CardiomyopathiesNCT05600725
Novel Cardiac Pacing to Initiate Cardiac Remodeling in Heart Failure
A study testing novel atrial pacing approach in people with Cardiomyopathies and Heart Rate, run by Denise Hodgson-Zingman at 1 site in United States.
Trial summary
This project utilizes a novel cardiac pacing approach hypothesized to initiate beneficial cardiac conditioning and remodeling over a period of time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiomyopathies, Heart Rate, Conditioning
- What is being tested?
- novel atrial pacing approach
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2022to 28 Feb 2023
- 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
- Non-Ischemic Cardiomyopathy
- Ejection Fraction </= 35% despite at least 3 months stable standard medical management
- New York Heart Association Class II-III symptoms
- Dual chamber implantable cardioverter defibrillator in place or Biventricular ICD in place (over 3 months old)
- Normal Atrioventricular conduction or Biventricular ICD
- QRS < 120 msec (inherent conduction or paced with BiV ICD)
Who cannot join
- Age < 18 years
- Inability to ambulate safely
- Congenital or primary valve disease
- Left Ventricular thrombus
- Severe peripheral arterial disease
- Admission for life-threatening condition (eg heart failure, stroke) in the past 3 months
Show all 16Show fewer
- Major surgery in the past 3 months or anticipated during the period of the trial
- Paced or intrinsic QRS >120 msec
- Life expectancy < 1 year
- Hemodialysis
- Hematocrit < 30%
- Severe Chronic lung disease
- Pregnancy
- ICD battery longevity < 1 year
- Unsuppressed atrial arrhythmias
- Already participating in an exercise programusion Criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Novel Pacing Modality to Initiate Favorable Cardiac Remodeling in Heart Disease
This project utilizes a novel cardiac pacing approach hypothesized to initiate beneficial cardiac conditioning and remodeling over a period of time.
Read the detailed description
The project studies subjects with non-ischemic cardiomyopathy who have a pacing device already implanted. Subjects randomized to the pacing intervention versus a sham intervention will be compared for various symptomatic, functional and other outcomes. Each subject will undergo baseline quality of life/symptom questionnaires and clinical testing for cardiac functional/structural effects and exercise tolerance, then the intervention vs. sham (subjects blinded to their category), followed by repeat questionnaires and clinical testing. Medical record review will be undertaken to establish demographic variables, baseline and follow up testing results.
- Conditions
- Cardiomyopathies, Heart Rate, Conditioning
- Being tested
- novel atrial pacing approach, sham pacing approach
- Medical subject headings
- Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
novel atrial pacing approachOther
See US Patent #10987516. An atrial pacing method that preserves atrioventricular and interventricular synchrony to reproduce an exercise-typical envelope of heart rate.
sham pacing approachOther
A pacemaker/ICD interrogator/programmer will be used to simulate changes in pacing rate over the same time period as the intervention group but the programming changes will not actually be implemented and not change in paced heart rate will occur.
| Study group | Role | What they receive |
|---|---|---|
| Pacing intervention | Experimental | A novel atrial pacing approach will be delivered using the subject's already implanted pacemaker, ICD or BiV/ICD while the subject is in a semi-recumbent position and while hemodynamic and symptom data is collected. This will be repeated once daily, 3d/wk over 4 weeks. Receives: Other: novel atrial pacing approach |
| Sham pacing | Sham comparator | Subjects in this arm will be treated identically to the subjects in the pacing intervention arm but their already implanted pacemaker, ICD or BiV/ICD will have programming changes simulated but not actually implemented. Receives: Other: sham pacing approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life/symptom score
Minnesota Living with Heart Failure Score (range 0-105, higher scores indicate worse quality of life)
Measured: 4 weeks after start of the protocol
Secondary outcomes (6)
systolic blood pressure
systolic blood pressure (mmHg) as a continuous variable
Measured: every 5 minutes during intervention/sham in weeks 1-4 of the protocol
diastolic blood pressure
systolic blood pressure (mmHg) as a continuous variable
Measured: every 5 minutes during intervention/sham in weeks 1-4 of the protocol
Oxygen saturation
oxygen saturation by pulse oximeter (%) as a continuous variable
Measured: every 5 minutes during intervention/sham in weeks 1-4 of the protocol
cardiac output
cardiac output (liters/minute) as measured by thoracic impedance and reported as a continuous variable
Measured: every 5 minutes during intervention/sham in weeks 1-4 of the protocol
MACE
Major adverse cardiac events: composite of total death, MI, stroke, hospitalization due to heart failure, revascularization
Measured: 4 weeks and 4 months after start of the protocol
six minute walk
distance ambulated in 6 minutes (meters)
Measured: at the time of enrollment, and at 4 weeks after start of the protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start2 Nov 2022
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiomyopathiesStudies 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
- Model description
- Subjects will be randomized in a single-blinded fashion to intervention vs. sham treatment
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Denise Hodgson-Zingman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Denise Hodgson-Zingman, University of Iowa
- Investigators
- Denice Hodgson-Zingman, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05600725
- Sponsor's protocol ID
- 202202351
- Status last verified
- May 2023
- First submitted
- 27 Jun 2022
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Pacing Modality to Initiate Favorable Cardiac Remodeling in Heart Disease
- ClinicalTrials.gov ID
- NCT05600725
- Acronym / sponsor ID
- 202202351
- Conditions
- Cardiomyopathies, Heart Rate, Conditioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Denise Hodgson-ZingmanUniversity, hospital or other
- Study start
- 2 Nov 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 31 Oct 2022 (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.
