Heart FailureNCT02783716
Vascular Endothelial Function and Cardiac Resynchronization Response in Patients With Heart Failure
A study testing Subcutaneous adipose tissue collection and Peripheral arterial tonometry (PAT) in people with Heart Failure, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research study is to determine the role of blood vessel endothelial function in heart failure and the effect of Cardiac Resynchronization Therapy (CRT) on heart and endothelial function. 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?
- Subcutaneous adipose tissue collection and Peripheral arterial tonometry (PAT)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to 20 Jul 2021
- 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 Group: Patients recommended for CRT-P or CRT-D for heart failure (HF) according to current American Heart Association (AHA)/American College of Cardiology (ACC)/Heart Rhythm Society (HRS) guidelines of Left Ventricle Ejection Fraction (LVEF)<35%, Left Bundle Branch Block (LBBB)>120 ms, New York Heart Association (NYHA) Class II-III).
- Control Group: Patients who undergo device (pacemaker or ICD) implantation or a pack change for sinus node dysfunction or AV blocks
Who cannot join
- Patients who are unwilling or unable to return for follow up visits 3 months after device implantation.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research study is to determine the role of blood vessel endothelial function in heart failure and the effect of Cardiac Resynchronization Therapy (CRT) on heart and endothelial function.
- Conditions
- Heart Failure
- Being tested
- Subcutaneous adipose tissue collection, Peripheral arterial tonometry (PAT)
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous adipose tissue collectionProcedure or surgery
During standard of care device implantation procedure, a small piece of fat tissue will be removed from the device pocket inside the chest
Peripheral arterial tonometry (PAT)Diagnostic test
Also called EndoPAT
Non-invasive testing for blood vessel function. Specially designed finger probes placed on the middle finger of each hand. Pulsatile volume changes of the distal digit inducing pressure alterations in the finger cuff will be sensed by pressure transducers and recorded. Endothelial function will be measured via a reactive hyperemia (RH)-PAT index (RHI)
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Resynchronization Therapy (CRT) Group | Active comparator | Participants undergoing Cardiac Resynchronization Therapy Implantation (CRT) implantation for heart failure as part of standard of care will receive EndoPAT testing and collection of subcutaneous adipose tissue Receives: Procedure: Subcutaneous adipose tissue collection; Diagnostic Test: Peripheral arterial tonometry (PAT) |
| Control Group | Active comparator | Participants undergoing device pacemaker or implantable cardioverter-defibrillator (ICD) implantation or pack change for sinus node dysfunction or Atrioventricular (AV) block as part of standard of care will receive EndoPAT testing and collection of subcutaneous adipose tissue Receives: Procedure: Subcutaneous adipose tissue collection; Diagnostic Test: Peripheral arterial tonometry (PAT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vascular endothelial function
Vascular endothelial function will be measured using peripheral arterial tonometry as the reactive hyperemia index (RHI) at baseline and at 3 months.
Measured: baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2016 (estimated)
- Study startMay 2016
- Primary completion20 Jul 2021
- Study completion20 Jul 2021
Why it stopped: Due to COVID and staffing issues study was terminated
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.
- More trials run by Mayo ClinicThe 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hon-Chi Lee, M.D., Ph.D., Mayo Clinic
- Investigators
- Hon-Chi Lee, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02783716
- Sponsor's protocol ID
- 15-006402
- Status last verified
- Jan 2023
- First submitted
- 20 May 2016
- Last updated
- 18 Jan 2023
- 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 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Endothelial Function and Cardiac Resynchronization Response in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT02783716
- Acronym / sponsor ID
- 15-006402
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to COVID and staffing issues study was terminated
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- 20 Jul 2021 (actual)
- Study completion
- 20 Jul 2021 (actual)
- First posted
- 26 May 2016 (estimated)
- 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 purpose of this research study is to determine the role of blood vessel endothelial function in heart failure and the effect of Cardiac Resynchronization Therapy (CRT) on heart and endothelial function.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiac Resynchronization Therapy (CRT) Group | Active comparator | Procedure: Subcutaneous adipose tissue collection, Diagnostic Test: Peripheral arterial tonometry (PAT)Participants undergoing Cardiac Resynchronization Therapy Implantation (CRT) implantation for heart failure as part of standard of care will receive EndoPAT testing and collection of subcutaneous adipose tissue |
| Control Group | Active comparator | Procedure: Subcutaneous adipose tissue collection, Diagnostic Test: Peripheral arterial tonometry (PAT)Participants undergoing device pacemaker or implantable cardioverter-defibrillator (ICD) implantation or pack change for sinus node dysfunction or Atrioventricular (AV) block as part of standard of care will receive EndoPAT testing and collection of subcutaneous adipose tissue |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- CRT Group: Patients recommended for CRT-P or CRT-D for heart failure (HF) according to current American Heart Association (AHA)/American College of Cardiology (ACC)/Heart Rhythm Society (HRS) guidelines of Left Ventricle Ejection Fraction (LVEF)<35%, Left Bundle Branch Block (LBBB)>120 ms, New York Heart Association (NYHA) Class II-III).
- Control Group: Patients who undergo device (pacemaker or ICD) implantation or a pack change for sinus node dysfunction or AV blocks
Key exclusion criteria (1 listed)
- Patients who are unwilling or unable to return for follow up visits 3 months after device implantation.
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 |
|---|---|---|
| Subcutaneous adipose tissue collectionDuring standard of care device implantation procedure, a small piece of fat tissue will be removed from the device pocket inside the chest | Procedure or surgery | Cardiac Resynchronization Therapy (CRT) Group, Control Group |
| Peripheral arterial tonometry (PAT)Also: EndoPATNon-invasive testing for blood vessel function. Specially designed finger probes placed on the middle finger of each hand. Pulsatile volume changes of the distal digit inducing pressure alterations in the finger cuff will be sensed by pressure transducers and recorded. Endothelial function will be measured via a reactive hyperemia (RH)-PAT index (RHI) | Diagnostic test | Cardiac Resynchronization Therapy (CRT) Group, Control Group |
Primary outcome
Change in vascular endothelial function
Time frame: baseline, 3 months
Vascular endothelial function will be measured using peripheral arterial tonometry as the reactive hyperemia index (RHI) at baseline and at 3 months.
Results and safety
The study was stopped early (reason given: Due to COVID and staffing issues study was terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Hon-Chi Lee, MD, PhD 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 Subcutaneous adipose tissue collection and Peripheral arterial tonometry (PAT) in people with Heart Failure, run by Mayo Clinic 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 2 inclusion and 1 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: stopped early, as of the sponsor's last update on 18 Jan 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. 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 was stopped early (reason given: Due to COVID and staffing issues study was terminated). Results are not available in the source record.
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 vascular endothelial function (time frame: baseline, 3 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 18 Jan 2023.