Diastolic FunctionPADIACNCT04068233
Impact of Pacing Mode and Diastolic Function on Cardiac Output
A study testing Pacemaker stimulation mode in people with Diastolic Function and Cardiac Output, run by Kepler University Hospital at 1 site in Austria.
Trial summary
Background It is known from previous research that in patients with complete AV (atrioventricular) block and pacemaker stimulation stroke volume and cardiac output are higher with AV-synchronous than with AV-dyssynchronous pacing. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Diastolic Function, Cardiac Output, Pacemaker Stimulation Mode
- What is being tested?
- Pacemaker stimulation mode
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- 26 Jun 2019to 5 Feb 2020
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient is able and willing to give informed consent and is above the age of 18.
- Patient is implanted with a dual chamber pacemaker system for at least 6 weeks.
- Patient is in sinus rhythm on the day of recruitment.
- Patient has a ventricular pacing rate exceeding 90%.
- Upon initial device interrogation, parameters are within normal ranges.
- Calculated battery life is more than 1 year.
Who cannot join
- Patient is not in sinus rhythm on the day of echo examination.
- Intrinsic ventricular activation on the day of echo examination.
- Relevant shunt on the atrial, ventricular or pulmonary level.
- Moderate or severe heart valve dysfunction (stenosis or regurgitation).
- Presence of other medical devices that may interact with the pacemaker system.
- Women who are pregnant or breast feeding.
Trial locations and contacts
1 site in 1 country.
About this study
Background It is known from previous research that in patients with complete AV (atrioventricular) block and pacemaker stimulation stroke volume and cardiac output are higher with AV-synchronous than with AV-dyssynchronous pacing. However, the extent to which patients profited from AV-synchronous stimulation varied substantially.
Aim of the study Aim of this study is to systematically analyze the impact of diastolic function and other echo parameters on the difference of stroke volumes/cardiac output between AV-synchronous and AV-dyssynchronous pacing modes.
Methods Patients fulfilling the entry criteria will be enrolled (two-chamber pacemaker of any vendor eligible) in this monocentric, prospective, interventional study. Baseline data will be collected with a standardized questionnaire. During an echo examination, parameters of diastolic, systolic and atrial function will be assessed. Then, the stroke volume/cardiac output will be measured twice in each patient, once with AV-synchronous and once with AV-dyssynchronous pacing. Therefore, each patient will represent their own control. It will be randomized (coin tossing) which stimulation mode is first and which is second (sonographer and patient will be blinded). Descriptive statistics will be applied and regression models will be fitted to explore the data.
- Being tested
- Pacemaker stimulation mode
- Keywords
- Diastolic function, Cardiac output, Pacemaker stimulation mode, Stroke volume
- Medical subject headings
- Atrioventricular Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacemaker stimulation modeOther
Echocardiographic indices are measured during AV asynchronous and AV synchronous pacemaker stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Eligible patients - pacing mode sequence 1 | Experimental | Echo assessment of parameters of diastolic function, systolic function, and atrial function. Then, the stroke volume and cardiac output are measured during AV-asynchronous and AV-synchronous pacemaker stimulation: AV-synchronous pacing mode first, then AV-dyssynchronous pacing mode. Receives: Other: Pacemaker stimulation mode |
| Eligible patients - pacing mode sequence 2 | Experimental | Echo assessment of parameters of diastolic function, systolic function, and atrial function. Then, the stroke volume and cardiac output are measured during AV-asynchronous and AV-synchronous pacemaker stimulation: AV-dyssynchronous pacing mode first, then AV-synchronous pacing mode. Receives: Other: Pacemaker stimulation mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of left ventricular diastolic function on the change of cardiac output between AV-synchronous and AV-asynchronous pacing modes.
Echo parameters of diastolic function.
Measured: During echo examination.
Secondary outcomes (3)
Effect of left ventricular systolic function on the change of cardiac output between AV-synchronous and AV-asynchronous pacing modes.
Echo parameters of systolic function.
Measured: During echo examination.
Effect of atrial function on the change of cardiac output between AV-synchronous and AV-asynchronous pacing modes.
Echo parameters of atrial function.
Measured: During echo examination.
Effect of baseline characteristics on the change of cardiac output between AV-synchronous and AV-asynchronous pacing modes.
Demographic variables and co-morbidities.
Measured: During echo examination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start26 Jun 2019
- Primary completion5 Feb 2020
- Study completion5 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diastolic FunctionStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each patient will represent their own control, as both pacing modes (asynchronous and synchronous) are applied in each patient.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kepler University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Clemens Steinwender, Kepler University Hospital
- Investigators
- Clemens Steinwender, Assoc. Prof., MD, Principal investigator, Kepler University Hospital, Department of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04068233
- Sponsor's protocol ID
- 01/2019
- Acronym
- PADIAC
- Status last verified
- Feb 2020
- First submitted
- 22 Aug 2019
- Last updated
- 21 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blessberger H, Kammler J, Kellermair J, Kiblboeck D, Nahler A, Hrncic D, Saleh K, Schwarz S, Reiter C, Fellner A, Eppacher C, Sheldon TJ, Steinwender C. Impact of pacing mode and different echocardiographic parameters on cardiac output (PADIAC). Front Cardiovasc Med. 2023 May 17;10:1185518. doi: 10.3389/fcvm.2023.1185518. eCollection 2023.
