Chronic Congestive Heart Failure Clinical Trial
| Verified date | July 2016 |
| Source | Hillel Yaffe Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Israel: Ministry of Health |
| Study type | Interventional |
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
| Status | Recruiting |
| Enrollment | 300 |
| Est. completion date | June 2018 |
| Est. primary completion date | June 2018 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Israel | Hillel Yaffe Medical Center | Hadera |
| Lead Sponsor | Collaborator |
|---|---|
| Hillel Yaffe Medical Center |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Reduction of hospitalization for acute heart failure | Five years | No | |
| Secondary | Improved clinical outcome for CHF patients | Five years | No |