Chronotropic Incompetence (CI) Diagnostic Algorithm in Heart Failure Patients

NCT02358603 | Terminated Results

• 1 other identifier: CI in Heart Failure Study
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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.

Conditions

Heart Failure

Keywords

Chronotropic Incompetence; Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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.

  Implant through 6 months

Study Arms (2)

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.

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.

Diagnostic Test: Chronotropic Incompetence Diagnostic Algorithm

Interventions

Chronotropic Incompetence Diagnostic Algorithm DIAGNOSTIC_TEST

Also known as: Standard of Care Diagnostic Testing

Case group; Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (2)

Ruijin Hospital Luwan Branch, Shanghai JiaoTong University School of Medicine

Shanghai, Shanghai Municipality, 200020, China

Location

Sixth People's Hospital Affiliated to Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200233, China

Location

Related Publications (1)

• 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.

  PMID: 28545575 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Limitations and Caveats

Because the study was discontinued, none of objectives of the study were met, the pre-specified analyses for all objectives were not performed (per study protocol).

Results Point of Contact

• Title: Dr. Zhao, Jianrong
• Organization: Department of Cardiology, Ruijin Hospital Luwan Branch, Shanghai Jiao Tong University School of Medicine

drzjr@126.com

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 16, 2014
• First Posted: February 9, 2015
• Study Start: June 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 5, 2020
• Results First Posted: February 5, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)