Resynchronization/Defibrillation for Ambulatory Heart Failure Trial

2014-08-27 03:47:45 | BioPortfolio


Congestive heart failure (CHF) is a common health problem that leads to frequent hospitalizations and an increased death rate. In spite of advances in drug therapy, it remains a significant public health problem. Recently, a new therapy has been developed for advanced heart failure patients with a ventricular conduction abnormality. This new therapy, called cardiac resynchronization (CRT), is a device which stimulates the atrium, the right ventricle, and the left ventricle providing synchronization of the contraction of the heart chambers. It is the addition of this therapy to an implantable cardioverter defibrillator (ICD) that will be evaluated in this study. This study will compare whether the implantation of this new therapy device, in combination with an implantable cardioverter defibrillator, will reduce total mortality and hospitalizations for CHF.


Cardiovascular mortality is decreasing in most industrial countries, however mortality for congestive heart failure is increasing. The most important predictors of mortality in heart failure patients are depressed left ventricular function, severity of symptoms (NYHA class), and ventricular conduction abnormality manifested as wide QRS. Recent advances in pharmacological therapy including ACE inhibitors, beta-blocker and spironolactone have resulted in improvement of symptoms and reduction in mortality. Population epidemiological studies demonstrated that mortality and hospitalization rate for heart failure remains very high despite recent pharmacological therapeutic progress. Recent short-term clinical trials demonstrated that cardiac resynchronization therapy (CRT) is effective in improving symptoms of heart failure, functional capacity and quality of life in patients with moderate to severe heart failure and conduction abnormality optimally treated with drug therapy. However, the data for morbidity and mortality in mild to moderate heart failure is lacking.

The objective of this trial is to determine if the addition of CRT to optimal pharmacological therapy and ICD is effect in reducing mortality and morbidity in patients with poor LV function, wide QRS and mild to moderate heart failure symptoms.

This is a double-blinded randomized control trial. A total of 1800 patients with mild to moderate heart failure symptoms, LVEF ≤ 30%, and QRS ≥ 120 ms will be included in the study. Patients will be randomized to either "ICD plus Optimal Medical Therapy (control)" or "CRT/ICD plus Optimal Medical Therapy (experimental)" in a 1:1 randomization ratio. Patients in the control group will be implanted with a single or dual chamber ICD. Patients in the experimental group will receive a device with the capabilities of CRT and ICD. Optimal Medical Therapy will include ACE inhibitors and beta-blockers. Patients will be followed on a regular basis and will have clinical evaluation, quality of life assessment, and six minute walk tests performed. The primary outcome is a composite of total mortality and heart failure hospitalization. Secondary outcome measures will include total mortality, cardiovascular mortality, sudden arrhythmic death, health related quality of life and cost economics. Patient accruement is scheduled for 4.5 years and a minimum follow of 18 months.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Heart Failure, Congestive


Optimal Medical Therapy plus ICD, Optimal Medical Therapy plus CRT/ICD


Royal Adelaide Hospital


Active, not recruiting


University of Ottawa Heart Institute

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:47:45-0400

Clinical Trials [5655 Associated Clinical Trials listed on BioPortfolio]

Prospective Evaluation of Elastic Restraint to LESSen the Effects of Heart Failure (PEERLESS-HF) Trial

The purpose of this study is to determine if patients in the HeartNet Ventricular Support System with optimal medical and device therapy arm (Treatment group) show statistically significan...

Drug-Eluting Stent Implantation Versus Optimal Medical Treatment in Patients With Chronic Total Occlusion (DECISION-CTO)

The purpose of this study is to compare the safety and effectiveness of drug-eluting stent implantation compared to optimal medical treatment in patients with chronic total occlusion.

Surgery in Addition to the Medical Treatment of Lymphedema

Lymphedema is a chronic pathology with a real impact on the quality of life of patients. Despite optimal medical management of patients, some patients still have no pitting edema on which ...

Re-evaluation of Optimal Re-synchronisation Therapy in Patients With Chronic Heart Failure

The objective of the study is to demonstrate that in patients with chronic heart failure who receive optimal medical treatment for this condition and have indication for Cardiac Resynchron...

Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure

The purpose of this study is to determine whether combined mortality and hospitalization in heart failure patients receiving optimal pharmacologic therapy can be reduced by combining optim...

PubMed Articles [23790 Associated PubMed Articles listed on BioPortfolio]

Playing it close to the vest and the clinical guidelines: Clinical guideline compliance in HFrEF patients: Role of WCD.

Guideline-directed medical therapy (GDMT) for patients with Heart Failure with reduced ejection fraction (HFrEF) has been challenging to universally achieve. Healthcare providers who seek to achieve o...

Optimal Medical Therapy Prescribing Patterns and Disparities Identified in Patients with Acute Coronary Syndromes at an Academic Medical Center in an Area with High Coronary Heart Disease-Related Mortality.

Coronary heart disease (CHD)-related mortality is high in the southern United States. A five-drug pharmacotherapy regimen for acute coronary syndromes (ACS), defined as optimal medical therapy (OMT), ...

International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial: Rationale and design.

Prior trials comparing a strategy of optimal medical therapy with or without revascularization have not shown that revascularization reduces cardiovascular events in patients with stable ischemic hear...

Medical therapy versus transurethral resection of the prostate (TURP) for the treatment of symptomatic benign prostatic enlargement (BPE): a cost minimisation analysis.

A cost minimisation analysis compares the costs of different interventions' to ascertain the least expensive over time. We compared different prostate targeted drug treatments with TURP to identify ...

Targeting optimal time for hyperbaric oxygen therapy following carbon monoxide poisoning for prevention of delayed neuropsychiatric sequelae: A retrospective study.

Delayed neuropsychiatric sequelae (DNS) are serious complications of carbon monoxide poisoning; neuropsychiatric disorders can occur within a few days of recovery from acute poisoning. Hyperbaric oxyg...

Medical and Biotech [MESH] Definitions

The illumination of an environment and the arrangement of lights to achieve an effect or optimal visibility. Its application is in domestic or in public settings and in medical and non-medical environments.

A state of well-being in which performance is optimal, often as a result of physical conditioning which may be prescribed for disease therapy.

Automated systems applied to the patient care process including diagnosis, therapy, and systems of communicating medical data within the health care setting.

The research and development of ELECTRICAL EQUIPMENT AND SUPPLIES for such medical applications as diagnosis, therapy, research, anesthesia control, cardiac control, and surgery. (From McGraw-Hill Dictionary of Scientific and Technical Terms, 6th ed)

Professions or other business activities directed to the cure and prevention of disease. For occupations of medical personnel who are not physicians but who are working in the fields of medical technology, physical therapy, etc., ALLIED HEALTH OCCUPATIONS is available.

More From BioPortfolio on "Resynchronization/Defibrillation for Ambulatory Heart Failure Trial"

Quick Search


Relevant Topics

Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...

Searches Linking to this Trial