BROKEN-SWEDEHEART- Optimized Pharmacological Treatment for Broken Heart (Takotsubo) Syndro
The aim of this study is to document an optimized pharmacologic treatment for patients with Takotsubo Syndrome. There is currently no published documentation in a large number of patients. The study is a Randomized Registry Clinical Trial and in total 1000 patients registered in SWEDEHEART will be included.
| Condition(s) | Takotsubo Syndrome |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| Summary | The aim of this study is to document an optimized pharmacologic treatment for patients with Takotsubo Syndrome. There is currently no published documentation in a large number of patients. The study is a Randomized Registry Clinical Trial and in total 1000 patients registered in SWEDEHEART will be included. |
| Who can participate | Inclusion Criteria: 1. Age ≥ 18 years. 2. A clinical diagnosis of TS (see definition 2.1), including an ejection fraction (EF) ˂ 50 % at baseline 3. Written informed consent obtained Exclusion Criteria: 1. Previous randomization in the trial 2. Any concomitant condition resulting in a life expectancy of less than one month 3. Previously diagnosed left ventricular ejection fraction \<50% 4. Known cardiomyopathy (except previous Takotsubo syndrome) 5. Known hemodynamically significant valve disease (moderate or severe aortic/mitral regurgitation) or stenosis 6. Heart transplant or left ventricular assist device recipient 7. Most recent (within the most recent 3 months) haemoglobin ˂10 g/dL 8. Systolic blood pressure \<80 mm Hg at screening 9. Estimated glomerular filtration rate \<30 mL/min/ |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Vastra Gotaland Region |
| Locations | Aarhus, Denmark; Copenhagen, Denmark; Oslo, Norway; Östersund, Jämtland Härjedalen, Sweden; Jönköping, Region Jönköping, Sweden; Trollhättan, Västra Götalands Region, Sweden (+10 more sites) |
| Start date | 2020-12-14 |
| NCT ID | NCT04666454 |
| Official listing | https://clinicaltrials.gov/study/NCT04666454 |