Heart FailureNCT02358603
Chronotropic Incompetence (CI) Diagnostic Algorithm in Heart Failure Patients
A study testing Chronotropic Incompetence Diagnostic Algorithm in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 2 sites in China.
Trial summary
This study is to collect human activity and electrocardiogram (ECG) data from heart failure (HF) patients to aid in the development of a novel chronotropic incompetence (CI) algorithm designed to diagnose CI in patients with HF. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Chronotropic Incompetence Diagnostic Algorithm
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesChina
- Study dates
- Jun 2014to Dec 2015
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is greater than 18 years of age and less than 70 years of old.
- Patient is willing and able to give informed consent.
- Patient has been diagnosed with stable chronic HF according to European Society of Cardiology 2012 HF guidance.
- New York Heart Association class I- III, including with HF with preserved ejection fraction and HF with reduced ejection fraction patients.
- Patients can perform moderate exercise.
- Left ventricular ejection fraction less than 55% but greater than 35%.
- Subject is greater than 18 years of age and less than 70 years of old.
- Subject is willing and able to give informed consent.
Who cannot join
- Patient is unable or unwilling to sign the patient informed consent.
- Patient has implantable pacemaker, Implantable cardiovert defibrillator (ICD) or cardiac resynchronize therapy (CRT) device.
- Patient has at least one pacemaker, ICD or CRT indications.
- Patients has persistent atrial fibrillation (AF).
- Patient whose hear rate baseline at the rest is greater than 95 beats per minutes (BPM).
- Patient has contraindications for cardio-pulmonary exercise testing, including but not limited to, unstable angina, decompensated heart failure, active pericarditis or myocarditis and ECG ST-segment shift > 2mm at the resting.
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- New York Heart Association Class IV.
- Less than 45 days after myocardial infarction.
- Less than 3 months after acute heart failure.
- Patient has uncontrolled hypertension.
- Patient is pregnant.
- Patient has a medical condition that would limit study participation.
- Patient is enrolled in a concurrent study that may affect the outcome of this study.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Ruijin Hospital Luwan Branch, Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality, 200020
Sixth People's Hospital Affiliated to Shanghai Jiaotong University
Shanghai, Shanghai Municipality, 200233
About this study
Official title: Investigation of the Chronotropic Incompetence Diagnostic Algorithm in Heart Failure Patients
This study is to collect human activity and electrocardiogram (ECG) data from heart failure (HF) patients to aid in the development of a novel chronotropic incompetence (CI) algorithm designed to diagnose CI in patients with HF.
Read the detailed description
The Investigation of the Chronotropic Incompetence Diagnostic Algorithm in Heart Failure Patients (CI Algorithm Study) is an acute data collection study using market released actigraphy devices (wGT3X-BT) and holter devices (DR 180) to measure study subjects' daily activities and surface ECG data simultaneously. The data will be analyzed to develop an algorithm to diagnose CI in patients with HF.
- Conditions
- Heart Failure
- Being tested
- Chronotropic Incompetence Diagnostic Algorithm
- Keywords
- Chronotropic Incompetence, Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronotropic Incompetence Diagnostic AlgorithmDiagnostic test
Also called Standard of Care Diagnostic Testing
| Study group | Role | What they receive |
|---|---|---|
| Case group | Experimental | At the beginning of the study, each subject of the case group will complete echo examination and related lab test for BNP. During the study, each subject will have a six minutes' walk test and 24 hour ambulatory monitoring while having an ActiGraph device placed on his/her wrist and a Holter device with ECG electrodes placed on his/her chest. The treadmill test is optional to patients per physicians' instruction and/or patients' own judgment. It would be performed at the end of the study if chosen. Receives: Diagnostic Test: Chronotropic Incompetence Diagnostic Algorithm |
| Control group | Placebo comparator | Each subject of the control group will do the same test and examination with the subjects in the case group. Receives: Diagnostic Test: Chronotropic Incompetence Diagnostic Algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronotropic Incompetence Index of Patients With Heart Failure Disease
Compare chronotropic incompetence index in patients with heart failure using an interventional diagnostic algorithm compared to standard of care diagnostics.
Chronotropic Index = [achieved maximal HR-resting HR]/[age-predicted maximal HR-resting HR]. Normal CI is ~ 1 with low CI considered < 0.8
Measurement described as: Chronotropic index=HRR/metabolic reserve.
Measured: Implant through 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2015 (estimated)
- Study startJun 2014
- Primary completionJun 2015
- Study completionDec 2015
Why it stopped: Low recruitment rate
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.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Case group subjects will complete study required protocol testing while wearing an experimental device, the ActiGraph device placed on his/her wrist and a Holter device with ECG electrodes placed on his/her chest. Results will be compared to a Control Group.
