Heart FailureNCT03420833

Metabolic Mapping and Cardiac Resynchronization

A study testing Cardiac resynchronization therapy pacemaker (CRT-P) in people with Heart Failure, run by Yong-Mei Cha at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to gather information on the safety and effectiveness of cardiac resynchronization therapy (CRT) in patients who have mild heart failure (HF) and left bundle branch block (LBBB). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Heart Failure
What is being tested?: Cardiac resynchronization therapy pacemaker (CRT-P)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 82 participants
Where: 1 siteUnited States
Study dates: 20 Aug 2018to 19 Dec 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Left Ventricular Ejection Fraction (LVEF) 35%-50%
New York Heart Association (NYHA) class I-II
QRS duration of ≥120ms
Left bundle branch block (LBBB)
Patient is able to receive a transvenous pectoral CRT implant
Patient is able to sign informed consent
Two echocardiograms are required to confirm a stable reduced LVEF
Patient is on optimal and stable medical therapy (ACE inhibitor or angiotensin II type 1 (AT1 )blocker, beta blocker, etc. over the last 6 months)

Who cannot join

Advanced comorbid conditions with life expectancy <1 year
Patient is <18 of years of age
Patient has a CRT device
Female patients who is pregnant or not on a reliable form of birth control. Women of childbearing potential are required to have negative pregnancy test within the 7 days prior to device implant
Unwilling or unable to return for required follow-up visits
Patient decides study participation is cost-prohibited

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic in Rochester
Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Metabolic Mapping and Cardiac Resynchronization (Aim 1)

Conditions: Heart Failure
Being tested: Cardiac resynchronization therapy pacemaker (CRT-P)
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 pacemaker (CRT-P)Device
Also called BIOTRONIK Evia HF-T
A pacemaker is an implantable, battery-powered minicomputer that sends electrical pulses to the heart whenever it detects a slow heartbeat or no heartbeat at all. When it senses a slow heartbeat or lack of heartbeat, it sends electrical impulses to restore a normal rhythm. Cardiac resynchronization therapy pacemakers, or CRT-Ps, treat heart failure by resynchronizing electrical impulses in the heart's four chambers, improving the heart's ability to pump blood to the body effectively and efficiently.

Study groups in NCT03420833
Study group	Role	What they receive
CRT-On first, then CRT-Off	Experimental	Subjects will be randomized to have the cardiac resynchronization therapy pacemaker (CRT-P) programmed on in the first intervention period, and after six months the CRT function will be turned off in the second intervention period. Receives: Device: Cardiac resynchronization therapy pacemaker (CRT-P)
CRT-Off first, then CRT-On	Experimental	Subjects will be randomized to have the cardiac resynchronization therapy pacemaker (CRT-P) programmed off in the first intervention period, and after six months the CRT function will be turned on in the second intervention period. Receives: Device: Cardiac resynchronization therapy pacemaker (CRT-P)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Left Ventricle End-Systolic Volume Index (LVESVI)
LVESVI is the volume of blood in the left ventricle at the end of contraction, or systole, adjusted for the individual's body surface area.
Measured: baseline, 12 months
Number of Subjects Experiencing Any System-Related Complications
This is a composite endpoint; system-related complications could include any of the following: device pocket hematoma, pneumothorax, myocardial perforation, lead dislodgement, lead revision and device-related infection.
Measured: Approximately 12 months

Secondary outcomes (5)

Number of Subjects Admitted to the Hospital for Heart Failure
The total number of subjects hospitalized for heart failure during the study.
Measured: Approximately 12 months
Change in N-Terminal Pro B-Type Natriuretic Peptide (NT-proBNP) by CRT Randomization From 6 Months to 12 Months
The NT-proBNP is a substance that is produced in the heart and released when the heart is stretched and working hard to pump blood, measured in pg/mL. The change was calculated as the value at 12 months minus the value at 6 months.
Measured: 6 months, 12 months
Number of Subjects Who Experience Sustained Ventricular Tachycardia or Fibrillation Greater Than 30 Seconds
In ventricular tachycardia, abnormal electrical signals in the ventricles cause the heart to beat faster than normal, usually 100 or more beats a minute, out of sync with the upper chambers. Ventricular fibrillation is the most serious cardiac rhythm disturbance. The lower chambers quiver and the heart can't pump any blood, causing cardiac arrest.
Measured: Approximately 12 months
Change in Left Ventricular Ejection Fraction (LVEF)
LVEF refers to how well your left ventricle (or right ventricle) pumps blood with each heart beat. Most times, EF refers to the amount of blood being pumped out of the left ventricle each time it contracts. The left ventricle is the heart's main pumping chamber.
Measured: Baseline, 12 months
Number of Subjects Who Die in One Year
The total number of subjects to die for any reason during the study.
Measured: Approximately 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Aug 201819 Dec 2023

First posted5 Feb 2018
Study start20 Aug 2018
Primary completion19 Dec 2023
Study completion19 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Basic science
Allocation: Randomised
Intervention model: Crossover
Model description: Single-center, randomized cross-over study
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 82 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03420833
Sponsor's protocol ID: 17-003359
Other IDs: 1R01HL134864-01A1
Status last verified: Jan 2025
First submitted: 29 Jan 2018
Last updated: 23 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Active, not recruiting
Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
Chronic Heart Failure, Heart Transplant Recipient
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Not yet recruitingObservational study
Real-world Effectiveness and Safety of Savagen (Sacubitril/Valsartan) in Malaysian HFrEF Patients
Heart Failure With Reduced Ejection Fraction (HFrEF), Heart Failure

All Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Metabolic Mapping and Cardiac Resynchronization (Aim 1)
ClinicalTrials.gov ID: NCT03420833
Acronym / sponsor ID: 17-003359
Conditions: Heart Failure
Study type: Interventional
Recruitment status: Completed
Enrolment: 82 participants (actual)
Lead sponsor: Yong-Mei ChaUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI), Biotronik SE & Co. KG
Study start: 20 Aug 2018 (actual)
Primary completion: 19 Dec 2023 (actual)
Study completion: 19 Dec 2023 (actual)
First posted: 5 Feb 2018 (actual)
Results: Posted 23 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: Single-center, randomized cross-over study

Arm	Type	Receives
CRT-On first, then CRT-Off	Experimental	Device: Cardiac resynchronization therapy pacemaker (CRT-P)Subjects will be randomized to have the cardiac resynchronization therapy pacemaker (CRT-P) programmed on in the first intervention period, and after six months the CRT function will be turned off in the second intervention period.
CRT-Off first, then CRT-On	Experimental	Device: Cardiac resynchronization therapy pacemaker (CRT-P)Subjects will be randomized to have the cardiac resynchronization therapy pacemaker (CRT-P) programmed off in the first intervention period, and after six months the CRT function will be turned on in the second intervention period.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Left Ventricular Ejection Fraction (LVEF) 35%-50%
New York Heart Association (NYHA) class I-II
QRS duration of ≥120ms
Left bundle branch block (LBBB)
Patient is able to receive a transvenous pectoral CRT implant

Key exclusion criteria (6 listed)

Advanced comorbid conditions with life expectancy <1 year
Patient is <18 of years of age
Patient has a CRT device
Female patients who is pregnant or not on a reliable form of birth control. Women of childbearing potential are required to have negative pregnancy test within the 7 days prior to device implant
Unwilling or unable to return for required follow-up visits

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 pacemaker (CRT-P)Also: BIOTRONIK Evia HF-TA pacemaker is an implantable, battery-powered minicomputer that sends electrical pulses to the heart whenever it detects a slow heartbeat or no heartbeat at all. When it senses a slow heartbeat or lack of heartbeat, it sends electrical impulses to restore a normal rhythm. Cardiac resynchronization therapy pacemakers, or CRT-Ps, treat heart failure by resynchronizing electrical impulses in the heart's four chambers, improving the heart's ability to pump blood to the body effectively and efficiently.	Device	CRT-Off first, then CRT-On, CRT-On first, then CRT-Off

Primary outcome

Change in Left Ventricle End-Systolic Volume Index (LVESVI)
Time frame: baseline, 12 months
LVESVI is the volume of blood in the left ventricle at the end of contraction, or systole, adjusted for the individual's body surface area.
Number of Subjects Experiencing Any System-Related Complications
Time frame: Approximately 12 months
This is a composite endpoint; system-related complications could include any of the following: device pocket hematoma, pneumothorax, myocardial perforation, lead dislodgement, lead revision and device-related infection.

5 secondary outcomes

Number of Subjects Admitted to the Hospital for Heart Failure
Time frame: Approximately 12 months
Change in N-Terminal Pro B-Type Natriuretic Peptide (NT-proBNP) by CRT Randomization From 6 Months to 12 Months
Time frame: 6 months, 12 months
Number of Subjects Who Experience Sustained Ventricular Tachycardia or Fibrillation Greater Than 30 Seconds
Time frame: Approximately 12 months
Change in Left Ventricular Ejection Fraction (LVEF)
Time frame: Baseline, 12 months
Number of Subjects Who Die in One Year
Time frame: Approximately 12 months

Results and safety

Results posted to the registry on 23 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CRT-On First, Then CRT-Off	38	28
CRT-Off First, Then CRT-On	38	37

Primary outcome: Change in Left Ventricle End-Systolic Volume Index (LVESVI)

Time frame: baseline, 12 months. Mean (Standard Deviation). Unit: mL/m^2

Measure	CRT-ON n = 72	CRT-OFF n = 66
Value	-11.6 (12.8)	-4.1 (12.2)

CRT-ON: p = 0.0001, t-test, 2 sided
CRT-OFF: p = 0.009, t-test, 2 sided

Primary outcome: Number of Subjects Experiencing Any System-Related Complications

Time frame: Approximately 12 months. Count of participants. Unit: Participants

Measure	CRT-ON n = 72	CRT-OFF n = 66
Value	2	2

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected on all participants from enrollment through the 48 month follow up visit, for a total of approximately 5 years.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CRT-ON	6 of 76 (7.9%)	44 of 76 (57.9%)	2 of 76
CRT-OFF	8 of 76 (10.5%)	29 of 76 (38.2%)	3 of 76

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Heart Failure

RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Active, not recruiting
Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
Chronic Heart Failure, Heart Transplant Recipient
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Not yet recruitingObservational study
Real-world Effectiveness and Safety of Savagen (Sacubitril/Valsartan) in Malaysian HFrEF Patients
Heart Failure With Reduced Ejection Fraction (HFrEF), Heart Failure

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.

Yong-Mei Cha, MD principal investigator

Mayo Clinic

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 pacemaker (CRT-P) in people with Heart Failure, run by Yong-Mei Cha 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 8 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 23 Jan 2025. 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?

Yes. Results are posted in the registry (first posted 23 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Left Ventricle End-Systolic Volume Index (LVESVI) (time frame: baseline, 12 months). 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?

On the ClinicalTrials.gov record for NCT03420833.

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 23 Jan 2025.