Heart FailureBIO|CREATENCT03157076
Pilot Study to Investigate the Creation of Physiological Rhythm by Closed Loop Stimulation in hEart Failure pAtients With chronoTropic incompEtence
A study testing Cardiac Resynchronization therapy device with Closed Loop Stimulation (CLS) in people with Heart Failure and CPX, run by Biotronik SE & Co. KG at 1 site in Germany.
Trial summary
The study assesses the effect of Closed Loop Stimulation (CLS) on the ventilatory efficiency slope and estimates the patient responder rate to CLS in patients with severe chronotropic incompetence treated with a cardiac resynchronization therapy (CRT) device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, CPX
- What is being tested?
- Cardiac Resynchronization therapy device with Closed Loop Stimulation (CLS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 19 Apr 2017to 30 Apr 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CRT class I indication at time of implantation, according to current guidelines
- Implantation of CRT-device including CLS > 6 months prior to enrollment
- Stable heart failure status for at least 1 month
- Optimal cardiovascular drug treatment according to current guidelines
- NYHA class II or III
- Patient is able to comply with the protocol
- Patient provided written informed consent
- Stable location of residence
Who cannot join
- Planned cardiovascular intervention within the next 3 months
- Admission for decompensated heart failure or acute coronary syndrome in the preceding 3 months
- Ongoing symptoms of myocardial ischemia
- Known persistent, long-standing persistent or permanent atrial fibrillation
- COPD with GOLD ≥ 3
- Planned absence of residence for more than one week during study period
Show all 11Show fewer
- Pregnant or breast-feeding women
- Participation in another interventional clinical investigation
- Age < 18 years
- Placed in an institution due to official decree or judicial order
- Dependent from the sponsor, the clinical site or the investigators
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BIO|CREATE Pilot Study
The study assesses the effect of Closed Loop Stimulation (CLS) on the ventilatory efficiency slope and estimates the patient responder rate to CLS in patients with severe chronotropic incompetence treated with a cardiac resynchronization therapy (CRT) device.
Read the detailed description
In patients with pharmacological refractory heart failure (HF), systolic dysfunction, and cardiac dyssynchrony, the cardiac resynchronization therapy (CRT) reduces the risk of death, and improves symptoms and quality of life.
A considerable portion (80%) of patients with a CRT indication has a chronotropic incompetence (CI). CI usually induces a stress intolerance which negatively affects the quality of life. In addition of being a marker of diminished exercise capacity, severe CI (sCI) may be an independent predictor of mortality.
The sensor-based rate adaption provided by the implanted CRT device delivers a possible therapeutic approach for the CI.
Usually, rate adaption is achieved by an accelerometer. The previous studies in terms of effectiveness of rate adaption in CRT patients with CI showed inconsistent results.
In addition to an accelerometer to deliver the rate adaption BIOTRONIK provides closed loop stimulation (CLS) as unique feature in a CRT device. CLS determines the appropriate heart rate based on intra-cardiac impedance measurements. These measurements reflect changes of the cardiac contraction dynamics in reaction to information coming from the autonomic nervous system. CLS takes the information on the contraction dynamics and translates it into an adequate heart rate adaptation, thus delivering physiologically appropriate therapy.
- Conditions
- Heart Failure, CPX
- Being tested
- Cardiac Resynchronization therapy device with Closed Loop Stimulation (CLS)
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Resynchronization therapy device with Closed Loop Stimulation (CLS)Device
Also called Cardiac Resynchronization therapy device without Closed Loop Stimulation (CLS)
The feature CLS will be programmed ON or Off according to a randomization list after one month after baseline visit. One month later the alternate will be programmed.
| Study group | Role | What they receive |
|---|---|---|
| Pacing mode with CLS | Active comparator | Not described Receives: Device: Cardiac Resynchronization therapy device with Closed Loop Stimulation (CLS) |
| Intrinsic mode | Active comparator | Not described Receives: Device: Cardiac Resynchronization therapy device with Closed Loop Stimulation (CLS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilatory efficiency slope
The slope of VE/VCO2 describes the ventilatory efficiency during effort, showing the amount of air that must be ventilated to eliminate 1 litre of CO2.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start19 Apr 2017
- Primary completion31 Mar 2019
- Study completion30 Apr 2019
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.
