Treating Heart Failure With Enhanced External Counterpulsation (EECP)
1 other identifier
observational
N/A
1 country
1
Brief Summary
Enhanced external counterpulsation (EECP) is an outpatient coronary artery disease (CAD) therapy that involves the cyclical inflation/deflation of cuffs wrapped around the lower extremities. However, the possible benefits of EECP in patients with heart failure (HF) (New York Heart Association \[NYHA\] classes II to IV) and cardiomyopathy are unclear.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2017
Shorter than P25 for all trials
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedFirst Posted
Study publicly available on registry
January 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedApril 18, 2018
April 1, 2018
5 months
October 27, 2016
April 17, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Systolic and diastolic heart function
A period of 1 year
Secondary Outcomes (4)
Ergometric power increase
A period of 1 year
Subjective health Status - Mental Health Composite Score
A period of 1 year
Subjective health Status - Physical Health Composite Score
A period of 1 year
Organ complications
A period of 1 year
Eligibility Criteria
Patients with heart failure (NYHA II-IV) * with optimal medical therapy * arisen from ischemic or non-ischemic cardiomyopathy
You may qualify if:
- Patients with heart failure (NYHA II-IV)
- with optimal medical therapy
- caused by ischemic or non-ischemic cardiomyopathy
- EECP-Therapy and Treatment in the Cardio Centrum Berlin or Charité - University Medicine Berlin
- Aged 18 to 100 years
- Offered patient information and written informed consent
You may not qualify if:
- Participation in another interventional trial
- Acute coronary syndrome \< 4 weeks prior to enrollment
- Operation \< 4 weeks prior to enrollment
- Stroke \< 4 weeks prior to enrollment
- Clinically significant disease with hospitalization
- Aortic valvular heart disease ≥ moderate
- Aortic aneurysm
- clinically relevant severe cardiopulmonal diseases
- Resting RR \> 160/90mmHg
- Thrombose, Thrombophlebitis \< 8 weeks prior to enrollment
- Peripheral artery occlusive disease ≥ Stadium II
- Acute Heart failure
- Pathological bleeding tendency
- Arrhythmias, which interfere with Triggering of the EECP
- Other diseases, that inhibit EECP-Treatment (e.g. Spinal disc herniation)
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine Berlin
Berlin, 13353, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Claudia Spies, MD, Prof.
Charite University, Berlin, Germany
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of the Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Campus Virchow - Klinikum, Charité - University Medicine Berlin
Study Record Dates
First Submitted
October 27, 2016
First Posted
January 13, 2017
Study Start
January 1, 2017
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
April 18, 2018
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share