Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Assessment of AAIR Pacing Treatment for Heart Failure Patients With Chronotropic Incompetence

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: NCT03071952
Recruitment Status : Completed
First Posted : March 7, 2017
Last Update Posted : January 11, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Brief Summary:
The primary objective of this study is to assess the clinical efficacy of AAIR (Atrial-paced Atrial-sensed Inhibitory Rate-Modulated) pacing treatment for heart failure (HF) patients with chronotropic incompetence (CI) in terms of exercise tolerance and quality of life. Specifically, the study will assess the changes in cardiac function associated with changes of physical exercise intensity and heart rate in AAIR pacing mode compared with AAI pacing mode.

Condition or disease
Heart Failure

Detailed Description:

CI is the inability of the heart to increase its rate in response to increased physical activity or metabolic demand, leading to exercise intolerance and poor quality of life. Studies have demonstrated that patients with CI have a high risk of cardiac morbidity and mortality. Recent studies further demonstrate a high incidence of CI in patients with heart failure, which is also confirmed by CI in Heart Failure Study Phase I. However, clinical attention is often paid to heart failure symptoms instead CI-related symptom. Thus, patients with heart failure are often not tested for CI, even though the CI incidence is high in these patients. Moreover, such patients could gain significant improvements in exercise tolerance and quality of life once they get diagnosed followed by effective therapy for CI and long-term management.

This study is designed to establish clinical evidence that AAIR pacing is beneficial to treat CI-caused symptoms in heart failure patients, which will improve the life quality of such patients and further support the expansion of Brady therapy indications to the population of HF with CI in existing markets and also potential markets.

CI is rarely seen and has different definition among various animal species. It is impossible to use animals to get wanted data for AAIR pacing treatment to CI. Thus, a human clinical study is necessary. Furthermore, exercise testings, such as 6 minutes hall walk (6MHW) and treadmill, allow objective evaluation of exercise capacity and exertional symptoms, which have been suggested as other investigations for HF in "ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012". Therefore, exercise testings will be applied upon physicians' need or judgment.

Firstly, this study is to assess the effect of AAIR pacing treatment for HF patients with CI in terms of exercise tolerance and quality of life. Specifically, the study will assess the changes in cardiac function associated with changes of physical exercise intensity and heart rate in AAIR pacing mode compared with AAI pacing mode. Secondly, the study will look at clinical outcomes in terms of NYHA class, 6MHW, blood BNP, Echo measurements following pacemaker therapy for 1 year. 6MHW and treadmill tests have been suggested as other investigations for HF in "ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012" and will be performed upon physicians' need or judgment.

The study will enroll up to 30 subjects that meet the indication for pacing therapy. Consented subjects will receive pacing therapy and two follow-ups in the following one year.

Layout table for study information
Study Type : Observational
Actual Enrollment : 11 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Assessment of AAIR Pacing Treatment for Heart Failure Patients With Chronotropic Incompetence
Actual Study Start Date : October 9, 2016
Actual Primary Completion Date : November 24, 2017
Actual Study Completion Date : November 24, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure




Primary Outcome Measures :
  1. The treadmill walk duration change [ Time Frame: The treadmill walk duration change from 3-6 months to 6-12 months post pacemaker implantation ]

Secondary Outcome Measures :
  1. The 6 minutes hall walk distance change [ Time Frame: 3-6 months and 6-12 months post pacemaker implantation ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
In the study, total 30 heart failure patients with chronotropic incompetence who meet the inclusion and exclusion criteria would be enrolled from the ourtpatients in Fuwai Hospital.
Criteria

Inclusion Criteria:

  • Patient is willing to give informed consent.
  • Patient is between 18 and 70 years of age (including 18 and 70 years of age).
  • Patients can perform treadmill exercise test for at least 8 minutes.
  • Patient has been diagnosed with stable chronic HF according to HF guidance, including HFpEF (Heart Failure with preserved Ejection Fraction) and HFrEF (Heart Failure with reduced Ejection Fraction) patients.
  • NYHA class I- III, with left ventricular ejection fraction less than 55% and more than 25%.
  • Heart rate during treadmill test cannot reach 70% APMHR (Age Predicted Maximal Heart Rate) in (diagnostic criteria for CI, in accordance with class IA indications of pacing therapy for CI).

Exclusion Criteria:

  • Patient with severe liver or kidney dysfunction.
  • Patient has contraindications for pacing therapy.
  • Patient has CI and is under appropriate clinical therapy.
  • Patient has persistent or permanent atrial fibrillation (AF).
  • Patient whose heart rate baseline at resting state 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, hypertrophic cardiomyopathy, valvular heart disease and ECG ST-segment shift > 2mm at resting state.
  • Less than 6 months after angina and ST dynamic changes during last 3 months.
  • Patient with class I (with PR interval more than 200ms), II or III atrioventricular block, or interventricular block.
  • NYHA Class IV.
  • Less than 45 days after myocardial infarction.
  • Less than 3 months after acute heart failure.
  • Patient has uncontrolled hypertension.
  • Patient is unwilling to sign the patient informed consent.
  • Patient is pregnant or has pregnancy intention in the study duration.
  • 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): NCT03071952


Locations
Layout table for location information
China, Beijing
Fuwai Hospital
Beijing, Beijing, China, 100037
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
Layout table for investigator information
Principal Investigator: Shu Zhang, PhD Fuwai Hospital
Layout table for additonal information
Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT03071952    
Other Study ID Numbers: CI Study Phase II
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:
Heart Failure
Chronotropic Incompetence
Rate Response
Exercise Test
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases