MUSCULAR COUNTER PULSATION IN ACUTELY DECOMPENSATED HEART FAILURE

Conditions: heartfailure, muscle counter pulsation, hartfalen,

Registration Number: NL-OMON26361

Lead Sponsor: Maastricht Univarstiait Medisch Centrum, dept of Cardiology

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

a.NYHA class III+ or IV on admission
b.Clinical signs of cardiac decompensation are clearly present at inclusion into the study
c.NT-pro BNP >800 pg/ml
d.Need for intravenous therapy with loop diuretics (e.g. bumetanide) and/or nitro-glycerine

Exclusion Criteria

a.Systolic BP >180mmHg (despite treatment) or < 80mmHg
b.Cardiogenic shock
c.Clinical need for intravenous inotropic medication (excluding digoxin)
d.Need for mechanical therapy (e.g. IABP or invasive ventilation)
e.Prior cardiac transplantation or need for urgent transplantation
f.Acute coronary syndrome within 7 days prior to inclusion
g.Hypertrophic cardiomyopathy, restrictive cardiomyopathy and (sub-) acute myocarditis
h.Severe valvular disease, uncorrected
i.Need for cardiovascular surgical procedure within the following 6 months or within 3 months prior to inclusion
j.Ventricular arrhythmia (repeated with >20% ectopic beats)
k.Atrial fibrillation (HR>100 bmp)
l.Sinus rhythm >120 bpm
m.Bradycardia <60 bpm
n.Deep venous thrombosis
o.Pulmonary emboli
p.Significant systemic infection (e.g. pneumonia)
q.Patient life expectancy of <1 year for non-cardiac reasons
r.Known severe diabetes polyneuropathy
s.Age <18 years

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the effect of MCP on the combination of the cumulative diuretic dosage and length of hospital stay.

Secondary Outcome Measures

Name	Time	Method
a.To evaluate the effect of MCP on muscular function / strength<br>b.To evaluate the effect of MCP on renal function<br>c.To evaluate the effect of MCP on biomarkers known to be important in heart failure<br>d.To evaluate the effect of MCP on the use of positive inotropic substances/ mechanical devices such as e.g. IABP <br>e.To evaluate the effect of MCP on quality of life (36-item Short Form (SF-36)), impact of heart failure on daily living (Kansas City Cardiomyopathy Questionnaire (KCCQ)) <br>f.To evaluate the effect of MCP on length of hospital stay<br>g.To evaluate the feasibility of usage of MCP in everyday acute cardiac care on ICU and peripheral ward <br>h.To evaluate the effect on mortality and re-hospitalisation assessed at 30 days after discharge<br>