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Clinical Trials/JPRN-jRCTs031230348
JPRN-jRCTs031230348
Recruiting
未知

Exploratory clinical study on efficacy and safety of hochuekkito for exercise capacity of patients with heart failure in home-based cardiac rehabilitation

Amiya Eisuke0 sites30 target enrollmentSeptember 19, 2023

Overview

Phase
未知
Intervention
Not specified
Conditions
Heart failure patients scheduled to undergo home-based cardiac rehabilitation
Sponsor
Amiya Eisuke
Enrollment
30
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 19, 2023
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Amiya Eisuke

Eligibility Criteria

Inclusion Criteria

  • 1\) Patients performing home\-based cardiac rehabilitation
  • 2\) Patients with stage C heart failure staging in ACCF/AHA guidelines
  • 3\) Patients who can walk independently
  • 4\) Patients aged 18 or older
  • 5\) Male or female
  • 6\) Patients who can take study drug orally
  • 7\) Patients who are able to provide written consent

Exclusion Criteria

  • 1\) Patients with biventricular pacemaker placement or after implantation of a ventricular assist device
  • 2\) Patients with a history of heart transplantation
  • 3\) Patients at risk of severe arrhythmia, including ventricular tachycardia
  • 4\) Patients with serum potassium levels less than 3\.0 mEq/L within 12 weeks before enrollment
  • 5\) Patients with severe liver or renal disorder
  • 6\) Patients with malignant tumors
  • 7\) Patients with mental illness who cannot respond to questionnaire surveys
  • 8\) Patients who have a history of allergies or side effects (such as pseudo aldosteronism) in kampo (herbal medicine)
  • 9\) Patients with a history of serious drug allergy such as anaphylactic shock or a history of serious side effects
  • 10\) Patients taking prohibited drugs or study drugs within 2 weeks before consent

Outcomes

Primary Outcomes

Not specified

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