Outpatient Lung Impedance-Guided Preventive Therapy in Patients With Chronic Heart Failure (CHF)

Hillel Yaffe Medical Center

Status and phase: Unknown; Phase 3

Conditions: Chronic Congestive Heart Failure

Treatments: Other: Lung impedence-guided treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01315223

0010-11-HYMC

Details and patient eligibility

About

Patients suffering from Chronic Heart Failure (CHF) are hospitalized for acute heart failure (AHF) several times a year. Currently, we have no method for prediction of future developments of AHF. In our center we have investigated the monitoring of lung impedence as a predictor for future deterioration. It was found that a decrease in lung impedence of more than 15% from normal value predicts AHF development with sensitivity of 98%. In this study we try to prove the hypothesis that preventive treatment according to lung impedence value may prevent future hospitalizations for AHF and improve clinical outcome.

Patients recruited by year:

2011 - 50; 2012 - 25; 2013 - 35; 2014 - 30; 2015 - 50; 2016 - 5

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients suffering from CHF, NYHA II-IV class
• LV lower than 35% to LV lower than 45%

Exclusion criteria

• Patients with additional disease with life-expectancy of less than 2 years

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

300 participants in 2 patient groups

Conventional treatment CHF patients

No Intervention group

Description:

One hundred and fifty patients with CHF will be treated according to current guidelines (conventional treatment).

Lung impedence-guided treatment

Experimental group

Treatment:

Other: Lung impedence-guided treatment