Effects of Atrial Rate-adaptive Pacing on Exercise Capacity in Patients With Chronic Heart Failure Complicated by Chronotropic Incompetence

2014-08-27 03:17:51 | BioPortfolio


Chronotropic incompetence consists of an insufficient increase in heart rate during effort, and its presence is recognized as a common feature in patients with heart failure due to left ventricular systolic dysfunction, apparently suggesting a worse prognosis. Little is known about the possible benefits of its reversal in such patients.

The investigators working hypothesis is that the modulation of chronotropic response, as obtained by means of atrial rate-adaptive pacing may improve functional capacity in persons with chronic heart failure and chronotropic incompetence.

To explore this hypothesis,the investigators will enroll 20 patients with NYHA II/III heart failure, low left ventricular ejection fraction (<40%) and chronotropic incompetence (Maximal heart rate <80% of predicted value in a symptom-limited incremental test), who already underwent implantation of dual-chamber implantable defibrillator for prevention of sudden cardiac death. The study will have a randomized, double-blind, cross-over design.

The procedures, to be carried out at one month from each reprogrammation (VVI backup pacing vs. AAI-R "active" pacing), will comprise: blood sampling for NT-proBNP, incremental symptom-limited cardiopulmonary exercise testing (CPX), constant-workload cardiopulmonary test (50% of max WR), quality-of-life questionnaire, 24-hour ECG monitoring.

The primary end-point will be peak oxygen consumption on CPX. Secondary end-points will include acute response to reprogrammation, and data derived from constant-WR tests, Holter monitoring and QoL.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Heart Failure


Rate-adaptive pacemaker programming, VVI at 40 bpm


Federico II University - Department of Internal Medicine




Federico II University

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:17:51-0400

Clinical Trials [3261 Associated Clinical Trials listed on BioPortfolio]

Optimising Pacemaker Therapy for Contractility

The investigators have demonstrated that they can reliably identify an optimum heart rate range for contractility of the left ventricle in patients with chronic heart failure (CHF). They h...

A Pilot Study: Preventing Adverse Remodelling Following Pacemaker Implantation

Almost 40,000 people in the United Kingdom receive a new pacemaker annually. Because the pacemaker does not use the heart's normal conduction system, electrical activity from the pacemaker...

APPROPRIATE - Rate Adaptive Pacing Sensor

The APPROPRIATE study will compare differences in functional capacity (peak VO2) between chronotropically incompetent patients randomized to receive rate responsive pacing driven by either...

Effect of Chronic Changes in Heart Rate on Congestive Heart Failure

This will be a double blind randomized crossover study of patients with congestive heart failure and a heart rate dependent upon a permanent pacemaker. Thus, at all times the heart rate ca...

Reprogramming to Prevent Progressive Pacemaker-induced Remodelling

The aim is to provide evidence of the long-term benefits of personalised pacemaker programming on heart function and battery longevity. This will be achieved by showing in a single centre...

PubMed Articles [13971 Associated PubMed Articles listed on BioPortfolio]

Heart rate control or tailored heart rate to improve ventriculo-arterial coupling in heart failure?

Acute Heart Failure in the Emergency Department: Respiratory Rate as a Risk Predictor.

Several risk scores can stratify patients with acute heart failure (AHF) at the Emergency Department (ED). Registration of vital signs, such as blood pressure (BP), heart rate (HR) and respiratory rat...

Pacemaker Lead Surveillance and Failure: Is There a Signal in the Noise?

The role of heart rate variability, heart rate turbulence, and deceleration capacity in predicting cause-specific mortality in chronic heart failure.

The volume of regional denervated myocardium (D-M) on positron emission tomography has been recently suggested as a strong independent predictor of cause-specific mortality from sudden cardiac arrest ...

Symptomatic bradycardia with exitblock in a leadless pacemaker.

The pacemaker is the treatment of choice for symptomatic bradycardic arrhythmias. However, pacemaker patients may develop further bradycardial arrhythmias, often due to a pacemaker dysfunction. The p...

Medical and Biotech [MESH] Definitions

A heterogeneous condition in which the heart is unable to pump out sufficient blood to meet the metabolic need of the body. Heart failure can be caused by structural defects, functional abnormalities (VENTRICULAR DYSFUNCTION), or a sudden overload beyond its capacity. Chronic heart failure is more common than acute heart failure which results from sudden insult to cardiac function, such as MYOCARDIAL INFARCTION.

Regulation of the rate of contraction of the heart muscles by an artificial pacemaker.

Enlargement of the HEART, usually indicated by a cardiothoracic ratio above 0.50. Heart enlargement may involve the right, the left, or both HEART VENTRICLES or HEART ATRIA. Cardiomegaly is a nonspecific symptom seen in patients with chronic systolic heart failure (HEART FAILURE) or several forms of CARDIOMYOPATHIES.

A cardiotonic glycoside obtained mainly from Digitalis lanata; it consists of three sugars and the aglycone DIGOXIGENIN. Digoxin has positive inotropic and negative chronotropic activity. It is used to control ventricular rate in ATRIAL FIBRILLATION and in the management of congestive heart failure with atrial fibrillation. Its use in congestive heart failure and sinus rhythm is less certain. The margin between toxic and therapeutic doses is small. (From Martindale, The Extra Pharmacopoeia, 30th ed, p666)

A set of models of how communication impacts and is impacted by subjective experience. Techniques are generated from these models by sequencing of various aspects of the models in order to change someone's internal representations. Neurolinguistic programming is concerned with the patterns or programming created by the interactions among the brain, language, and the body, that produce both effective and ineffective behavior.

More From BioPortfolio on "Effects of Atrial Rate-adaptive Pacing on Exercise Capacity in Patients With Chronic Heart Failure Complicated by Chronotropic Incompetence"

Quick Search


Relevant Topics

Cardiovascular disease (CVD)
Acute Coronary Syndromes (ACS) Blood Cardiovascular Dialysis Hypertension Stent Stroke Vascular Cardiovascular disease (CVD) includes all the diseases of the heart and circulation including coronary heart disease (angina...

Benign Prostatic Hyperplasia (BPH) Erectile Dysfunction Urology Urology is the branch of medicine concerned with the urinary tract and diseases that affect it. Examples include urethritis, urethrostenosis and incontinence. Urology is a su...

Searches Linking to this Trial