Heart FailureRESETNCT00670111
Restoration of Chronotropic Competence in Heart Failure Patients With Normal Ejection Fraction
A study testing Insignia Plus / Ultra (Guidant/Boston Scientific) in people with Heart Failure, run by Boston Scientific Corporation at 5 sites in United States.
Trial summary
This study will look at how pacing your heart may assist your daily activities and how you are feeling. 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?
- Insignia Plus / Ultra (Guidant/Boston Scientific)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 5 sitesUnited States
- Study dates
- Jul 2008to Jul 2011
- 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
- Patients who are in sinus rhythm
- Patients who are on stable medical therapy
- Patients who exhibit signs and symptoms of heart failure, New York Heart Association (NYHA) Class II or III
- Patients who have experienced a hospitalization for decompensated heart failure; treatment for pulmonary congestion or volume overload; chronic treatment with a loop diuretic; or a brain natriuretic peptide (BNP) > 125 ng/l.
- Left ventricular ejection fraction (LVEF) ≥ 50%
Who cannot join
- Patients with persistent atrial fibrillation or atrial flutter
- Patients who are in complete heart block
- Patients who have experienced a recent myocardial infarction (MI) or have unstable angina or require cardiac surgery or other procedures
- Patients who have severe heart valve disease or valve replacement
- Patients with a contraindication for a pacemaker system
- Patients who have a neuromuscular, orthopedic or other non-cardiac condition that prevents patient from exercise testing
Show all 9Show fewer
- Patients who have infiltrative or hypertrophic cardiomyopathy
- Patients who have known severe pulmonary disease
- Patients with uncontrolled diabetes or blood pressure (systolic blood pressure (SBP) > 160 mmHg or diastolic blood pressure (DBP) > 95 mmHg)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Johns Hopkins Medical Institutions
Baltimore, Maryland, 21205
Cardiovascular Associates of Northeast Arkansas
Jonesboro, Arkansas, 72401
Cardiovascular Associates
Louisville, Kentucky, 40205
Mayo Clinic Foundation
Rochester, Minnesota, 55902
Tyler CV Consultants - Trinity Mother Frances
Tyler, Texas, 75701
About this study
This study will look at how pacing your heart may assist your daily activities and how you are feeling.
Read the detailed description
RESET is a multicenter trial that will assess the effect of pacing in heart failure patients with a normal ejection fraction (or diastolic heart failure). The purpose of the RESET study is to evaluate the effect of pacing on exercise capacity and quality of life in this heart failure population.
- Conditions
- Heart Failure
- Being tested
- Insignia Plus / Ultra (Guidant/Boston Scientific)
- Keywords
- Heart failure, exercise capacity, ejection fraction, Heart failure normal ejection fraction
- Medical subject headings
- Heart Failure, Heart Failure, Diastolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insignia Plus / Ultra (Guidant/Boston Scientific)Device
Also called Guidant or Boston Scientific implantable pacemakers
Cardiac pacing using any Guidant/Boston Scientific Implantable Pacemaker System with rate-modulation and any compatible intracardiac lead system.
| Study group | Role | What they receive |
|---|---|---|
| RAP On then Off at 1 month visit | Experimental | 1. Rate Adaptive Pacing (RAP) On for first cardiopulmonary exercise test (CPX) at one month.
2. Rate Adaptive Pacing (RAP) Off for second cardiopulmonary exercise test (CPX) at one month. Receives: Device: Insignia Plus / Ultra (Guidant/Boston Scientific) |
| RAP Off then On at 1 month visit | Experimental | 1. Rate Adaptive Pacing (RAP) Off for first cardiopulmonary exercise test (CPX) at one month.
2. Rate Adaptive Pacing (RAP) On for second cardiopulmonary exercise test (CPX) at one month. Receives: Device: Insignia Plus / Ultra (Guidant/Boston Scientific) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Volume of Oxygen Uptake (Peak VO2) - Rate Adaptive Pacing (RAP) On at One Month vs. Rate Adaptive Pacing (RAP) Off at One Month.
Randomized therapy order cross-over comparison at 1 month post-implant. Each patient evaluated for endpoint with and without RAP therapy at this time.
Measured: 1 month post implant
Secondary outcomes (1)
Peak Volume of Oxygen Uptake (Peak VO2) - Rate Adaptive Pacing (RAP) On at Six Months vs. Rate Adaptive Pacing (RAP) Off at One Month.
Each patient had RAP therapy On from one through six months. This endpoint evaluated Peak VO2 measured at 6 months (RAP On) vs. Peak VO2 measured at 1 month without RAP therapy (RAP Off).All participants were "RAP On" for months 1 through 6. All participants were 'Rap On' for months 6 to 12.
Measured: 6 months post implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2008 (estimated)
- Study startJul 2008
- Primary completionJul 2011
- Study completionJul 2011
Why it stopped: Difficulty in enrollment
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David A Kass, M.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00670111
- Sponsor's protocol ID
- RESET
- Acronym
- RESET
- Status last verified
- May 2017
- First submitted
- 23 Apr 2008
- Last updated
- 19 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Kass DA, Kitzman DW, Alvarez GE. The restoration of chronotropic competence in heart failure patients with normal ejection fraction (RESET) study: rationale and design. J Card Fail. 2010 Jan;16(1):17-24. doi: 10.1016/j.cardfail.2009.08.008. Epub 2009 Oct 7.
PubMed 20123314
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoration of Chronotropic Competence in Heart Failure Patients With Normal Ejection Fraction
- ClinicalTrials.gov ID
- NCT00670111
- Acronym / sponsor ID
- RESET / RESET
- Conditions
- Heart Failure
- Keywords
- Heart failure, exercise capacity, ejection fraction, Heart failure normal ejection fraction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in enrollment
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 1 May 2008 (estimated)
- Results
- Posted 19 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will look at how pacing your heart may assist your daily activities and how you are feeling.
Detailed description
RESET is a multicenter trial that will assess the effect of pacing in heart failure patients with a normal ejection fraction (or diastolic heart failure). The purpose of the RESET study is to evaluate the effect of pacing on exercise capacity and quality of life in this heart failure population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RAP On then Off at 1 month visit | Experimental | Device: Insignia Plus / Ultra (Guidant/Boston Scientific)1. Rate Adaptive Pacing (RAP) On for first cardiopulmonary exercise test (CPX) at one month. 2. Rate Adaptive Pacing (RAP) Off for second cardiopulmonary exercise test (CPX) at one month. |
| RAP Off then On at 1 month visit | Experimental | Device: Insignia Plus / Ultra (Guidant/Boston Scientific)1. Rate Adaptive Pacing (RAP) Off for first cardiopulmonary exercise test (CPX) at one month. 2. Rate Adaptive Pacing (RAP) On for second cardiopulmonary exercise test (CPX) at one month. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who are in sinus rhythm
- Patients who are on stable medical therapy
- Patients who exhibit signs and symptoms of heart failure, New York Heart Association (NYHA) Class II or III
- Patients who have experienced a hospitalization for decompensated heart failure; treatment for pulmonary congestion or volume overload; chronic treatment with a loop diuretic; or a brain natriuretic peptide (BNP) > 125 ng/l.
- Left ventricular ejection fraction (LVEF) ≥ 50%
Key exclusion criteria (9 listed)
- Patients with persistent atrial fibrillation or atrial flutter
- Patients who are in complete heart block
- Patients who have experienced a recent myocardial infarction (MI) or have unstable angina or require cardiac surgery or other procedures
- Patients who have severe heart valve disease or valve replacement
- Patients with a contraindication for a 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 |
|---|---|---|
| Insignia Plus / Ultra (Guidant/Boston Scientific)Also: Guidant or Boston Scientific implantable pacemakersCardiac pacing using any Guidant/Boston Scientific Implantable Pacemaker System with rate-modulation and any compatible intracardiac lead system. | Device | RAP Off then On at 1 month visit, RAP On then Off at 1 month visit |
Primary outcome
Peak Volume of Oxygen Uptake (Peak VO2) - Rate Adaptive Pacing (RAP) On at One Month vs. Rate Adaptive Pacing (RAP) Off at One Month.
Time frame: 1 month post implant
Randomized therapy order cross-over comparison at 1 month post-implant. Each patient evaluated for endpoint with and without RAP therapy at this time.
1 secondary outcome
Peak Volume of Oxygen Uptake (Peak VO2) - Rate Adaptive Pacing (RAP) On at Six Months vs. Rate Adaptive Pacing (RAP) Off at One Month.
Time frame: 6 months post implant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20123314Kass DA, Kitzman DW, Alvarez GE. The restoration of chronotropic competence in heart failure patients with normal ejection fraction (RESET) study: rationale and design. J Card Fail. 2010 Jan;16(1):17-24. doi: 10.1016/j.cardfail.2009.08.008. Epub 2009 Oct 7.
- 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.
David A Kass, M.D. principal investigator
Johns Hopkins University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insignia Plus / Ultra (Guidant/Boston Scientific) in people with Heart Failure, run by Boston Scientific Corporation at 5 sites 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 5 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: stopped early, as of the sponsor's last update on 19 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 19 May 2017). 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?
Peak Volume of Oxygen Uptake (Peak VO2) - Rate Adaptive Pacing (RAP) On at One Month vs. Rate Adaptive Pacing (RAP) Off at One Month. (time frame: 1 month post implant). 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 NCT00670111, 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 19 May 2017.