secondary endpoints
- {"endpoint_text":"- A) Changes in left ventricular function by other methods (LVEF and GLS).\n- B) Comparison of clinical outcomes (adverse clinical events).","definition_or_measurement_approach":"A) Changes in left ventricular function assessed by LVEF and GLS methods. B) Comparison of clinical outcomes measured as adverse clinical events."}
Recruitment
- Planned Sample Size
- 200
- Recruitment Window Months
- 22
- Consent Approach
- Written informed consent is required. Subject information and informed consent form documents for adults are provided (adult ICF versions listed). No assent or parental consent procedures or languages available are specified.
Geography
- Total Number Of Sites
- 27
- Total Number Of Participants
- 200
Spain
- Earliest CTIS Part Ii Submission Date
- 12-03-2024
- Latest Decision Or Authorization Date
- 28-03-2025
- Processing Time Days
- 381
- Number Of Sites
- 27
- Number Of Participants
- 200
Sites
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Cardiología
- Principal Investigator Name
- Alessandro Sionis
- Principal Investigator Email
- ASIONIS@SANTPAU.CAT
- Contact Person Name
- Alessandro Sionis
- Contact Person Email
- ASIONIS@SANTPAU.CAT
- Site Name
- Hospital Universitario De Torrejon
- Department Name
- Cardiología
- Principal Investigator Name
- Iván Javier Núñez Gil
- Principal Investigator Email
- ibnsky@yahoo.es
- Contact Person Name
- Iván Javier Núñez Gil
- Contact Person Email
- ibnsky@yahoo.es
- Site Name
- University Clinical Hospital Virgen De La Arrixaca
- Department Name
- Cardiología
- Principal Investigator Name
- Francisco Javier Lacunza Ruiz
- Principal Investigator Email
- javierlacunzaruiz@gmail.com
- Contact Person Name
- Francisco Javier Lacunza Ruiz
- Contact Person Email
- javierlacunzaruiz@gmail.com
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Cardiología
- Principal Investigator Name
- Covadonga Fernandez-Golfín loban
- Principal Investigator Email
- covadonga.fernandez-golfin@salud.madrid.org
- Contact Person Name
- Covadonga Fernandez-Golfín loban
- Contact Person Email
- covadonga.fernandez-golfin@salud.madrid.org
- Site Name
- Complexo Hospitalario Universitario A Coruna
- Department Name
- Cardiología
- Principal Investigator Name
- Jose Manuel Vazquez Rodriguez
- Principal Investigator Email
- Jose.Manuel.Vazquez.Rodriguez@sergas
- Contact Person Name
- Jose Manuel Vazquez Rodriguez
- Contact Person Email
- Jose.Manuel.Vazquez.Rodriguez@sergas
- Site Name
- Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
- Department Name
- Cardiología
- Principal Investigator Name
- Emilia Blanco
- Principal Investigator Email
- emiliablancoponce@gmail.com
- Contact Person Name
- Emilia Blanco
- Contact Person Email
- emiliablancoponce@gmail.com
- Site Name
- Hospital Clinico San Carlos
- Department Name
- Cardiología
- Principal Investigator Name
- Hernan David Mejia Renteria
- Principal Investigator Email
- hernandavid.mejia@salud.madrid.org
- Contact Person Name
- Hernan David Mejia Renteria
- Contact Person Email
- hernandavid.mejia@salud.madrid.org
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- Cardiología
- Principal Investigator Name
- Belén Cid
- Principal Investigator Email
- belcid77@hotmail.com
- Contact Person Name
- Belén Cid
- Contact Person Email
- belcid77@hotmail.com
- Site Name
- Hospital Universitario La Paz
- Department Name
- Cardiología
- Principal Investigator Name
- Santiago Jiménez Valero
- Principal Investigator Email
- sjvcardio@yahoo.es
- Contact Person Name
- Santiago Jiménez Valero
- Contact Person Email
- sjvcardio@yahoo.es
- Site Name
- Hospital General Universitario Reina Sofia
- Department Name
- Cardiología
- Principal Investigator Name
- Rafael González Manzanares
- Principal Investigator Email
- rafaelglezm@gmail.com
- Contact Person Name
- Rafael González Manzanares
- Contact Person Email
- rafaelglezm@gmail.com
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- Cardiología
- Principal Investigator Name
- Juan Manuel Escudier
- Principal Investigator Email
- jescudiervilla@yahoo.es
- Contact Person Name
- Juan Manuel Escudier
- Contact Person Email
- jescudiervilla@yahoo.es
- Site Name
- Hospital Universitario De Toledo
- Department Name
- Cardiología
- Principal Investigator Name
- Joaquín Sánchez Prieto Castillo
- Principal Investigator Email
- joaquinsanchezprieto@gmail.com
- Contact Person Name
- Joaquín Sánchez Prieto Castillo
- Contact Person Email
- joaquinsanchezprieto@gmail.com
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Cardiología
- Principal Investigator Name
- Borja Ibañez
- Principal Investigator Email
- bibanez@secardiologia.es
- Contact Person Name
- Borja Ibañez
- Contact Person Email
