MUSCULAR COUNTER PULSATION IN ACUTELY DECOMPENSATED HEART FAILURE

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26361

Enrollment

Registered

2015-01-13

Start date

2015-03-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

heartfailure, muscle counter pulsation, hartfalen,

Interventions

All patients will receive standard HF therapy as applied in all our patients being hospitalized with ADHF. Additionally, patients in the treatment group will be provided with an MCP device (m.pulse, C

Eligibility

Inclusion criteria

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

Exclusion criteria: a. Systolic BP >180mmHg (despite treatment) or 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

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the effect of MCP on the combination of the cumulative diuretic dosage and length of hospital stay.	—

Secondary

Measure	Time frame
a. To evaluate the effect of MCP on muscular function / strength b. To evaluate the effect of MCP on renal function c. To evaluate the effect of MCP on biomarkers known to be important in heart failure d. To evaluate the effect of MCP on the use of positive inotropic substances/ mechanical devices such as e.g. IABP 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)) f. To evaluate the effect of MCP on length of hospital stay g. To evaluate the feasibility of usage of MCP in everyday acute cardiac care on ICU and peripheral ward h. To evaluate the effect on mortality and re-hospitalisation assessed at 30 days after discharge	—

Measure

Time frame

a. To evaluate the effect of MCP on muscular function / strength b. To evaluate the effect of MCP on renal function c. To evaluate the effect of MCP on biomarkers known to be important in heart failure d. To evaluate the effect of MCP on the use of positive inotropic substances/ mechanical devices such as e.g. IABP 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)) f. To evaluate the effect of MCP on length of hospital stay g. To evaluate the feasibility of usage of MCP in everyday acute cardiac care on ICU and peripheral ward h. To evaluate the effect on mortality and re-hospitalisation assessed at 30 days after discharge

—

Contacts

Public ContactC Knacksted

Maastricht Universitair medisch Centrum

043-3877098

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)