Cardiogenic ShockNCT06713668
Augmented Pacing for Shock in the Cardiac Intensive Care Unit
A study testing Backup Pacing Rate Change in people with Cardiogenic Shock and Bradycardia, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if backup pacing at an increased rate improves hemodynamics in adults with relative bradycardia, a permanent pacemaker, and cardiogenic shock. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock, Bradycardia, Shock
- What is being tested?
- Backup Pacing Rate Change
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2025to 22 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adults (age 18 and older)
- Located in the CVICU
- FDA approved permanent pacemaker in place (inclusive of dual-chamber and Bi-Ventricular ICDs) with labeling that allows backup pacing setting at 100 bpm.
- Receiving a vasopressor or Inotrope for at least 4 hours
- Average HR ≤ 75 bpm over the last hour (on Telemetry review)
- Pulmonary artery catheter in place with functioning thermistor and pulmonary artery port.
Who cannot join
- Single chamber Implantable Cardiac Defibrillator
- Sinus rhythm with a leadless pacemaker
- Ventricular Tachycardia or Ventricular Fibrillation arrest in last 48 hours
- Hemodynamic instability within the last 4 hours, defined as an increase in the dose of norepinephrine > 10 mcg/min, an increase of epinephrine > 10 mcg/kg/min, or initiation of a second vasopressor
- Alternative indication for pacing rate change (i.e Torsade de Pointes, Recurrent Ventricular Tachycardia)
- Comfort-focused care or anticipated death within 24 hours
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- Mechanical circulatory support in place
- Newly discovered pacing system malfunction (lead displacement, loss of capture, elevated capture threshold, significant lead impedance change, battery depletion, undersensing or oversensing)
- Non-English Speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Augmented Pacing for Shock in the Cardiac Intensive Care Unit - A Pilot Patient-level Crossover Trial
The goal of this clinical trial is to learn if backup pacing at an increased rate improves hemodynamics in adults with relative bradycardia, a permanent pacemaker, and cardiogenic shock. The main question it aims to answer is:
Does increasing the backup pacing rate to 100 beats per minute lead to improved cardiac index compared to a backup pacing rate of 75 beats per minute
Participants who are already hospitalized in the Cardiovascular Intensive Care Unit with a permanent pacemaker and pulmonary artery catheter in place will be enrolled in this study. Participants will be exposed to each pacemaker rate in a randomized order with hemodynamics assessed after 10 minutes at each rate.
- Conditions
- Cardiogenic Shock, Bradycardia, Shock
- Being tested
- Backup Pacing Rate Change
- Keywords
- Cardiogenic Shock, Bradycardia, Shock, Pacing
- Medical subject headings
- Shock, Cardiogenic, Bradycardia, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Backup Pacing Rate ChangeDevice
Patients will have backup pacing programmed to A (75 bpm) and B (100 bpm), randomizing to sequence of exposure A-B or B-A
| Study group | Role | What they receive |
|---|---|---|
| Standard Pacing (75 bpm) then Augmented Pacing (100 bpm) | Other | Backup pacing rate will be set to 75 bpm first then 100 bpm second Receives: Device: Backup Pacing Rate Change |
| Augmented Pacing Rate (100 bpm) then Standard Pacing (75 bpm) | Other | Backup pacing rate will be set to 100 bpm first then 75 bpm second Receives: Device: Backup Pacing Rate Change |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Index by thermodilution
Cardiac Index measured by thermodilution (in liters per minute per meters squared)
Measured: At baseline and 10 minutes after each rate programmed (i.e at 0, 15, and 30 minutes)
Secondary outcomes (18)
Cardiac Index by Indirect Fick
Measured: 0, 15, 30 minutes.
Cardiac Output by thermodilution
Measured: 0, 15, 30 minutes.
