Treating Heart Failure With Enhanced External Counterpulsation (EECP)

Withdrawn

• Conditions: Heart Failure

• Registration Number: NCT03021213
• Lead Sponsor: Charite University, Berlin, Germany

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-27
• Study Start: 2017-01
• Study First Submitted QC: 2017-01-12
• Study First Posted: 2017-01-13
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-17
• Last Update Posted: 2018-04-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Systolic and diastolic heart function	A period of 1 year

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine Berlin; 🇩🇪 Berlin, Germany