Treating Heart Failure With Enhanced External Counterpulsation (EECP)

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03021213

Enrollment

Registered

2017-01-13

Start date

2017-01-31

Completion date

2017-06-30

Last updated

2018-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

Germany

Outcome results