Epiphrenic III Pilot Trial

Luzerner Kantonsspital25 enrolled

Overview

The Epiphrenic III Pilot Trial investigates whether a diaphragmatic stimulation by interventionally placed electrodes may improve heart function, symptoms and functional capacity in patients with severe heart failure.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Heart Failure

Interventions

Diaphragmatic stimulationDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Symptomatic heart failure (NYHA functional classes II, III or IV) * Reduced left ventricular ejection fraction (LVEF) \<35% * Guideline-recommended drug therapy Exclusion Criteria: * Patient refuses study participation * Life expectancy presumably \<1 year * Pregnancy

Locations (1)

Luzerner Kantonsspital

Lucerne, Canton of Lucerne, Switzerland

RECRUITING

Outcomes

Primary Outcomes

Left ventricular ejection fraction

Time frame: Four weeks

NYHA functional class

Time frame: Four weeks

Secondary Outcomes

Brain natriuretic peptide (BNP)

Time frame: Four weeks

6-minutes walking test

Time frame: Four weeks

Central Contacts

Paul Erne, MD

CONTACT

++41 41 205 5208 paul.erne@luks.ch

Data from ClinicalTrials.gov

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