- 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
- Crossover
- Model description
- Patients are randomized in two different pacing modes (CLS versus intrinsic rhythm) after one month after enrollment. The cross-over takes place after one month after the randomization.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mattias Roser, Dr., Principal investigator, Charité Universitätsklinikum - Campus Benjamin Franklin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03157076
- Sponsor's protocol ID
- CR019
- Acronym
- BIO|CREATE
- Status last verified
- Jan 2019
- First submitted
- 16 May 2017
- Last updated
- 24 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIO|CREATE Pilot Study
- ClinicalTrials.gov ID
- NCT03157076
- Acronym / sponsor ID
- BIO|CREATE / CR019
- Conditions
- Heart Failure, CPX
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- 19 Apr 2017 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 17 May 2017 (actual)
- 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 study assesses the effect of Closed Loop Stimulation (CLS) on the ventilatory efficiency slope and estimates the patient responder rate to CLS in patients with severe chronotropic incompetence treated with a cardiac resynchronization therapy (CRT) device.
Detailed description
In patients with pharmacological refractory heart failure (HF), systolic dysfunction, and cardiac dyssynchrony, the cardiac resynchronization therapy (CRT) reduces the risk of death, and improves symptoms and quality of life.
A considerable portion (80%) of patients with a CRT indication has a chronotropic incompetence (CI). CI usually induces a stress intolerance which negatively affects the quality of life. In addition of being a marker of diminished exercise capacity, severe CI (sCI) may be an independent predictor of mortality.
The sensor-based rate adaption provided by the implanted CRT device delivers a possible therapeutic approach for the CI.
Usually, rate adaption is achieved by an accelerometer. The previous studies in terms of effectiveness of rate adaption in CRT patients with CI showed inconsistent results.
In addition to an accelerometer to deliver the rate adaption BIOTRONIK provides closed loop stimulation (CLS) as unique feature in a CRT device. CLS determines the appropriate heart rate based on intra-cardiac impedance measurements. These measurements reflect changes of the cardiac contraction dynamics in reaction to information coming from the autonomic nervous system. CLS takes the information on the contraction dynamics and translates it into an adequate heart rate adaptation, thus delivering physiologically appropriate therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Patients are randomized in two different pacing modes (CLS versus intrinsic rhythm) after one month after enrollment. The cross-over takes place after one month after the randomization.
| Arm | Type | Receives |
|---|---|---|
| Pacing mode with CLS | Active comparator | Device: Cardiac Resynchronization therapy device with Closed Loop Stimulation (CLS) |
| Intrinsic mode | Active comparator | Device: Cardiac Resynchronization therapy device with Closed Loop Stimulation (CLS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- CRT class I indication at time of implantation, according to current guidelines
- Implantation of CRT-device including CLS > 6 months prior to enrollment
- Stable heart failure status for at least 1 month
- Optimal cardiovascular drug treatment according to current guidelines
- NYHA class II or III
Key exclusion criteria (11 listed)
- Planned cardiovascular intervention within the next 3 months
- Admission for decompensated heart failure or acute coronary syndrome in the preceding 3 months
- Ongoing symptoms of myocardial ischemia
- Known persistent, long-standing persistent or permanent atrial fibrillation
- COPD with GOLD ≥ 3
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 |
|---|---|---|
| Cardiac Resynchronization therapy device with Closed Loop Stimulation (CLS)Also: Cardiac Resynchronization therapy device without Closed Loop Stimulation (CLS)The feature CLS will be programmed ON or Off according to a randomization list after one month after baseline visit. One month later the alternate will be programmed. | Device | Intrinsic mode, Pacing mode with CLS |
Primary outcome
Ventilatory efficiency slope
Time frame: 2 months
The slope of VE/VCO2 describes the ventilatory efficiency during effort, showing the amount of air that must be ventilated to eliminate 1 litre of CO2.
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 24 May 2019.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
Mattias Roser, Dr. principal investigator
Charité Universitätsklinikum - Campus Benjamin Franklin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Resynchronization therapy device with Closed Loop Stimulation (CLS) in people with Heart Failure and CPX, run by Biotronik SE & Co. KG 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 8 inclusion and 11 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 24 May 2019. 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?
Ventilatory efficiency slope (time frame: 2 months). 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 24 May 2019.