Psychosocial Support for Patients With Takotsubo Syndrome

NCT05977049 | Recruiting

• 1 other identifier: 23-04025981
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The study hypothesis is that participants enrolled in a virtual Takotsubo support group will have significantly less anxiety at one year.

Conditions

Takotsubo Cardiomyopathy

Keywords

Takotsubo; Cardiomyopathy; Takotsubo Syndrome

Outcome Measures

Primary Outcomes (1)

• Change in anxiety level as measured by the STAI.

  State Trait Anxiety Inventory (STAI): Score of 20-39 = Low Anxiety; Score of 40-59 = Moderate Anxiety; Score of 60 - 80 = High Anxiety

  Baseline, One year

Secondary Outcomes (2)

• Changes in depression as measured by the PHQ-8.

  Baseline, One year

• Changes in quality of life as measured by the KCCQ.

  Baseline, One year

Study Arms (1)

Takotsubo Support Group

OTHER

Participants diagnosed with Takotsubo Syndrome will be enrolled into the study.

Behavioral: Takotsubo Support Group

Interventions

Takotsubo Support Group BEHAVIORAL

Participants will undergo virtual group therapy/education. Participants will meet once every other week (at minimum), for 1 - 1.5 hours (on average). The frequency and/or length of the support group sessions may be adjusted according to participants' needs.

Takotsubo Support Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- All patients with documented diagnosis of Takotsubo Syndrome greater than 18 years old.

You may not qualify if:

• Patients with a diagnosis of Takotsubo Syndrome already undergoing Psychotherapy or those who choose not to participate.
• Vulnerable populations such as prisoners, non-English speaking subjects, pregnant women, and subjects unable to provide written informed consent will not be included in this research.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10021, United States

RECRUITING

Related Publications (3)

• Sato, H., et al. (1990) Takotsubo-type cardiomyopathy due to multivessel spasm. In: Kodama, K., Haze, K., Hon M, et al., Eds., Clinical Aspect of Myocardial Injury: From Ischemia to Heart Failure, Kagakuhyouronsha, Tpkyo, 56-64.

  BACKGROUND

• Ghadri JR, Wittstein IS, Prasad A, Sharkey S, Dote K, Akashi YJ, Cammann VL, Crea F, Galiuto L, Desmet W, Yoshida T, Manfredini R, Eitel I, Kosuge M, Nef HM, Deshmukh A, Lerman A, Bossone E, Citro R, Ueyama T, Corrado D, Kurisu S, Ruschitzka F, Winchester D, Lyon AR, Omerovic E, Bax JJ, Meimoun P, Tarantini G, Rihal C, Y-Hassan S, Migliore F, Horowitz JD, Shimokawa H, Luscher TF, Templin C. International Expert Consensus Document on Takotsubo Syndrome (Part I): Clinical Characteristics, Diagnostic Criteria, and Pathophysiology. Eur Heart J. 2018 Jun 7;39(22):2032-2046. doi: 10.1093/eurheartj/ehy076.

  PMID: 29850871 BACKGROUND

• Napp LC, Cammann VL, Jaguszewski M, Szawan KA, Wischnewsky M, Gili S, Knorr M, Heiner S, Citro R, Bossone E, D'Ascenzo F, Neuhaus M, Franke J, Sorici-Barb I, Noutsias M, Burgdorf C, Koenig W, Kherad B, Sarcon A, Rajan L, Michels G, Pfister R, Cuneo A, Jacobshagen C, Karakas M, Pott A, Meyer P, Arroja JD, Banning A, Cuculi F, Kobza R, Fischer TA, Vasankari T, Airaksinen KEJ, Hauck C, Paolini C, Bilato C, Imori Y, Kato K, Kobayashi Y, Opolski G, Budnik M, Dworakowski R, MacCarthy P, Kaiser C, Osswald S, Galiuto L, Dichtl W, Chan C, Bridgman P, Beug D, Delmas C, Lairez O, El-Battrawy I, Akin I, Gilyarova E, Shilova A, Gilyarov M, Horowitz JD, Polednikova K, Tousek P, Widimsky P, Winchester DE, Galuszka J, Ukena C, Poglajen G, Carrilho-Ferreira P, Di Mario C, Prasad A, Rihal CS, Schulze PC, Bianco M, Crea F, Borggrefe M, Maier LS, Pinto FJ, Braun-Dullaeus RC, Rottbauer W, Katus HA, Hasenfuss G, Tschope C, Pieske BM, Thiele H, Schunkert H, Bohm M, Felix SB, Munzel T, Bax JJ, Bauersachs J, Braunwald E, Luscher TF, Ruschitzka F, Ghadri JR, Templin C. Coexistence and outcome of coronary artery disease in Takotsubo syndrome. Eur Heart J. 2020 Sep 7;41(34):3255-3268. doi: 10.1093/eurheartj/ehaa210.

  PMID: 32484517 BACKGROUND

MeSH Terms

Conditions

Takotsubo Cardiomyopathy; Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction, Left; Ventricular Dysfunction

Study Officials

• Jim Cheung, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather Glum, BSN, MPA

CONTACT

212-746-4617; hep2011@med.cornell.edu

Dolores Reynolds, BSN

CONTACT

212-746-4617; dtr2001@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All subjects will be placed in a virtual Takotsubo Support Group once enrolled in the study.

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 4, 2023
• Study Start: April 17, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)