NCT06509074Not yet recruitingPhase 4
Beta-Blockers in Takotsubo Syndrome Study
Beta-Blockers in Takotsubo Syndrome Study: A Randomized Clinical Trial (β-Tako)
Source: ClinicalTrials.gov · Last updated 26 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The Beta-blockers in Takotsubo syndrome (TTS) (β-Tako) trial, is an academic, pragmatic, prospective, multicenter randomized clinical trial, aiming to assess the efficacy of beta-blockers (BB) in TTS patients. Two-hundred patients with TTS will be randomized (1:1) to BB (n=100) or no BB (n=100). BB with alpha or nitric oxide release activity will be used in the treatment arm. The primary endpoint will be the comparison of the wall motion score index by echocardiography at 7 days. A composite clinical endpoint (death, stroke, admission for recurrent TTS, ACS, heart failure or atrial fibrillation) at 1 year, will be assessed by an independent clinical events committee. Several sub-studies will be performed. The β-Tako trial will inform treatment decisions in this uniquely challenging clinical entity.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 8 Jul 2024
- Start date
- Aug 2024
- Primary completion date
- Dec 2025
- Lead sponsor
- Spanish Society of Cardiology
- Diseases
- Heart failure, Coronary artery disease
- NCT number
- NCT06509074
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 200
- From Aug 2024 to the primary completion date, Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous diagnosis of severe valvular or ventricular disease or prior myocardial infarction secondary to atherosclerotic CAD
- Patients already receiving treatment with betablockers (\*)
Other
- Patients diagnosed of TTS \> 48 hours before.
- Persistent ccardiogenic shock or severe hemodynamic instability
- Persistent severe (\>30 mmHg) intraventricular gradient
- Absolute contraindication/indication for beta-blockers (\*\*)
- Poor echocardiographic window
- Pregnant or breastfeeding women.
- Participation in another clinical trial.
- (\*) Betablockers at a therapeutic dose at the time of symptom´s onset. (\*\*) Close ECG monitoring required in patients with hypotension, bradycardia or cQT interval prolongation
Who the study is looking for
- Written informed consent.
- Diagnosis of TTS with exclusion of significant coronary artery disease (CAD) by invasive coronary angiography
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario de la Princesa Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.