Heart Sheet post marketing product use results survey

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000022534

Enrollment

Registered

2016-05-30

Start date

2016-05-31

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The patient who meets the following all conditions. ?Serious heart failure by a ischemic heart disease. ?NYHA class 3 or 4. ?LVEF &lt

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The patient who meets the following all conditions. ?Serious heart failure by a ischemic heart disease. ?NYHA class 3 or 4. ?LVEF <35% ?Drug therapy with maximal oral medication including digitalis, diuretic, angiotensin-converting enzyme inhibitors, angiotensin 2 receptor blockers, beta-blockers, and diuretics. ?Patients with worsening heart failure after standard treatments (CABG, mitral valvuloplasty, surgical ventricular restoration, CRT, and PCI).

Exclusion criteria

Exclusion criteria: No criteria

Design outcomes

Primary

Measure	Time frame
<Safety>Adverse Event <Efficacy>Evaluation of the survival rate for the life prognosis	—

Secondary

Measure	Time frame
<Efficacy> 1) The absence of hospitalization rate due to any serious cardiovascular events. 2) The ratio of 5% or more improvement about LVEF at 6 months after registration.	—

Countries

Japan

Outcome results