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Non-Invasive Lung IMPEDANCE-Guided Preemptive Treatment in Chronic Heart Failure Patients: A Randomized Controlled Trial (IMPEDANCE-HF Trial)
- Source :
- Journal of cardiac failure. 22(9)
- Publication Year :
- 2015
-
Abstract
- Previous investigations have suggested that lung impedance (LI)-guided treatment reduces hospitalizations for acute heart failure (AHF). A single-blind 2-center trial was performed to evaluate this hypothesis (ClinicalTrials.gov-NCT01315223).The study population included 256 patients from 2 medical centers with chronic heart failure and left ventricular ejection fraction ≤35% in New York Heart Association class II-IV, who were admitted for AHF within 12 months before recruitment. Patients were randomized to a control group treated by clinical assessment and a monitored group whose therapy was also assisted by LI, and followed for at least 12 months. Noninvasive LI measurements were performed with a new high-sensitivity device. Patients, blinded to their assignment group, were scheduled for monthly visits in the outpatient clinics. The primary efficacy endpoint was AHF hospitalizations; the secondary endpoints were all-cause hospitalizations and mortality.There were 67 vs 158 AHF hospitalizations during the first year (P .001) and 211 vs 386 AHF hospitalizations (P .001) during the entire follow-up among the monitored patients (48 ± 32 months) and control patients (39 ± 26 months, P = .01), respectively. During the follow-up, there were 42 and 59 deaths (hazard ratio 0.52, 95% confidence interval 0.35-0.78, P = .002) with 13 and 31 of them resulting from heart failure (hazard ratio 0.30, 95% confidence interval 0.15-0.58 P .001) in the monitored and control groups, respectively. The incidence of noncardiovascular death was similar.Our results seem to validate the concept that LI-guided preemptive treatment of chronic heart failure patients reduces hospitalizations for AHF as well as the incidence of heart failure, cardiovascular, and all-cause mortality.
- Subjects :
- Male
medicine.medical_specialty
New York Heart Association Class
Pulmonary Edema
030204 cardiovascular system & hematology
High-Density Lipoproteins, Pre-beta
law.invention
03 medical and health sciences
0302 clinical medicine
Randomized controlled trial
law
Reference Values
Internal medicine
Confidence Intervals
Electric Impedance
Medicine
Outpatient clinic
Humans
Single-Blind Method
030212 general & internal medicine
Diuretics
Survival analysis
Aged
Heart Failure
Ejection fraction
business.industry
Stroke Volume
Stroke volume
Middle Aged
medicine.disease
Prognosis
Survival Analysis
Confidence interval
Respiratory Function Tests
Hospitalization
Treatment Outcome
Heart failure
Chronic Disease
Cardiology
Female
Cardiology and Cardiovascular Medicine
business
Subjects
Details
- ISSN :
- 15328414
- Volume :
- 22
- Issue :
- 9
- Database :
- OpenAIRE
- Journal :
- Journal of cardiac failure
- Accession number :
- edsair.doi.dedup.....8ddc4b9217754f2fae982e88e84ce356