This project utilizes a novel cardiac pacing approach hypothesized to initiate beneficial cardiac conditioning and remodeling over a period of time.
Detailed description
The project studies subjects with non-ischemic cardiomyopathy who have a pacing device already implanted. Subjects randomized to the pacing intervention versus a sham intervention will be compared for various symptomatic, functional and other outcomes. Each subject will undergo baseline quality of life/symptom questionnaires and clinical testing for cardiac functional/structural effects and exercise tolerance, then the intervention vs. sham (subjects blinded to their category), followed by repeat questionnaires and clinical testing. Medical record review will be undertaken to establish demographic variables, baseline and follow up testing results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be randomized in a single-blinded fashion to intervention vs. sham treatment
| Arm | Type | Receives |
|---|---|---|
| Pacing intervention | Experimental | Other: novel atrial pacing approachA novel atrial pacing approach will be delivered using the subject's already implanted pacemaker, ICD or BiV/ICD while the subject is in a semi-recumbent position and while hemodynamic and symptom data is collected. This will be repeated once daily, 3d/wk over 4 weeks. |
| Sham pacing | Sham comparator | Other: sham pacing approachSubjects in this arm will be treated identically to the subjects in the pacing intervention arm but their already implanted pacemaker, ICD or BiV/ICD will have programming changes simulated but not actually implemented. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Non-Ischemic Cardiomyopathy
- Ejection Fraction </= 35% despite at least 3 months stable standard medical management
- New York Heart Association Class II-III symptoms
- Dual chamber implantable cardioverter defibrillator in place or Biventricular ICD in place (over 3 months old)
- Normal Atrioventricular conduction or Biventricular ICD
Key exclusion criteria (16 listed)
- Age < 18 years
- Inability to ambulate safely
- Congenital or primary valve disease
- Left Ventricular thrombus
- Severe peripheral arterial 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 |
|---|---|---|
| novel atrial pacing approachSee US Patent #10987516. An atrial pacing method that preserves atrioventricular and interventricular synchrony to reproduce an exercise-typical envelope of heart rate. | Other | Pacing intervention |
| sham pacing approachA pacemaker/ICD interrogator/programmer will be used to simulate changes in pacing rate over the same time period as the intervention group but the programming changes will not actually be implemented and not change in paced heart rate will occur. | Other | Sham pacing |
Primary outcome
Quality of life/symptom score
Time frame: 4 weeks after start of the protocol
Minnesota Living with Heart Failure Score (range 0-105, higher scores indicate worse quality of life)
6 secondary outcomes
systolic blood pressure
Time frame: every 5 minutes during intervention/sham in weeks 1-4 of the protocol
diastolic blood pressure
Time frame: every 5 minutes during intervention/sham in weeks 1-4 of the protocol
Oxygen saturation
Time frame: every 5 minutes during intervention/sham in weeks 1-4 of the protocol
cardiac output
Time frame: every 5 minutes during intervention/sham in weeks 1-4 of the protocol
MACE
Time frame: 4 weeks and 4 months after start of the protocol
six minute walk
Time frame: at the time of enrollment, and at 4 weeks after start of the protocol
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 16 May 2023.
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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.
Denice Hodgson-Zingman, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing novel atrial pacing approach in people with Cardiomyopathies and Heart Rate, run by Denise Hodgson-Zingman 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 16 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 16 May 2023. 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. Some participants in this study may receive a placebo. 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?
Quality of life/symptom score (time frame: 4 weeks after start of the protocol). 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 16 May 2023.