Clinical trial NCT02358603: Chronotropic Incompetence (CI) Diagnostic Algorithm in Heart Failure Patients
Official title: Investigation of the Chronotropic Incompetence Diagnostic Algorithm in Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure
Keywords: Chronotropic Incompetence
Heart Failure
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2015-02-09
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility 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.

Primary outcomes:
measure: Chronotropic Incompetence Index of Patients With Heart Failure Disease
timeFrame: Implant through 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital Luwan Branch, Shanghai JiaoTong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Sixth People's Hospital Affiliated to Shanghai Jiaotong University
state: Shanghai
Study officials:
affiliation: Ruijin Hospital Luwan Branch, Shanghai JiaoTong University School of Medicine
name: Jianrong Zhao, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sixth People's Hospital Affiliated to Shanghai Jiaotong University
name: Jinbo Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.