PubMed 37265566
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pacing Mode and Diastolic Function on Cardiac Output
- ClinicalTrials.gov ID
- NCT04068233
- Acronym / sponsor ID
- PADIAC / 01/2019
- Keywords
- Diastolic function, Cardiac output, Pacemaker stimulation mode, Stroke volume
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kepler University HospitalUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 26 Jun 2019 (actual)
- Primary completion
- 5 Feb 2020 (actual)
- Study completion
- 5 Feb 2020 (actual)
- First posted
- 28 Aug 2019 (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.
Background It is known from previous research that in patients with complete AV (atrioventricular) block and pacemaker stimulation stroke volume and cardiac output are higher with AV-synchronous than with AV-dyssynchronous pacing. However, the extent to which patients profited from AV-synchronous stimulation varied substantially.
Aim of the study Aim of this study is to systematically analyze the impact of diastolic function and other echo parameters on the difference of stroke volumes/cardiac output between AV-synchronous and AV-dyssynchronous pacing modes.
Methods Patients fulfilling the entry criteria will be enrolled (two-chamber pacemaker of any vendor eligible) in this monocentric, prospective, interventional study. Baseline data will be collected with a standardized questionnaire. During an echo examination, parameters of diastolic, systolic and atrial function will be assessed. Then, the stroke volume/cardiac output will be measured twice in each patient, once with AV-synchronous and once with AV-dyssynchronous pacing. Therefore, each patient will represent their own control. It will be randomized (coin tossing) which stimulation mode is first and which is second (sonographer and patient will be blinded). Descriptive statistics will be applied and regression models will be fitted to explore the data.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Each patient will represent their own control, as both pacing modes (asynchronous and synchronous) are applied in each patient.
| Arm | Type | Receives |
|---|---|---|
| Eligible patients - pacing mode sequence 1 | Experimental | Other: Pacemaker stimulation modeEcho assessment of parameters of diastolic function, systolic function, and atrial function. Then, the stroke volume and cardiac output are measured during AV-asynchronous and AV-synchronous pacemaker stimulation: AV-synchronous pacing mode first, then AV-dyssynchronous pacing mode. |
| Eligible patients - pacing mode sequence 2 | Experimental | Other: Pacemaker stimulation modeEcho assessment of parameters of diastolic function, systolic function, and atrial function. Then, the stroke volume and cardiac output are measured during AV-asynchronous and AV-synchronous pacemaker stimulation: AV-dyssynchronous pacing mode first, then AV-synchronous pacing mode. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient is able and willing to give informed consent and is above the age of 18.
- Patient is implanted with a dual chamber pacemaker system for at least 6 weeks.
- Patient is in sinus rhythm on the day of recruitment.
- Patient has a ventricular pacing rate exceeding 90%.
- Upon initial device interrogation, parameters are within normal ranges.
Key exclusion criteria (6 listed)
- Patient is not in sinus rhythm on the day of echo examination.
- Intrinsic ventricular activation on the day of echo examination.
- Relevant shunt on the atrial, ventricular or pulmonary level.
- Moderate or severe heart valve dysfunction (stenosis or regurgitation).
- Presence of other medical devices that may interact with the pacemaker system.
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 |
|---|---|---|
| Pacemaker stimulation modeEchocardiographic indices are measured during AV asynchronous and AV synchronous pacemaker stimulation. | Other | Eligible patients - pacing mode sequence 1, Eligible patients - pacing mode sequence 2 |
Primary outcome
Effect of left ventricular diastolic function on the change of cardiac output between AV-synchronous and AV-asynchronous pacing modes.
Time frame: During echo examination.
Echo parameters of diastolic function.
3 secondary outcomes
Effect of left ventricular systolic function on the change of cardiac output between AV-synchronous and AV-asynchronous pacing modes.
Time frame: During echo examination.
Effect of atrial function on the change of cardiac output between AV-synchronous and AV-asynchronous pacing modes.
Time frame: During echo examination.
Effect of baseline characteristics on the change of cardiac output between AV-synchronous and AV-asynchronous pacing modes.
Time frame: During echo examination.
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 Feb 2020.
- Derived from this study: PubMed 37265566Blessberger H, Kammler J, Kellermair J, Kiblboeck D, Nahler A, Hrncic D, Saleh K, Schwarz S, Reiter C, Fellner A, Eppacher C, Sheldon TJ, Steinwender C. Impact of pacing mode and different echocardiographic parameters on cardiac output (PADIAC). Front Cardiovasc Med. 2023 May 17;10:1185518. doi: 10.3389/fcvm.2023.1185518. eCollection 2023.
- 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.
Clemens Steinwender, Assoc. Prof., MD principal investigator
Kepler University Hospital, Department of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pacemaker stimulation mode in people with Diastolic Function and Cardiac Output, run by Kepler University Hospital at 1 site in Austria.
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 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 Feb 2020. 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 Austria. 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?
Effect of left ventricular diastolic function on the change of cardiac output between AV-synchronous and AV-asynchronous pacing modes. (time frame: During echo examination.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04068233, which also lists 1 linked publication.
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 Feb 2020.