Impedance Measurements in Heart Failure Patients (SIM-HF)

Medtronic

Status and phase: Terminated; Phase 1

Conditions: Heart Failure

Treatments: Device: Akern BIA101 and Custom Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT01509495

RAE00564

Details and patient eligibility

About

The purpose of this study is to measure impedance during inpatient treatment.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients admitted to hospital for symptoms of congestive heart failure
• patients older than 18 years
• patients willing and able to give informed consent

Exclusion criteria

• patients who will require adrenergic or positive inotropic medications
• patients enrolled in a concurrent study that may confound the results of this study
• patients unable or unwilling to participate in study procedures
• patients who are pregnant
• patients who are mentally handicapped or legal incompetent
• patients who are dependent on investigator or sponsor

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)