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

Primary Purpose

Heart Failure

Status

Unknown status

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Enhanced External Counterpulsa

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring EECP, Heart Failure, NT-proBNP, Inotropic Agents

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria All answers must be "Yes" for study entry.

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:

LVEF <40%. As assessed with 3 months prior to enrollment, and LVEF can be measured through echocardiogram or radionuclide angiocardiography (RNA); Clinical symptoms of HF, namely the presence of 2 major criteria or 1 major criterion + 2 minor criteria according to the Framingham score; NYHA Fc III or IV ACC/AHA stage D 3. Treated with inotropic agents. Inotropic agents include dopamine, dobutamine, milrinone, norepinephrine. Low dose is included as well. 4. Patients who sign the informed consent . Exclusion criteria All answers must be "No" for study entry.

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.

Sites / Locations

National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Enhanced External Counterpulsation

No 'Enhanced External Counterpulsation"

Arm Description

Subjects of Heart failure with 'Enhanced External Counterpulsation" therapy

Subjects of Heart failure without 'Enhanced External Counterpulsation" therapy

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Weaning from intravenous infusion of positive inotropic agent

Decrease the length of hospital stay.

Full Information

NCT ID

NCT03857022

First Posted

November 22, 2018

Last Updated

February 25, 2019

Sponsor

National Taiwan University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03857022

Brief Title

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

Official Title

An Open-label Study to Evaluate the Effects of Enhanced External Counterpulsation on Tapering Inotropic Agents, Reduction of Brain Natriuretic Peptide and Rehospitalization in Patients With Heart Failure

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Unknown status

Study Start Date

November 22, 2018 (Actual)

Primary Completion Date

November 30, 2020 (Anticipated)

Study Completion Date

November 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

Keywords

EECP, Heart Failure, NT-proBNP, Inotropic Agents

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Enhanced External Counterpulsation

Arm Type

Experimental

Arm Description

Subjects of Heart failure with 'Enhanced External Counterpulsation" therapy

Arm Title

No 'Enhanced External Counterpulsation"

Arm Type

No Intervention

Arm Description

Subjects of Heart failure without 'Enhanced External Counterpulsation" therapy

Intervention Type

Device

Intervention Name(s)

Enhanced External Counterpulsa

Other Intervention Name(s)

EECP

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

7 week

Secondary Outcome Measure Information:

Title

Weaning from intravenous infusion of positive inotropic agent

Description

Weaning from intravenous infusion of positive inotropic agent

Time Frame

24 week

Title

Decrease the length of hospital stay.

Description

Decrease the length of hospital stay.

Time Frame

24 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria All answers must be "Yes" for study entry. 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: LVEF <40%. As assessed with 3 months prior to enrollment, and LVEF can be measured through echocardiogram or radionuclide angiocardiography (RNA); Clinical symptoms of HF, namely the presence of 2 major criteria or 1 major criterion + 2 minor criteria according to the Framingham score; NYHA Fc III or IV ACC/AHA stage D 3. Treated with inotropic agents. Inotropic agents include dopamine, dobutamine, milrinone, norepinephrine. Low dose is included as well. 4. Patients who sign the informed consent . Exclusion criteria All answers must be "No" for study entry. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chii-Ming Lee, PhD

Phone

+886-972-651-087

chiiminglee@ntu.edu.tw

First Name & Middle Initial & Last Name or Official Title & Degree

Chia-Ling Chang, B.S.N.

Phone

+886-975-068-700

happytsao@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chii-Ming Lee, PhD

Organizational Affiliation

National Taiwan Unerversity Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Taiwan University Hospital

City

Taipei

ZIP/Postal Code

10002

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chii-Ming Lee

Phone

0972-651-087

chiiminglee@ntu.edu.tw

12. IPD Sharing Statement

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

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