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianrong Zhao, MD, Principal investigator, Ruijin Hospital Luwan Branch, Shanghai JiaoTong University School of MedicineJinbo Li, MD, Principal investigator, Sixth People's Hospital Affiliated to Shanghai Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02358603
- Sponsor's protocol ID
- CI in Heart Failure Study
- Status last verified
- Jan 2020
- First submitted
- 16 May 2014
- Last updated
- 5 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Shen H, Zhao J, Zhou X, Li J, Wan Q, Huang J, Li H, Wu L, Yang S, Wang P. Impaired chronotropic response to physical activities in heart failure patients. BMC Cardiovasc Disord. 2017 May 25;17(1):136. doi: 10.1186/s12872-017-0571-9.
PubMed 28545575
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Chronotropic Incompetence Diagnostic Algorithm in Heart Failure Patients
- ClinicalTrials.gov ID
- NCT02358603
- Acronym / sponsor ID
- CI in Heart Failure Study
- Conditions
- Heart Failure
- Keywords
- Chronotropic Incompetence, Heart Failure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment rate
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Jun 2014 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 9 Feb 2015 (estimated)
- Results
- Posted 5 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to collect human activity and electrocardiogram (ECG) data from heart failure (HF) patients to aid in the development of a novel chronotropic incompetence (CI) algorithm designed to diagnose CI in patients with HF.
Detailed description
The Investigation of the Chronotropic Incompetence Diagnostic Algorithm in Heart Failure Patients (CI Algorithm Study) is an acute data collection study using market released actigraphy devices (wGT3X-BT) and holter devices (DR 180) to measure study subjects' daily activities and surface ECG data simultaneously. The data will be analyzed to develop an algorithm to diagnose CI in patients with HF.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Case group subjects will complete study required protocol testing while wearing an experimental device, the ActiGraph device placed on his/her wrist and a Holter device with ECG electrodes placed on his/her chest. Results will be compared to a Control Group.
| Arm | Type | Receives |
|---|---|---|
| Case group | Experimental | Diagnostic Test: Chronotropic Incompetence Diagnostic AlgorithmAt the beginning of the study, each subject of the case group will complete echo examination and related lab test for BNP. During the study, each subject will have a six minutes' walk test and 24 hour ambulatory monitoring while having an ActiGraph device placed on his/her wrist and a Holter device with ECG electrodes placed on his/her chest. The treadmill test is optional to patients per physicians' instruction and/or patients' own judgment. It would be performed at the end of the study if chosen. |
| Control group | Placebo comparator | Diagnostic Test: Chronotropic Incompetence Diagnostic AlgorithmEach subject of the control group will do the same test and examination with the subjects in the case group. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient is greater than 18 years of age and less than 70 years of old.
- Patient is willing and able to give informed consent.
- Patient has been diagnosed with stable chronic HF according to European Society of Cardiology 2012 HF guidance.
- New York Heart Association class I- III, including with HF with preserved ejection fraction and HF with reduced ejection fraction patients.
- Patients can perform moderate exercise.
Key exclusion criteria (13 listed)
- Patient is unable or unwilling to sign the patient informed consent.
- Patient has implantable pacemaker, Implantable cardiovert defibrillator (ICD) or cardiac resynchronize therapy (CRT) device.
- Patient has at least one pacemaker, ICD or CRT indications.
- Patients has persistent atrial fibrillation (AF).
- Patient whose hear rate baseline at the rest is greater than 95 beats per minutes (BPM).
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 |
|---|---|---|
| Chronotropic Incompetence Diagnostic AlgorithmAlso: Standard of Care Diagnostic Testing | Diagnostic test | Case group, Control group |
Primary outcome
Chronotropic Incompetence Index of Patients With Heart Failure Disease
Time frame: Implant through 6 months
Compare chronotropic incompetence index in patients with heart failure using an interventional diagnostic algorithm compared to standard of care diagnostics. Chronotropic Index = [achieved maximal HR-resting HR]/[age-predicted maximal HR-resting HR]. Normal CI is ~ 1 with low CI considered < 0.8 Measurement described as: Chronotropic index=HRR/metabolic reserve.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28545575Shen H, Zhao J, Zhou X, Li J, Wan Q, Huang J, Li H, Wu L, Yang S, Wang P. Impaired chronotropic response to physical activities in heart failure patients. BMC Cardiovasc Disord. 2017 May 25;17(1):136. doi: 10.1186/s12872-017-0571-9.
- 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.
Jianrong Zhao, MD principal investigator
Ruijin Hospital Luwan Branch, Shanghai JiaoTong University School of Medicine
Jinbo Li, MD principal investigator
Sixth People's Hospital Affiliated to Shanghai Jiaotong University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chronotropic Incompetence Diagnostic Algorithm in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 2 sites in China.
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 13 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 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
Yes. Results are posted in the registry (first posted 5 Feb 2020). 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?
Chronotropic Incompetence Index of Patients With Heart Failure Disease (time frame: Implant through 6 months). 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 NCT02358603, 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 5 Feb 2020; AzTrials last refreshed its copy on 30 Oct 2026.