Heart FailurePhase 4NCT01016431
Effects of Atrial Rate-adaptive Pacing on Exercise Capacity in Patients With Chronic Heart Failure Complicated by Chronotropic Incompetence
A Phase 4 study testing Rate-adaptive pacemaker programming and VVI at 40 bpm in people with Heart Failure and Exercise Tolerance, run by Federico II University at 1 site in Italy.
Trial summary
Chronotropic incompetence consists of an insufficient increase in heart rate during effort, and its presence is recognized as a common feature in patients with heart failure due to left ventricular systolic dysfunction, apparently suggesting a worse prognosis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Failure, Exercise Tolerance
- What is being tested?
- Rate-adaptive pacemaker programming and VVI at 40 bpm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2009to Aug 2012
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- NYHA II/III chronic heart failure on optimal medical therapy
- Sinus Rhythm
- Left ventricular ejection fraction less than 40 %
- Chronotropic incompetence on maximal exercise testing (maximum heart rate < 80% of predicted value)
- Age 18-75
- carrier of dual chamber ICD device
- Informed Consent
Who cannot join
- Unable to perform cardiopulmonary exercise testing (for any reason)
- Absolute contraindication to maximal exercise testing
- Moderate to severe anemia (Hb<10 g/dL)
- Diagnosis of Sick Sinus Syndrome or high-degree atrioventricular block
- recent hospitalization for acute decompensated heart failure (<1 month)
- recent acute coronary syndrome (<3 months)
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- Active neoplastic disease
- Active myocarditis / endocarditis
- Acute decompensated heart failure during study
Trial locations and contacts
1 site in 1 country.
Guido Carlomagno, MD contact
Italy1 site, 1 recruiting
- Recruiting
Federico II University - Department of Internal Medicine
Naples, 80100
About this study
Chronotropic incompetence consists of an insufficient increase in heart rate during effort, and its presence is recognized as a common feature in patients with heart failure due to left ventricular systolic dysfunction, apparently suggesting a worse prognosis. Little is known about the possible benefits of its reversal in such patients.
The investigators working hypothesis is that the modulation of chronotropic response, as obtained by means of atrial rate-adaptive pacing may improve functional capacity in persons with chronic heart failure and chronotropic incompetence.
Read more
To explore this hypothesis,the investigators will enroll 20 patients with NYHA II/III heart failure, low left ventricular ejection fraction (<40%) and chronotropic incompetence (Maximal heart rate <80% of predicted value in a symptom-limited incremental test), who already underwent implantation of dual-chamber implantable defibrillator for prevention of sudden cardiac death. The study will have a randomized, double-blind, cross-over design.
The procedures, to be carried out at one month from each reprogramming (VVI backup pacing vs. AAI-R "active" pacing), will comprise: blood sampling for NT-proBNP, incremental symptom-limited cardiopulmonary exercise testing (CPX), constant-workload cardiopulmonary test (50% of max WR), quality-of-life questionnaire, 24-hour ECG monitoring.
The primary end-point will be peak oxygen consumption on CPX. Secondary end-points will include acute response to reprogramming, and data derived from constant-WR tests, Holter monitoring and QoL.
- Conditions
- Heart Failure, Exercise Tolerance
- Being tested
- Rate-adaptive pacemaker programming, VVI at 40 bpm
- Keywords
- cardiac pacing, heart failure, oxygen consumption, ventricular dysfunction, left, exercise tolerance, chronotropic incompetence, pacemaker programming
- Medical subject headings
- Heart Failure, Ventricular Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rate-adaptive pacemaker programmingOther
The ICD will be programmed in a AAI-R mode, with peak atrial stimulation rate set at 85% of maximal predicted heart rate, and ongoing protection VVI backup at 40 bpm
VVI at 40 bpmOther
ICDs will be programmed in VVI mode at 40 bpm
| Study group | Role | What they receive |
|---|---|---|
| Rate adaptive | Experimental | Patients will have their ICD programmed in a AAI-R mode, with peak atrial rate set at 85% of age-adjusted predicted maximal HR Receives: Other: Rate-adaptive pacemaker programming |
| Control | Active comparator | ICDs will be programmed in the usual VVI backup pacing mode at 40 bpm Receives: Other: VVI at 40 bpm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Oxygen consumption on cardiopulmonary exercise testing
Measured: 1 month
Secondary outcomes (5)
Peak Heart Rate on Cardiopulmonary exercise testing
Measured: 1 month
Quality of life as assessed by Minnesota Living with Heart Failure and SF-36 Questionnaires
Measured: 1 month
Heart Rate Variability on Holter Monitoring
Measured: 1 month
Acute Change in Peak Oxygen Consumption after reprogrammation
Measured: 1 hour
NT-proBNP levels
Measured: 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionJul 2012 (estimated)
- Study completionAug 2012 (estimated)
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 Federico II UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01016431
- Sponsor's protocol ID
- CHRON-INC-09
- Status last verified
- Nov 2009
- First submitted
- 18 Nov 2009
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Atrial Rate-adaptive Pacing on Exercise Capacity in Patients With Chronic Heart Failure Complicated by Chronotropic Incompetence
- ClinicalTrials.gov ID
- NCT01016431
- Acronym / sponsor ID
- CHRON-INC-09
- Conditions
- Heart Failure, Exercise Tolerance
- Keywords
- cardiac pacing, heart failure, oxygen consumption, ventricular dysfunction, left, exercise tolerance, chronotropic incompetence, pacemaker programming
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 19 Nov 2009 (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.
Chronotropic incompetence consists of an insufficient increase in heart rate during effort, and its presence is recognized as a common feature in patients with heart failure due to left ventricular systolic dysfunction, apparently suggesting a worse prognosis. Little is known about the possible benefits of its reversal in such patients.
The investigators working hypothesis is that the modulation of chronotropic response, as obtained by means of atrial rate-adaptive pacing may improve functional capacity in persons with chronic heart failure and chronotropic incompetence.
To explore this hypothesis,the investigators will enroll 20 patients with NYHA II/III heart failure, low left ventricular ejection fraction (<40%) and chronotropic incompetence (Maximal heart rate <80% of predicted value in a symptom-limited incremental test), who already underwent implantation of dual-chamber implantable defibrillator for prevention of sudden cardiac death. The study will have a randomized, double-blind, cross-over design.
The procedures, to be carried out at one month from each reprogramming (VVI backup pacing vs. AAI-R "active" pacing), will comprise: blood sampling for NT-proBNP, incremental symptom-limited cardiopulmonary exercise testing (CPX), constant-workload cardiopulmonary test (50% of max WR), quality-of-life questionnaire, 24-hour ECG monitoring.
The primary end-point will be peak oxygen consumption on CPX. Secondary end-points will include acute response to reprogramming, and data derived from constant-WR tests, Holter monitoring and QoL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rate adaptive | Experimental | Other: Rate-adaptive pacemaker programmingPatients will have their ICD programmed in a AAI-R mode, with peak atrial rate set at 85% of age-adjusted predicted maximal HR |
| Control | Active comparator | Other: VVI at 40 bpmICDs will be programmed in the usual VVI backup pacing mode at 40 bpm |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- NYHA II/III chronic heart failure on optimal medical therapy
- Sinus Rhythm
- Left ventricular ejection fraction less than 40 %
- Chronotropic incompetence on maximal exercise testing (maximum heart rate < 80% of predicted value)
- Age 18-75
Key exclusion criteria (9 listed)
- Unable to perform cardiopulmonary exercise testing (for any reason)
- Absolute contraindication to maximal exercise testing
- Moderate to severe anemia (Hb<10 g/dL)
- Diagnosis of Sick Sinus Syndrome or high-degree atrioventricular block
- recent hospitalization for acute decompensated heart failure (<1 month)
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 |
|---|---|---|
| Rate-adaptive pacemaker programmingThe ICD will be programmed in a AAI-R mode, with peak atrial stimulation rate set at 85% of maximal predicted heart rate, and ongoing protection VVI backup at 40 bpm | Other | Rate adaptive |
| VVI at 40 bpmICDs will be programmed in VVI mode at 40 bpm | Other | Control |
Primary outcome
Peak Oxygen consumption on cardiopulmonary exercise testing
Time frame: 1 month
5 secondary outcomes
Peak Heart Rate on Cardiopulmonary exercise testing
Time frame: 1 month
Quality of life as assessed by Minnesota Living with Heart Failure and SF-36 Questionnaires
Time frame: 1 month
Heart Rate Variability on Holter Monitoring
Time frame: 1 month
Acute Change in Peak Oxygen Consumption after reprogrammation
Time frame: 1 hour
NT-proBNP levels
Time frame: 1 Month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2011.
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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.
Guido Carlomagno, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rate-adaptive pacemaker programming and VVI at 40 bpm in people with Heart Failure and Exercise Tolerance, run by Federico II University at 1 site in Italy.
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 7 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: status not confirmed, as of the sponsor's last update on 27 Jun 2011. 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 Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Serafino Fazio, MD (+390817463737, fazio@unina.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Oxygen consumption on cardiopulmonary exercise testing (time frame: 1 month). 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 27 Jun 2011.