Diastolic Heart FailureNCT00718939
Rheos® Diastolic Heart Failure Trial
A study testing Rheos Baroreflex Activation Therapy System in people with Diastolic Heart Failure, run by CVRx, Inc. at 4 sites in Germany.
Trial summary
The CVRx® Rheos® Diastolic Heart Failure Trial is a prospective, randomized, double blind trial with up to 60 subjects conducted at up to five centers in Europe. All subjects will be followed up to one year post implant. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Diastolic Heart Failure
- What is being tested?
- Rheos Baroreflex Activation Therapy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 4 sitesGermany
- Study dates
- Jul 2008to Jul 2012
- Phase
- Interventional
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be at least 21 years of age.
- Have bilateral carotid bifurcations that are below the level of the mandible.
- Have a left ventricular ejection fraction ≥ 45%.
- Clinical Heart Failure with elevated BNP or NT-Pro-BNP.
Who cannot join
- History of or suspected baroreflex failure or autonomic neuropathy.
- History of symptomatic bradyarrhythmias, pericardial constriction, infiltrative cardiomyopathy, cardiac valvular disease.
- Organ or hematologic transplant.
- History of prior surgery, radiation, or stent placement in carotid sinus region.
- History of severe chronic kidney disease.
- Life expectancy to less than one year.
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Kerckhoff-Klinik Forschungsgesellschaft mbH
Bad Nauheim, 61231
University of Cologne
Cologne, 50924
Krankenhaus Reinbek St.Adolfsstif
Hamburg-Reinbek, 21465
Medizinische Hoschschule Hannover
Hanover
About this study
The CVRx® Rheos® Diastolic Heart Failure Trial is a prospective, randomized, double blind trial with up to 60 subjects conducted at up to five centers in Europe. All subjects will be followed up to one year post implant.
- Conditions
- Diastolic Heart Failure
- Being tested
- Rheos Baroreflex Activation Therapy System
- Keywords
- Diastolic Heart Failure, Cardiac dysfunction, Heart Failure
- Medical subject headings
- Heart Failure, Diastolic, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rheos Baroreflex Activation Therapy SystemDevice
The two (2) Rheos Carotid Sinus Leads conduct the activation energy from the Rheos Implantable Pulse Generator to the baroreceptors located on the left (Left Carotid Sinus Lead) and right (Right Carotid Sinus Lead) carotid sinus. This energy activates the baroreflex by inducing signals that the brain interprets as elevated blood pressure.
| Study group | Role | What they receive |
|---|---|---|
| Rheos ON | Other | Study participants in this arm will have the device turn on for six months and remains on. Receives: Device: Rheos Baroreflex Activation Therapy System |
| Rheos OFF | Other | Study participants in this arm will have the device turned off for 6 months and then turned on. Receives: Device: Rheos Baroreflex Activation Therapy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess left ventricular mass index (LVMI).
Measured: at six months post- randomization.
Assess safety by evaluating all adverse events.
Measured: through six months post -implant
Secondary outcomes (1)
To assess difference between randomization groups in blood pressure changes, blood levels and quality of life.
Measured: six months post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diastolic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- CVRx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maximilian A Pichlmaier, MD, Principal investigator, Medizinische Hoschschule HannoverJohannes Sperzel, MD, Principal investigator, Kerckhoff-Klinik Forschungsgesellschaft mbHProf. Uta Hoppe, MD, Principal investigator, University of CologneHerbert Naegele, MD, Principal investigator, Krankenhaus Reinbek St.Adolfsstif
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00718939
- Sponsor's protocol ID
- 360014
- Status last verified
- Oct 2016
- First submitted
- 17 Jul 2008
- Last updated
- 21 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rheos® Diastolic Heart Failure Trial
- ClinicalTrials.gov ID
- NCT00718939
- Acronym / sponsor ID
- 360014
- Conditions
- Diastolic Heart Failure
- Keywords
- Diastolic Heart Failure, Cardiac dysfunction, Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- CVRx, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 21 Jul 2008 (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.
The CVRx® Rheos® Diastolic Heart Failure Trial is a prospective, randomized, double blind trial with up to 60 subjects conducted at up to five centers in Europe. All subjects will be followed up to one year post implant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rheos ON | Other | Device: Rheos Baroreflex Activation Therapy SystemStudy participants in this arm will have the device turn on for six months and remains on. |
| Rheos OFF | Other | Device: Rheos Baroreflex Activation Therapy SystemStudy participants in this arm will have the device turned off for 6 months and then turned on. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be at least 21 years of age.
- Have bilateral carotid bifurcations that are below the level of the mandible.
- Have a left ventricular ejection fraction ≥ 45%.
- Clinical Heart Failure with elevated BNP or NT-Pro-BNP.
Key exclusion criteria (6 listed)
- History of or suspected baroreflex failure or autonomic neuropathy.
- History of symptomatic bradyarrhythmias, pericardial constriction, infiltrative cardiomyopathy, cardiac valvular disease.
- Organ or hematologic transplant.
- History of prior surgery, radiation, or stent placement in carotid sinus region.
- History of severe chronic kidney disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rheos Baroreflex Activation Therapy SystemThe two (2) Rheos Carotid Sinus Leads conduct the activation energy from the Rheos Implantable Pulse Generator to the baroreceptors located on the left (Left Carotid Sinus Lead) and right (Right Carotid Sinus Lead) carotid sinus. This energy activates the baroreflex by inducing signals that the brain interprets as elevated blood pressure. | Device | Rheos OFF, Rheos ON |
Primary outcome
Assess left ventricular mass index (LVMI).
Time frame: at six months post- randomization.
Assess safety by evaluating all adverse events.
Time frame: through six months post -implant
1 secondary outcome
To assess difference between randomization groups in blood pressure changes, blood levels and quality of life.
Time frame: six months post-implant
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 21 Oct 2016.
- Related InfoLink provided by the sponsor.
Related trials for Diastolic Heart Failure
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PrEcision Pacing in HFpEF: the PEP-HFpEF Trial
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Assessment of CCM in HF With Higher Ejection Fraction
Heart Failure, Heart Failure With Preserved Ejection Fraction
Not yet recruiting
Exercise, Mediterranean Diet and Inflammation in Heart Failure
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Recruiting
Optimised Cardiovascular and Renal Protection in Patients With Chronic Kidney Disease and Cardiovascular Disease
Chronic Kidney Disease, Heart Failure With Preserved Ejection Fraction (HFPEF)
RecruitingObservational study
Common Femoral Vein-to-Artery Diameter Ratio for Detection of Elevated LVEDP
Acute Coronary Syndrome, Chronic Coronary Syndrome
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.
Maximilian A Pichlmaier, MD principal investigator
Medizinische Hoschschule Hannover
Johannes Sperzel, MD principal investigator
Kerckhoff-Klinik Forschungsgesellschaft mbH
Prof. Uta Hoppe, MD principal investigator
University of Cologne
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rheos Baroreflex Activation Therapy System in people with Diastolic Heart Failure, run by CVRx, Inc. at 4 sites 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 4 inclusion and 6 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 21 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Assess left ventricular mass index (LVMI). (time frame: at six months post- randomization.). The study lists 2 primary outcomes in all. 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 21 Oct 2016.