Treating Heart Failure With Enhanced External Counterpulsation (EECP)

NCT ID: NCT03021213

Last Updated: 2018-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Claudia Spies

Head of the Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Campus Virchow - Klinikum, Charité - University Medicine Berlin

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Claudia Spies, MD, Prof.

Role: STUDY_DIRECTOR

Charite University, Berlin, Germany

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Berlin, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EECP

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Provocative Tests for HFpEF
NCT06309550 RECRUITING
The Use of Advanced Imaging in HFpEF
NCT06905405 NOT_YET_RECRUITING
Acute Congestive Heart Failure
NCT01885403 UNKNOWN NA