Heart FailureNCT03021213
Treating Heart Failure With Enhanced External Counterpulsation (EECP)
An observational study of Heart Failure, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Heart Failure
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2017to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with heart failure (NYHA II-IV) * with optimal medical therapy * arisen from ischemic or non-ischemic cardiomyopathy
Who may be able to join
- Patients with heart failure (NYHA II-IV)
- with optimal medical therapy
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine Berlin
Berlin, 13353
About this study
Official title: 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.
- Conditions
- Heart Failure
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic and diastolic heart function
Measured: A period of 1 year
Secondary outcomes (4)
Ergometric power increase
Ergometric power increase will be measured by individuals' performance in ergometric work load. Scale is Watt.
Measured: A period of 1 year
Subjective health Status - Mental Health Composite Score
Sf-12-questionnaire: value of the Mental Health Composite Score
Measured: A period of 1 year
Subjective health Status - Physical Health Composite Score
Sf-12-questionnaire: value of the Physical Health Composite Score
Measured: A period of 1 year
Organ complications
Relevant laboratory parameters
Measured: A period of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study startJan 2017 (estimated)
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia Spies, MD, Prof., Study director, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03021213
- Sponsor's protocol ID
- EECP
- Status last verified
- Apr 2018
- First submitted
- 27 Oct 2016
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Heart Failure With Enhanced External Counterpulsation (EECP): Prospective, Multi-centric Observational Cohort Study
- ClinicalTrials.gov ID
- NCT03021213
- Acronym / sponsor ID
- EECP
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Jan 2017 (estimated)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 13 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with heart failure (NYHA II-IV) * with optimal medical therapy * arisen from ischemic or non-ischemic cardiomyopathy
Key inclusion criteria (6 listed)
- Patients with heart failure (NYHA II-IV)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Systolic and diastolic heart function
Time frame: A period of 1 year
4 secondary outcomes
Ergometric power increase
Time frame: A period of 1 year
Subjective health Status - Mental Health Composite Score
Time frame: A period of 1 year
Subjective health Status - Physical Health Composite Score
Time frame: A period of 1 year
Organ complications
Time frame: A period of 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Spies, MD, Prof. study director
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic and diastolic heart function (time frame: A period of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018; AzTrials last refreshed its copy on 5 Nov 2026.