Cardiac Output by indirect fick
Measured: 0 ,15, 30 minutes
Central Venous Pressure
Measured: 0, 15, 30 minutes
Pulmonary Artery Systolic Pressure
Measured: 0, 15, 30 minutes
Pulmonary Artery Diastolic Pressure
Measured: 0, 15, 30 minutes
Pulmonary Artery Pulsitility Index
Measured: 0, 15, 30 minutes
Right Ventricular Stroke Work Index
Measured: 0, 15, 30 minutes
Pulmonary Artery (Mixed Venous) Blood Hemoglobin saturation
Measured: 0, 15, 30 minutes
Cardiac Power Index (Thermodilution and indirect fick)
Measured: 0, 15, 30 minutes
Cardiac Power Output (Thermodilution and indirect fick)
Measured: 0, 15, 30 minutes
Systolic Blood pressure
Measured: 0, 15, 30 minutes
Diastolic Blood Pressure
Measured: 0, 15, 30 minutes
Mean Arterial Pressure
Measured: 0, 15, 30 minutes
Difference in vasopressor/inotrope requirements
Measured: 0, 15, 30 minutes
Arrhythmia events (Atrial and Ventricular)
Measured: 0, 15, 30 minutes
Percentage of PVCs
Measured: 0, 15, 30 minutes
Pacing percentage (Atrial, RV or Bi-V)
Measured: 0, 15, 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start22 Apr 2025
- Primary completion22 Apr 2027 (estimated)
- Study completion22 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JGarry, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06713668
- Sponsor's protocol ID
- 241410
- Status last verified
- May 2026
- First submitted
- 1 Nov 2024
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmented Pacing for Shock in the Cardiac Intensive Care Unit - A Pilot Patient-level Crossover Trial
- ClinicalTrials.gov ID
- NCT06713668
- Acronym / sponsor ID
- 241410
- Conditions
- Cardiogenic Shock, Bradycardia, Shock
- Keywords
- Cardiogenic Shock, Bradycardia, Shock, Pacing
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- 22 Apr 2027 (estimated)
- Study completion
- 22 Apr 2027 (estimated)
- First posted
- 3 Dec 2024 (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 goal of this clinical trial is to learn if backup pacing at an increased rate improves hemodynamics in adults with relative bradycardia, a permanent pacemaker, and cardiogenic shock. The main question it aims to answer is:
Does increasing the backup pacing rate to 100 beats per minute lead to improved cardiac index compared to a backup pacing rate of 75 beats per minute
Participants who are already hospitalized in the Cardiovascular Intensive Care Unit with a permanent pacemaker and pulmonary artery catheter in place will be enrolled in this study. Participants will be exposed to each pacemaker rate in a randomized order with hemodynamics assessed after 10 minutes at each rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Pacing (75 bpm) then Augmented Pacing (100 bpm) | Other | Device: Backup Pacing Rate ChangeBackup pacing rate will be set to 75 bpm first then 100 bpm second |
| Augmented Pacing Rate (100 bpm) then Standard Pacing (75 bpm) | Other | Device: Backup Pacing Rate ChangeBackup pacing rate will be set to 100 bpm first then 75 bpm second |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults (age 18 and older)
- Located in the CVICU
- FDA approved permanent pacemaker in place (inclusive of dual-chamber and Bi-Ventricular ICDs) with labeling that allows backup pacing setting at 100 bpm.
- Receiving a vasopressor or Inotrope for at least 4 hours
- Average HR ≤ 75 bpm over the last hour (on Telemetry review)
Key exclusion criteria (9 listed)
- Single chamber Implantable Cardiac Defibrillator
- Sinus rhythm with a leadless pacemaker
- Ventricular Tachycardia or Ventricular Fibrillation arrest in last 48 hours
- Hemodynamic instability within the last 4 hours, defined as an increase in the dose of norepinephrine > 10 mcg/min, an increase of epinephrine > 10 mcg/kg/min, or initiation of a second vasopressor
- Alternative indication for pacing rate change (i.e Torsade de Pointes, Recurrent Ventricular Tachycardia)
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 |
|---|---|---|
| Backup Pacing Rate ChangePatients will have backup pacing programmed to A (75 bpm) and B (100 bpm), randomizing to sequence of exposure A-B or B-A | Device | Augmented Pacing Rate (100 bpm) then Standard Pacing (75 bpm), Standard Pacing (75 bpm) then Augmented Pacing (100 bpm) |
Primary outcome
Cardiac Index by thermodilution
Time frame: At baseline and 10 minutes after each rate programmed (i.e at 0, 15, and 30 minutes)
Cardiac Index measured by thermodilution (in liters per minute per meters squared)
18 secondary outcomes
Cardiac Index by Indirect Fick
Time frame: 0, 15, 30 minutes.
Cardiac Output by thermodilution
Time frame: 0, 15, 30 minutes.
Cardiac Output by indirect fick
Time frame: 0 ,15, 30 minutes
Central Venous Pressure
Time frame: 0, 15, 30 minutes
Pulmonary Artery Systolic Pressure
Time frame: 0, 15, 30 minutes
Pulmonary Artery Diastolic Pressure
Time frame: 0, 15, 30 minutes
Pulmonary Artery Pulsitility Index
Time frame: 0, 15, 30 minutes
Right Ventricular Stroke Work Index
Time frame: 0, 15, 30 minutes
Pulmonary Artery (Mixed Venous) Blood Hemoglobin saturation
Time frame: 0, 15, 30 minutes
Cardiac Power Index (Thermodilution and indirect fick)
Time frame: 0, 15, 30 minutes
Cardiac Power Output (Thermodilution and indirect fick)
Time frame: 0, 15, 30 minutes
Systolic Blood pressure
Time frame: 0, 15, 30 minutes
Diastolic Blood Pressure
Time frame: 0, 15, 30 minutes
Mean Arterial Pressure
Time frame: 0, 15, 30 minutes
Difference in vasopressor/inotrope requirements
Time frame: 0, 15, 30 minutes
Arrhythmia events (Atrial and Ventricular)
Time frame: 0, 15, 30 minutes
Percentage of PVCs
Time frame: 0, 15, 30 minutes
Pacing percentage (Atrial, RV or Bi-V)
Time frame: 0, 15, 30 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Backup Pacing Rate Change in people with Cardiogenic Shock and Bradycardia, run by Vanderbilt University Medical Center at 1 site in United States.
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 9 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: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Cardiac Index by thermodilution (time frame: At baseline and 10 minutes after each rate programmed (i.e at 0, 15, and 30 minutes)). 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 6 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.