- bibanez@secardiologia.es
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Cardiología
- Principal Investigator Name
- Tamara García
- Principal Investigator Email
- tamara.garcia@scsalud.es
- Contact Person Name
- Tamara García
- Contact Person Email
- tamara.garcia@scsalud.es
- Site Name
- Hospital Universitario De La Princesa
- Department Name
- Cardiología
- Principal Investigator Name
- Fernando Alfonso
- Principal Investigator Email
- falf@hotmail.com
- Contact Person Name
- Fernando Alfonso
- Contact Person Email
- falf@hotmail.com
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- Cardiología
- Principal Investigator Name
- Xavi Carrillo
- Principal Investigator Email
- xcarrillosuarez@gmail.com
- Contact Person Name
- Xavi Carrillo
- Contact Person Email
- xcarrillosuarez@gmail.com
- Site Name
- Complexo Hospitalario Universitario De Vigo
- Department Name
- Cardiología
- Principal Investigator Name
- Sergio Raposeiras Roubin
- Principal Investigator Email
- raposeiras26@hotmail.com
- Contact Person Name
- Sergio Raposeiras Roubin
- Contact Person Email
- raposeiras26@hotmail.com
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Cardiología
- Principal Investigator Name
- Juan Sanchis
- Principal Investigator Email
- sanchis_juafor@gva.es
- Contact Person Name
- Juan Sanchis
- Contact Person Email
- sanchis_juafor@gva.es
- Site Name
- Hospital Clinico Universitario De Valladolid
- Department Name
- Cardiología
- Principal Investigator Name
- Alberto San Roman Clavar
- Principal Investigator Email
- asanroman@secardiologia.es
- Contact Person Name
- Alberto San Roman Clavar
- Contact Person Email
- asanroman@secardiologia.es
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Cardiología
- Principal Investigator Name
- Manuel Martinez Selles
- Principal Investigator Email
- mmselles@secardiologia.es
- Contact Person Name
- Manuel Martinez Selles
- Contact Person Email
- mmselles@secardiologia.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Cardiología
- Principal Investigator Name
- Irene Buera Surribas
- Principal Investigator Email
- irenebuera@hotmail.com
- Contact Person Name
- Irene Buera Surribas
- Contact Person Email
- irenebuera@hotmail.com
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Cardiología
- Principal Investigator Name
- Manel Sabate
- Principal Investigator Email
- msabate@clinic.cat
- Contact Person Name
- Manel Sabate
- Contact Person Email
- msabate@clinic.cat
- Site Name
- Bellvitge University Hospital
- Department Name
- Cardiología
- Principal Investigator Name
- Ana Lucrecia Marcano
- Principal Investigator Email
- marcanoan@gmail.com
- Contact Person Name
- Ana Lucrecia Marcano
- Contact Person Email
- marcanoan@gmail.com
- Site Name
- Hospital Universitario Central De Asturias
- Department Name
- Cardiología
- Principal Investigator Name
- Paula Antuña Álvarez
- Principal Investigator Email
- paulantu@hotmail.com
- Contact Person Name
- Paula Antuña Álvarez
- Contact Person Email
- paulantu@hotmail.com
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Cardiología
- Principal Investigator Name
- Maite Velázquez Martín
- Principal Investigator Email
- maitevel05@gmail.com
- Contact Person Name
- Maite Velázquez Martín
- Contact Person Email
- maitevel05@gmail.com
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Cardiología
- Principal Investigator Name
- Jorge Sanz Sánchez
- Principal Investigator Email
- sjorge4@gmx.com
- Contact Person Name
- Jorge Sanz Sánchez
- Contact Person Email
- sjorge4@gmx.com
- Site Name
- Hospital Universitario De La Princesa (second site entry)
- Department Name
- Cardiología
- Principal Investigator Name
- Jorge Salamanca
- Principal Investigator Email
- salamanca1982@hotmail.com
- Contact Person Name
- Jorge Salamanca
- Contact Person Email
- salamanca1982@hotmail.com
Sponsor
Primary sponsor
- Full Name
- Fundacion Casa Del Corazon
- Organisation Type
- Educational Institution
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- Beta blocker with alpha activity (ATC C07AG)
- Active Substance
- carvedilol
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Marketed / existing SmPC (used in clinical practice)
- Maximum Dose
- 25 mg
- Investigational Product Name
- Selective beta blocking agents (ATC C07AB)
- Active Substance
- nebivolol|metoprolol|atenolol
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Marketed / existing SmPC (used in clinical practice)
- Maximum Dose
- 5 mg
- Investigational Product Name
- Non-selective beta blocking agents (ATC C07AA)
- Active Substance
- propranolol
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Marketed / existing SmPC (used in clinical practice)
- Maximum Dose
- 40 mg
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