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Chronotropic Incompetence (CI) Diagnostic Algorithm in Heart Failure Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02358603
Recruitment Status : Terminated (Low recruitment rate)
First Posted : February 9, 2015
Results First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Brief 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.

Condition or disease Intervention/treatment Phase
Heart Failure Diagnostic Test: Chronotropic Incompetence Diagnostic Algorithm Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Diagnostic
Official Title: Investigation of the Chronotropic Incompetence Diagnostic Algorithm in Heart Failure Patients
Actual Study Start Date : June 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Case group
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.
Diagnostic Test: Chronotropic Incompetence Diagnostic Algorithm
Other Name: Standard of Care Diagnostic Testing

Placebo Comparator: Control group
Each subject of the control group will do the same test and examination with the subjects in the case group.
Diagnostic Test: Chronotropic Incompetence Diagnostic Algorithm
Other Name: Standard of Care Diagnostic Testing




Primary Outcome Measures :
  1. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria for the case group:

  • 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%.

Inclusion criteria for the control group:

  • Subject is greater than 18 years of age and less than 70 years of old.
  • Subject is willing and able to give informed consent.

Exclusion criteria for the case group:

  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02358603


Locations
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China, Shanghai
Ruijin Hospital Luwan Branch, Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai, China, 200020
Sixth People's Hospital Affiliated to Shanghai Jiaotong University
Shanghai, Shanghai, China, 200233
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
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Principal Investigator: Jianrong Zhao, MD Ruijin Hospital Luwan Branch, Shanghai JiaoTong University School of Medicine
Principal Investigator: Jinbo Li, MD Sixth People's Hospital Affiliated to Shanghai Jiaotong University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT02358603    
Other Study ID Numbers: CI in Heart Failure Study
First Posted: February 9, 2015    Key Record Dates
Results First Posted: February 5, 2020
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:
Chronotropic Incompetence
Heart Failure
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases