Rate Adaptive Atrial Pacing in Heart Failure

NCT03235843 | Unknown DMC

• 1 other identifier: ISROTH20232
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

The ADAPTION trial is an investigator initiated prospective randomized doubleblind cross-over pilot study in a multi-center setting. Aim: to assess the ability of minute ventilation (MV) sensor driven rate adaptive atrial stimulation to restore functional capacity and quality of life in heart failure patients with chronotropic incompetence. Methods: heart failure patients (left ventricular ejection fraction ≤35% \& New York Heart Assessment II or III) who were implanted with a 2-chamber implantable cardioverter defibrillator (ICD) device equipped with a MV sensor that are diagnosed with chronotropic incompetence will be included in the study. Patients will be randomized in a 1:1 fashion to rate responsive pacing (MV sensor only) function ON (AAIR mode) or OFF (DDI mode). After 3 months the pacing mode will be switched to the opposite mode.

Conditions

Chronotropic Incompetence; Heart Failure; ICD

Keywords

Chronotropic Incompetence; Rate Adaptive Pacing; Minute Ventilation Sensor; Primary Prevention ICD Therapy; Implantable Cardioverter Defibrillator; Heart Failure; Exercise Intolerance

Outcome Measures

Primary Outcomes (1)

• Improvement of quality of life

  Measured with the Minnesota Living with Heart Failure Questionnaire

  3 months after changing the pacing mode

Secondary Outcomes (4)

• Improvement of functional capacity

  3 months after changing the pacing mode

• Reversibility of chronotropic incompetence

  3 months after changing the pacing mode

• Clinical status

  3 months after changing the pacing mode

• Daily activity level

  3 months after changing the pacing mode

Study Arms (2)

Rate Adaptive Pacing ON

ACTIVE COMPARATOR

AAIR pacing using a MV sensor

Device: AAIR pacing

Rate Adaptive Pacing OFF

PLACEBO COMPARATOR

DDI-pacing

Device: DDI-pacing

Interventions

AAIR pacing DEVICE

Rate adaptive pacing using a MV sensor.

Rate Adaptive Pacing ON

DDI-pacing DEVICE

Rate adaptive pacing OFF

Rate Adaptive Pacing OFF

Eligibility Criteria

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

You may qualify if:

• Chronotropic incompetence as assessed by a modified Heart Rate Score (mHRS)
• Implanted with a Boston Scientific dual chamber ICD equipped with minute ventilation sensor
• Symptomatic congestive heart failure (NYHA class II-III)
• Left ventricular systolic dysfunction (LVEF \<35%)
• Optimal medical therapy
• Sinus rhythm
• Subjects should be able to perform normal daily activities

You may not qualify if:

• Age \<18 or incapacitated adult
• Indication for pacing (SSS, AV conduction abnormalities requiring pacing)
• Respiratory rate abnormalities (hyperventilation) or use of a mechanical ventilator
• Patients who are unable to tolerate increased pacing rates
• Indication for cardiac resynchronization therapy

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• UMC Utrecht: collaborator
• Maasstad Hospital: collaborator
• Northwest Clinics Alkmaar: collaborator

Study Sites (1)

VU university medical center

Amsterdam, 1081HV, Netherlands

RECRUITING

Related Publications (1)

• Brubaker PH, Kitzman DW. Chronotropic incompetence: causes, consequences, and management. Circulation. 2011 Mar 8;123(9):1010-20. doi: 10.1161/CIRCULATIONAHA.110.940577. No abstract available.

  PMID: 21382903 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Cornelis P Allaart, MD, PhD

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cornelis P Allaart, MD, PhD

CONTACT

+31 (0)20 4445043; cp.allaart@vumc.nl

Anne-Lotte CJ van der Lingen, MD

CONTACT

+31 (0)20 4443272; a.vanderlingen@vumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The pacing mode set by the pacemaker technician will not be disclosed to either patients or the study physician.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients enter a double blind randomized cross-over pilot study and will be randomized in a 1:1 fashion to either rate responsive (MV sensor only) function on or off. After 3 months the pacing mode will be switched to the opposite mode.

Study Record Dates

• First Submitted: July 10, 2017
• First Posted: August 1, 2017
• Study Start: August 1, 2017
• Primary Completion: August 1, 2019
• Study Completion: December 1, 2019
• Last Updated: August 2, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)