NCT03857022

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

November 22, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 27, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

February 27, 2019

Status Verified

November 1, 2018

Enrollment Period

2 years

First QC Date

November 22, 2018

Last Update Submit

February 25, 2019

Conditions

Heart Failure

Keywords

EECP, Heart Failure, NT-proBNP, Inotropic Agents

Outcome Measures

Primary Outcomes (1)

  • the natriuretic peptide (NT-pro-BNP) level will be reduced.

    the natriuretic peptide (NT-pro-BNP) level will be reduced

    7 week

Secondary Outcomes (2)

  • Weaning from intravenous infusion of positive inotropic agent

    24 week

  • Decrease the length of hospital stay.

    24 week

Study Arms (2)

Enhanced External Counterpulsation

EXPERIMENTAL

Subjects of Heart failure with 'Enhanced External Counterpulsation" therapy

Device: Enhanced External Counterpulsa

No 'Enhanced External Counterpulsation"

NO INTERVENTION

Subjects of Heart failure without 'Enhanced External Counterpulsation" therapy

Interventions

Enhanced External CounterpulsaDEVICE

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) or N-terminal pro-brain natriuretic peptide (NT-pro-BNP) levels will be checked at enrollment, day 35, and 6th month.

Also known as: EECP
Enhanced External Counterpulsation

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patients between 21-80 years of age.
  • Patients who have documented evidence of HF.
  • Evidence of HF required at least one of the following:

You may not qualify if:

  • Patients who had MI or coronary artery bypass grafting (CABG) within three months prior to the initiation of EECP treatment.
  • Patients who had transcatheter intervention (PCI) within 2 weeks prior to the initiation of EECP treatment.
  • Significant valvular heart disease, acute myocarditis.
  • Uncontrolled hypertension (blood pressure 180/100 mmHg).
  • Permanent pacemakers or implantable cardioverter defibrillators.
  • Non bypassed left main coronary with a luminal stenosis greater than 50%.
  • Severe symptomatic peripheral vascular disease.
  • History of deep vein thrombosis.
  • Phlebitis or stasis ulcer.
  • Bleeding diathesis, warfarin use with International Normalized Ratio 2.0.
  • Arial fibrillation or frequent ventricular premature beats that interferes with enhanced external counterpulsation triggering.
  • Baseline ECG abnormalities that would interfere with interpretation of exercise ECG.
  • Pregnant women, or women of childbearing potential but not using adequate birth control.
  • Any medical, psychological, cognitive, social or legal condition that would interfere with the ability of patient to give an Informed Consent and/or his or her capacity to comply with all study requirements, including the necessary time commitment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 10002, Taiwan

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Chii-Ming Lee, PhD

    National Taiwan Unerversity Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chii-Ming Lee, PhD

CONTACT

+886-972-651-087chiiminglee@ntu.edu.tw

Chia-Ling Chang, B.S.N.

CONTACT

+886-975-068-700happytsao@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2018

First Posted

February 27, 2019

Study Start

November 22, 2018

Primary Completion

November 30, 2020

Study Completion

November 30, 2020

Last Updated

February 27, 2019

Record last verified: 2018-11

Locations

TW(1)