Treating Heart Failure With Enhanced External Counterpulsation (EECP)

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03021213
• Other study ID #: EECP
• Status: Withdrawn
• First received: October 27, 2016
• Last updated: April 17, 2018
• Start date: January 2017
• Est. completion date: June 2017

Study information

• Verified date: April 2018
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
Germany	Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic and diastolic heart function		A period of 1 year
Secondary	Ergometric power increase	Ergometric power increase will be measured by individuals' performance in ergometric work load. Scale is Watt.	A period of 1 year
Secondary	Subjective health Status - Mental Health Composite Score	Sf-12-questionnaire: value of the Mental Health Composite Score	A period of 1 year
Secondary	Subjective health Status - Physical Health Composite Score	Sf-12-questionnaire: value of the Physical Health Composite Score	A period of 1 year
Secondary	Organ complications	Relevant laboratory parameters	A period of 1 year