End Stage Heart FailureLVADNCT02174133
Impact of LVAD Implantation on Micro- and Macrovascular Function
An observational study of End Stage Heart Failure, run by Klinik für Kardiologie, Pneumologie und Angiologie at 1 site in Germany.
Trial summary
End stage heart failure is characterized by a critical inability of the heart to meet the organism's blood demand even under resting conditions. Heart transplantation (HTx) is the established therapeutic approach in the treatment of end stage heart failure and still the gold standard treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- End Stage Heart Failure
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2014to Jul 2014
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with end stage heart failure
Who may be able to join
- patients after HTX
- patients after LVAD implantation
- patients with stable coronary heart disease and normal systolic left ventricular function
- healthy volunteers
- written informed consent
Who cannot join
- acute inflammation
- cardiac arrhythmia
- renal failure
- malignant disease
Trial locations and contacts
1 site in 1 country.
Germany1 site
Division of Cardiology, Pulmonology and Vascular Medicine Duesseldorf,
Düsseldorf, 40225
About this study
End stage heart failure is characterized by a critical inability of the heart to meet the organism's blood demand even under resting conditions. Heart transplantation (HTx) is the established therapeutic approach in the treatment of end stage heart failure and still the gold standard treatment. Left ventricular assist devices (LVADs) are considered as a vital therapeutic option to temporarily or permanently assist the failing circulation. The hemodynamic vascular consequences of implanting LVADs have not been studied in detail. The aim of the study is to investigate the effect of LVAD implantation compared to heart transplant (HTx) on micro- and macrovascular function in patients with end stage heart failure.
- Conditions
- End Stage Heart Failure
- Keywords
- left ventricular assist device, endothelial function, microvascular perfusion, microparticles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients after HTX | Not described | |
| patients after LVAD implantation | Not described | |
| patients with coronary heart disease | Not described | |
| healthy volunteers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macrovascular function measured by flow-mediated vasodilation (FMD)
Measured: 3 months after implantation
Secondary outcomes (2)
Microvascular function assessed by non-invasive laser Doppler imaging
Measured: 3 months after implantation
microparticles determined by Flow Cytometry
Measured: 3 months after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study startJan 2014
- Primary completionJun 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Heart FailureStudies of the same condition, open and under way.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klinik für Kardiologie, Pneumologie und Angiologie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
- Investigators
- Christian Heiss, MD, Principal investigator, Division of Cardiology, Pulmonology and Vascular Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02174133
- Sponsor's protocol ID
- LVAD
- Acronym
- LVAD
- Status last verified
- Mar 2015
- First submitted
- 24 Jun 2014
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of LVAD Implantation on Micro- and Macrovascular Function
- ClinicalTrials.gov ID
- NCT02174133
- Acronym / sponsor ID
- LVAD / LVAD
- Conditions
- End Stage Heart Failure
- Keywords
- left ventricular assist device, endothelial function, microvascular perfusion, microparticles
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Klinik für Kardiologie, Pneumologie und AngiologieUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 25 Jun 2014 (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.
End stage heart failure is characterized by a critical inability of the heart to meet the organism's blood demand even under resting conditions. Heart transplantation (HTx) is the established therapeutic approach in the treatment of end stage heart failure and still the gold standard treatment. Left ventricular assist devices (LVADs) are considered as a vital therapeutic option to temporarily or permanently assist the failing circulation. The hemodynamic vascular consequences of implanting LVADs have not been studied in detail. The aim of the study is to investigate the effect of LVAD implantation compared to heart transplant (HTx) on micro- and macrovascular function in patients with end stage heart failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| patients after HTX | – | – |
| patients after LVAD implantation | – | – |
| patients with coronary heart disease | – | – |
| healthy volunteers | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with end stage heart failure
Key inclusion criteria (5 listed)
- patients after HTX
- patients after LVAD implantation
- patients with stable coronary heart disease and normal systolic left ventricular function
- healthy volunteers
- written informed consent
Key exclusion criteria (4 listed)
- acute inflammation
- cardiac arrhythmia
- renal failure
- malignant disease
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
Macrovascular function measured by flow-mediated vasodilation (FMD)
Time frame: 3 months after implantation
2 secondary outcomes
Microvascular function assessed by non-invasive laser Doppler imaging
Time frame: 3 months after implantation
microparticles determined by Flow Cytometry
Time frame: 3 months after implantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2015.
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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.
Christian Heiss, MD principal investigator
Division of Cardiology, Pulmonology and Vascular Medicine
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 End Stage Heart Failure, run by Klinik für Kardiologie, Pneumologie und Angiologie 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 10 Mar 2015. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Macrovascular function measured by flow-mediated vasodilation (FMD) (time frame: 3 months after implantation). 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 10 Mar 2015.