Treating Heart Failure With Enhanced External Counterpulsation (EECP)

Treating Heart Failure With Enhanced External Counterpulsation (EECP): Prospective, Multi-centric Observational Cohort Study

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.

Study Overview

• Status: Withdrawn
• Conditions: Heart Failure

• Study Type: Observational

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with heart failure (NYHA II-IV)

• with optimal medical therapy
• arisen from ischemic or non-ischemic cardiomyopathy

Description

Inclusion Criteria:

• Patients with heart failure (NYHA II-IV)

  1. with optimal medical therapy
  2. 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

Exclusion Criteria:

• 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)
• Accommodation in an institution due to an official or judicial order
• Women: pregnancy or lactation

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Systolic and diastolic heart function	A period of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ergometric power increase	Ergometric power increase will be measured by individuals' performance in ergometric work load. Scale is Watt.	A period of 1 year
Subjective health Status - Mental Health Composite Score	Sf-12-questionnaire: value of the Mental Health Composite Score	A period of 1 year
Subjective health Status - Physical Health Composite Score	Sf-12-questionnaire: value of the Physical Health Composite Score	A period of 1 year
Organ complications	Relevant laboratory parameters	A period of 1 year

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2017
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: October 27, 2016
• First Submitted That Met QC Criteria: January 12, 2017
• First Posted (Estimate): January 13, 2017

Study Record Updates

• Last Update Posted (Actual): April 18, 2018
• Last Update Submitted That Met QC Criteria: April 17, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: EECP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO