Abnormal Heart Rhythm

About Abnormal Heart Rhythm Clinical Trials (Click to Open)

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Abnormal Heart RhythmGeneral Purpose: 

Abnormal heart rhythms, or arrhythmias, refer to any disorder that affects your heart rate or rhythm. Sometimes your heart may noticeably skip a beat and create a ‘fluttering’ sensation of sorts within your chest. This can happen to anyone at any point during their lives and most of the time it is of no great significance. Sometimes, however, arrhythmias can signal that something is wrong.

When your heart consistently beats too fast (a condition known as tachycardia) or too slow (a condition known as bradycardia), or when the upper chambers of the heart (i.e., the atria) beat in a rapid, irregular pattern for an extended period of time (a condition called atrial fibrillation), you may be experiencing signs of underlying heart disease.

In fact, atrial fibrillation is a major cause of stroke. In addition, when the lower chambers of the heart (i.e., the ventricles) beat quickly and irregularly – an event known as ventricular fibrillation – they create an emergency situation in which blood pressure plummets and blood supply is cut off to the body’s vital organs. Ventricular fibrillation is a frequent cause of sudden death and requires prompt medical attention.

These abnormal heart rhythms can be caused by any number of things, including a heart attack, blood chemical imbalances, abnormal levels of certain hormones, as well as some medications.

Researchers are working hard to gain a better understanding of how heart cells communicate with each other, the causes of atrial and ventricular fibrillation, and improved methods of treating persistent arrhythmias. Research is also underway to study the genetics of heart diseases in general.

What Will Abnormal Heart Rhythm Clinical Trials Be Like?

The types of tests and assessments used in abnormal heart rhythm clinical trials will Abnormal Heart Rhythmultimately depend on the specific nature of the study and what aspects of heart disease are being investigated.

Provided below is a list of frequent procedures and tests used to evaluate the heart, heart functioning, and its impact on the body in general, many of which may be incorporated for use in clinical trials:

  • Physical exam
  • Cardiac catheterization: a procedure during which a long, thin, and flexible tube (i.e., catheter) is inserted into a blood vessel in the arm, upper thigh, or neck and threaded through until it reaches your heart. This allows doctors to perform diagnostic tests and treatments, as well as to evaluate blockages in the blood vessels.
  • Computed tomography (CT scan, or “CAT scan”) or magnetic resonance imaging (MRI) scans: these are non-invasive imaging procedures, similar to an x-ray, that allow doctors to take detailed pictures of your heart.
  • Coronary angiography: a procedure during which a dye is injected into a vein in your arm and then viewed using a special x-ray machine, CT scanner, or MRI machine. This allows doctors to view the insides of the arteries that provide blood to your heart. Angiography may also be used to evaluate other blood vessels throughout the body.
  • Echocardiography (“echo”): a painless procedure that uses ultrasound to create moving pictures of your heart, which allow doctors to see its size, shape, and how well it is working. During a procedure known as transesophageal echocardiography, a long, thin ultrasound probe is guided down the throat into the esophagus, which is directly behind the heart, in order to obtain more detailed pictures.
  • Electrocardiogram (EKG, or ECG): a straightforward and painless procedure that records the electrical activity of the heart. This test tells doctors how fast your heart is beating, the regularity (or irregularity) of your heart rhythm, and strength and timing of the electrical signals that constantly pass through the heart.
  • Blood tests to evaluate the effectiveness or chemical properties of a medication, if you are participating in a clinical trial that is investigating the use of a new drug
  • Blood tests to look for chemical markers that indicate the presence of heart disease. Examples of these markers include troponin, CK-MB enzyme, myoglobin, hs-CRP, and BNP or NT-proBNP, pH, oxygen, and carbon dioxide.
  • Nuclear heart scan: a test that uses a small but safe amount of a radioactive compound, injected into your body through a vein in the arm. This compound then travels to the heart and allows special cameras to take detailed pictures of the heart to evaluate 1) blood flow; 2) damaged heart muscle; and 3) pumping ability and efficiency.
  • Stress test: a test performed while you exercise (usually by walking or running on a treadmill, or pedaling a stationary bicycle), which allows doctors to evaluate how your heart works during episodes of physical stress.
  • Pain and quality of life assessments, as well as exercise diaries, may also be required in some studies, depending on the research question being studied.

Typical Abnormal Heart Rhythm Clinical Trial Protocol:

Abnormal Heart RhythmSpecific examples of clinical trials for conditions characterized by abnormal heart rhythm might include the following:

  • A clinical trial that compares the use of a standard catheter-delivered treatment to a new anti-arrhythmia drug for the treatment of atrial fibrillation to determine which has a greater impact on reducing mortality and decreasing the rate of serious side effects.
  • A long-term study of dialysis patients to determine if an internally implanted arrhythmia monitoring device can identify the types and frequencies of arrhythmias experienced by this patient population (which has an extremely high rate of fatal arrhythmias when compared to the general population).
  • A study designed to determine the types of arrhythmias that pediatric patients experience while receiving general anesthesia during surgery.
  • A study to determine if patients who have implantable pacemakers and who take supplemental omega-3 fatty acids have a decreased risk of experiencing ventricular arrhythmia compared to patients who do not take the supplement.

A brief word about randomized trials and placebos:

Many clinical trials involve the comparison of an investigational treatment to a “standard” treatment. Some studies determine which therapy a patient receives through a process known as randomization, in which patients are randomly assigned to receive either the investigational treatment or the standard treatment.

On occasion, a trial will investigate the use of a standard treatment plus a new drug compared to standard treatment plus a placebo. Placebos are inactive or “sham” treatments that are identical in appearance to the active treatment but have no therapeutic value.

Placebos are necessary to help determine if adverse effects that occur during the clinical Abnormal Heart Rhythmtrial are the result of the investigational treatment or due to some other factor. They also allow researchers to measure the effects of the active treatment and observe what would have happened without it.

In rare instances where no standard therapy exists, or when a new drug is being evaluated for the first time, the investigational treatment might be compared to a placebo alone. In these types of trials, those patients who are randomized to the placebo group do not receive an active treatment.

It is important to know that placebo-only trials are only conducted when scientifically necessary and when patients have been adequately informed that they may end up receiving the placebo rather than the active treatment. It is very important to note, however, that no one should ever participate in such a placebo trial when there is a widely available and highly effective standard treatment already in existence for their particular disease or condition.

Trial Eligibility and Medical Information Needed:

The type of clinical trial you may be eligible for often depends on many factors, including your history of heart disease, treatment history, and a variety of clinical findings. Therefore, it is important to know many details pertaining to your specific diagnosis when searching for clinical trials. Examples of the details you may want to have on hand include:

  • Your specific abnormal heart rhythm diagnosis (e.g., tachycardia, atrial fibrillation).
  • Your prior history of heart disease.
  • Your prior history of treatment for heart disease (including any surgeries, procedures, and medications).
  • Your current medications (including aspirin), vitamins, and dietary supplements.
  • Your most recent blood pressure, cholesterol, and triglyceride (i.e., lipid) levels.

Suggested Search Terms:

“cardiac arrhythmia,” “heart arrhythmia,” “ventricular fibrillation,” “atrial fibrillation,” “bradycardia,” “tachycardia,” “arrhythmia treatment,” “arrhythmia prevention,” “arrhythmia exercise,” “pediatric arrhythmia,” and “arrhythmia management.”

Current Search Term:

“Abnormal Heart Rhythm”

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Stellate Ganglion Block in Beating Heart Surgery

Condition:   Cardiac Arrythmias
Intervention:   Drug: stellate ganglion block
Sponsor:   Assiut University
Not yet recruiting

Remote Patient Management of CIEDs

Condition:   Cardiac Arrhythmia
Interventions:   Device: Remote Patient Management;   Device: Standard of Care
Sponsors:   Ratika Parkash;   Cardiac Arrhythmia Network of Canada
Not yet recruiting

Cardiac Rhythm Disturbances in Hard-to-treat Epilepsy Patients Using Loop ECG Recorders

Condition:   Epilepsy
Sponsors:   National Research Center for Preventive Medicine;   Pirogov Russian National Research Medical University
Active, not recruiting

Esophageal 3D Mapping System for Cardiac Arrhythmias

Conditions:   Arrhythmia;   Atrial Fibrillation;   Atrial Flutter;   Atrial Tachycardia;   Supraventricular Tachycardia;   Ventricular Ectopic Beat(S);   Cardiac Arrythmias
Intervention:   Device: esoECG-3D catheter
Sponsor:   University Hospital Inselspital, Berne
Not yet recruiting

EnSite Precision Observational Study

Condition:   Cardiac Arrhythmia
Intervention:   Procedure: cardiac mapping and radiofrequency ablation procedure
Sponsor:   St. Jude Medical

Post Discharge Circadian Rhythms Post Adenotonsillectomy

Condition:   Circadian Dysrhythmia
Intervention:   Device: Jawbone UP4
Sponsor:   Baylor College of Medicine

Pilot Study for the Tight K Study

Condition:   Cardiac Arrythmias
Intervention:   Drug: Potassium
Sponsors:   Barts & The London NHS Trust;   London School of Hygiene and Tropical Medicine

Biomagnetic Characterization of Gastric Dysrhythmias III

Conditions:   Diabetics Without Symptoms of Gastroparesis;   Diabetic Gastroparesis;   Idiopathic Gastroparesis;   Total or Partial Gastrectomy;   Chronic Nausea;   Functional Dyspepsia
Intervention:   Diagnostic Test: magnetogastrogram
Sponsors:   Vanderbilt University Medical Center;   National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Enrolling by invitation

Hypoglycaemia and Cardiac Arrhythmias in Type 2 Diabetes

Conditions:   Diabetes Mellitus, Type 2;   Arrhythmia, Cardiac
Interventions:   Other: Combined hyper- and hypoglycaemic clamp;   Device: Loop recorder (Reveal LINQ, Medtronic, Minneapolis, MN, USA);   Device: Continuous glucose monitoring (iPro2, Medtronic, Minneapolis, MN, USA)
Sponsor:   University Hospital, Gentofte, Copenhagen
Enrolling by invitation

Cardiac Arrhythmias and Dysfunction in the Pediatric Burn Patient

Condition:   Cardiac Dysfunction
Intervention:   Diagnostic Test: Echocardiogram
Sponsor:   Shriners Hospitals for Children
Enrolling by invitation

RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY)

Condition:   Cardiac Arrythmias
Intervention:   Device: Rhythmia Mapping System
Sponsor:   Boston Scientific Corporation

Cardiac Arrhythmias in Patients Undergoing Kidney Cancer Surgery Depending on the Anaesthesia Method

Conditions:   Arrhythmia, Cardiac;   Kidney Cancer;   Surgery;   Anesthesia, Local
Interventions:   Drug: Bupivacaine-fentanyl;   Device: Holter ECG monitor;   Procedure: Open kidney cancer surgery;   Procedure: General anesthesia;   Procedure: Epidural Anaesthesia
Sponsor:   Medical University of Warsaw

Maestro Handheld Cardiac Monitor Validation

Condition:   Cardiac Arrhythmia
Intervention:   Other: Maestro ECG
Sponsor:   University of Michigan

3T MRI CIED Post-Approval Study

Condition:   Cardiac Rhythm Disorder
Sponsor:   Medtronic

Same Day Discharge

Condition:   Cardiac Arrhythmia
Intervention:   Other: Discharge day of procedure
Sponsor:   University of Cincinnati

SJM MRI Diagnostic Imaging Registry (IDE)

Condition:   Cardiac Arrhythmia
Intervention:   Device: Pacemaker, ICD, or CRT device
Sponsor:   St. Jude Medical

EnSite Precision™ 2.0 Registry

Condition:   Cardiac Arrhythmias
Intervention:   Procedure: Cardiac Ablation
Sponsor:   St. Jude Medical
Active, not recruiting

Sparsity-based Magnetic Resonance Imaging of Cardiac Arrhythmias

Condition:   Cardiac Arrythmias
Interventions:   Other: 3D Imaging;   Other: Late Gadolinium Enhancement (LGE)
Sponsor:   New York University School of Medicine

Prospective Registry on User Experience With The Mapping System For Ablation Procedures

Condition:   Cardiac Arrhythmias
Interventions:   Device: Rhythmia mapping system;   Device: IntellaMap Orion mapping catheter
Sponsor:   Boston Scientific Corporation

Cardiac Arrhythmias in Dravet Syndrome

Condition:   Epilepsy
Sponsors:   Stichting Epilepsie Instellingen Nederland;   Epilepsiefonds

Derivation of Human Induced Pluripotent Stem (iPS) Cells to Heritable Cardiac Arrhythmias

Conditions:   Inherited Cardiac Arrythmias;   Long QT Syndrome (LQTS);   Brugada Syndrome (BrS);   Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT);   Early Repolarization Syndrome (ERS);   Arrhythmogenic Cardiomyopathy (AC, ARVD/C);   Hypertrophic Cardiomyopathy (HCM);   Dilated Cardiomyopathy (DCM);   Muscular Dystrophies (Duchenne, Becker, Myotonic Dystrophy);   Normal Control Subjects
Sponsor:   Johns Hopkins University
Enrolling by invitation

Electrical Signal Collection From a 20 Pole Catheter During Routine Cardiac Procedures

Condition:   Cardiac Arrhythmias
Intervention:   Other: Intracardiac electrode catheter
Sponsor:   Medtronic Cardiac Rhythm and Heart Failure

Genetics of QT Response to Moxifloxacin

Condition:   Cardiac Arrhythmias
Interventions:   Drug: Moxifloxacin 400mg once time;   Drug: Placebo
Sponsor:   Massachusetts General Hospital
Enrolling by invitation

PANORAMA 2 Observational Study

Condition:   Heart Rhythm Disorders
Sponsor:   Medtronic Bakken Research Center

Patient Reported Outcome Measures for Ablation of Cardiac Arrhythmias

Condition:   Cardiac Arrhythmia
Interventions:   Other: Interview;   Other: Questionnaires
Sponsors:   Cardiff and Vale University Health Board;   National Institute for Health and Clinical Excellence;   University Hospital Birmingham NHS Foundation Trust;   Newcastle-upon-Tyne Hospitals NHS Trust;   University College, London
Active, not recruiting

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