The Influence of Heart Rate Limitation on Exercise Tolerance in Pacemaker Patients.

NCT02247245 | Completed Results

• 1 other identifier: LIGHT-TREPPE-1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

To examine the effects of heart rate reduction on exercise capacity in control subjects and patients with chronic heart failure.

Conditions

Chronic Heart Failure; Atrial Fibrillation; Arrhythmia, Sinus

Keywords

CHF; AF; SR; HFREF; CRT

Outcome Measures

Primary Outcomes (1)

• Maximal Oxygen Consumption (Peak VO2)

  Cardiopulmonary exercise testing performance - measuring peak oxygen uptake during a treadmill CPEX test. Subjects were exercised using the Bruce protocol, modified by the addition of a "stage 0" at onset consisting of 3 min of exercise at 1.61 km·h-1 (1 mile·h-1) with a 5% gradient. Expired air was collected and metabolic gas exchange analysis performed in order to measure the maximal oxygen consumption (peak VO2) (Sensormedics, Yorba Linda, California). The CPX equipment was recalibrated before every exercise test. All test subjects were encouraged to exercise to exhaustion before starting the test, and no further motivation or instructions were given.

  Each test lasts up to 20 minutes

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Subjects are given a placebo capsule (double-blinded) to take 90 minutes prior to the cardiopulmonary exercise test.

Drug: Placebo

Ivabradine

ACTIVE COMPARATOR

Subjects are given an ivabradine capsule (double-blinded) to take 90 minutes prior to the cardiopulmonary exercise test.

Drug: Ivabradine

Atrial fibrillation

EXPERIMENTAL

Subjects are (double blind) randomised to either a low base pacing rate (30) or a standard base rate (60), with rate adaptive algortithms switched on.

Other: Atrial fibrillation

Interventions

Ivabradine DRUG

Ivabradine 7.5mg

Also known as: Precorolan

Ivabradine

Atrial fibrillation OTHER

Pacemaker base rate alteration

Atrial fibrillation

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Leeds: lead

Study Sites (1)

Leeds Institute of Cardiovascular and Metabolic Medicine

Leeds, West Yorkshire, LS13ex, United Kingdom

Location

Related Publications (1)

• Jamil HA, Gierula J, Paton MF, Byrom R, Lowry JE, Cubbon RM, Cairns DA, Kearney MT, Witte KK. Chronotropic Incompetence Does Not Limit Exercise Capacity in Chronic Heart Failure. J Am Coll Cardiol. 2016 Apr 26;67(16):1885-96. doi: 10.1016/j.jacc.2016.02.042.

  PMID: 27102504 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmia, Sinus

Interventions

Ivabradine

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr Haqeel Jamil
• Organization: University of Leeds

haqeel.jamil@nhs.net

0113 343 3241

Study Officials

• Klaus K Witte, FRCP MD

  University of Leeds

  PRINCIPAL INVESTIGATOR

• Haqeel A Jamil, MbChB MRCP

  University of Leeds

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiology Registrar and Clinical Research Fellow

Study Record Dates

• First Submitted: September 19, 2014
• First Posted: September 23, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: January 2, 2020
• Results First Posted: January 2, 2020

Record last verified: 2019-12

Locations

GB (1)