A Study to Evaluate the Effects of EECP in Patients With Heart Failure

Not Applicable

• Conditions: Heart Failure
• Interventions: Device: Enhanced External Counterpulsa

• Registration Number: NCT03857022
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

The aims of this proposal are to investigate whether external enhanced counterpulsation (EECP) can facilitate heart failure (HF) patient weaning from intravenous infusion of positive inotropic agent, and thus decrease the length of hospital stay. The major adverse cardiovascular event (MACE) rate, including death and hospitalization for heart failure, will be monitored for 6 months if patients can be released from hospital. Exercise tolerance (6-minute walking distance) and plasma brain natriuretic peptide (BNP) level will be checked at the end of 6th month.

Detailed Description

Chronic heart failure (CHF) patients dependent on intravenous infusion of positive inotropic agents have not only high mortality rate but also high morbidity in the prolonged hospital course. Medications such as angiotensin conversion enzyme inhibitor or angiotensin II receptor blocker may improve the survival of CHF patients. However, their implication is limited by the presence of hypotension secondary to low cardiac output. External enhanced counterpulsation (EECP), which generates the arterial and intracoronary hemodynamics similar to those of the intra-aortic balloon pump, is a recently approved treatment modality for patients with angina and heart failure. It can improve exercise capacity, quality of life and functional status.

Forty patients of (1) impaired left ventricular systolic function (LVEF 40%) and are dependent on intravenous infusion of positive inotropic agents but (2) without significant aortic regurgitation, overt fluid overload, or symptomatic peripheral arterial insufficiency will be included. They will be randomly allocated into EECP or control groups (n=20 for each). The EECP therapy was given as a 1-hour session, once daily, for a total of 35 sessions. The daily urine amount, blood pressure, time for taper off positive inotropic agents, length of hospital stay, and will be monitored daily in the hospital stay. Patients will be followed-up if he or she can be released from hospital and the mortality, readmission for heart failure, and 6-minute walking distance will be checked at the end of 6th month. Plasma natriuretic peptide (BNP) levels will be checked at enrollment, day 35, and 6th month.

Study Timeline

• Status Verified: 2018-11
• Study Start: 2018-11-22
• Study First Submitted: 2018-11-22
• Study First Submitted QC: 2019-02-25
• Last Update Submitted: 2019-02-25
• Study First Posted: 2019-02-27
• Last Update Posted: 2019-02-27
• Primary Completion: 2020-11-30
• Study Completion: 2020-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced External Counterpulsation	Enhanced External Counterpulsa	Subjects of Heart failure with 'Enhanced External Counterpulsation" therapy

Primary Outcome Measures

Name	Time	Method
the natriuretic peptide (NT-pro-BNP) level will be reduced.	7 week	the natriuretic peptide (NT-pro-BNP) level will be reduced

Secondary Outcome Measures

Name	Time	Method
Decrease the length of hospital stay.	24 week	Decrease the length of hospital stay.
Weaning from intravenous infusion of positive inotropic agent	24 week	Weaning from intravenous infusion of positive inotropic agent

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan