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NCT04325321: BHS
The Broken Heart Study II (BHS-II)
NA trial testing Stress reactivity test in Takotsubo Cardiomyopathy in 66 participants. Completed in 28 February 2026.
11 November 2025
Quick facts
| Lead sponsor | The Miriam Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 66 |
| Start date | 2 September 2020 |
| Primary completion | 11 November 2025 |
| Estimated completion | 28 February 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Stress reactivity test
Conditions studied
- Takotsubo Cardiomyopathy — all drugs for Takotsubo Cardiomyopathy →
Sponsor
The Miriam Hospital
Who can join
18 and older, any sex, with Takotsubo Cardiomyopathy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goals of this study are as follows: 1. To rigorously establish and characterize heterogeneity in the pathophysiology of Takotsubo Syndrome (TS). 2. To rigorously test the contribution of TS triggering events and mental stress responsiveness to 1-year prognosis after TS event.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Psychological factors and blood pressure responses to acute stress in women with takotsubo syndrome: an exploratory study.
Ouaddi S, Keirns NG, Lee SY, Dunsiger S, et al · · 2025 · cited 2× · PMID 39422192 · DOI 10.1093/eurjcn/zvae148 -
"Eventually…Your Body Just Can't No More": An Exploration of Patient Perspectives on Events Preceding Takotsubo Syndrome Episodes.
Keirns NG, Rosen RK, Burg M, Gathright E, et al · · 2025 · cited 1× · PMID 39913262 · DOI 10.1097/jcn.0000000000001106 -
Chronic adrenocortical activity and onset of Takotsubo syndrome.
Salmoirago-Blotcher E, Keirns NG, Ouaddi S, Tripolone J, et al · · 2026 · PMID 41562264 · DOI 10.1093/eurjcn/zvag023 -
Takotsubo Syndrome in 2025: Evolving Concepts in Pathophysiology, Diagnosis, and Long-Term Management.
McKenzie A, Bargout R. · · 2025 · PMID 41517446 · DOI 10.3390/jcm15010197
Verify or expand the search:
- PubMed search for NCT04325321
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Takotsubo Cardiomyopathy
Currently open trials in the same condition.
- NCT07491718 — Manganese-enhanced Magnetic Resonance Imaging in Takotsubo Cardiomyopathy · NA · recruiting
- NCT06597331 — Cardiac Assessment and Takotsubo-stunning Among COPD-exacerbations In-Hospital · recruiting
- NCT05977049 — Psychosocial Support for Patients With Takotsubo Syndrome · NA · recruiting
- NCT06332859 — Effectiveness of a Resilience-Based Rehabilitation Program for Patients with Coronary Heart Disease · NA · recruiting
- NCT05793008 — Characterization of priMary And sEcondary STress Related takOtsubo · NA · recruiting
Other The Miriam Hospital trials
Trials by the same sponsor.
- NCT07228130 — Microrandomized Trial to Optimize Use of Burden-reducing Self-monitoring Approaches in Behavioral Obesity Treatment · NA · recruiting
- NCT07363616 — Pilot Test of Five Weight Neutral Interventions to Improve Health Among Adults of Higher Body Weight · NA · recruiting
- NCT06494488 — Differential Thrombogenesis by EPA and DHA Mediated by HDL · EARLY_PHASE1 · recruiting
- NCT06878872 — Type 1 Diabetes Adolescents for Healthier Lifestyles Study · NA · not yet recruiting
- NCT06875622 — Remote Approaches for Optimizing Weight Loss (Elevate Weight Loss Trial) · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04325321 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The Miriam Hospital
- Last refreshed: 13 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04325321.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing