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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EnSite Precision Observational Study


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


Post Discharge Circadian Rhythms Post Adenotonsillectomy


Condition:   Circadian Dysrhythmia
Intervention:   Device: Jawbone UP4
Sponsor:   Baylor College of Medicine
Not yet recruiting


Pilot Study for the Tight K Study


Condition:   Cardiac Arrythmias
Intervention:   Drug: Potassium
Sponsors:   Queen Mary University of London;   London School of Hygiene and Tropical Medicine
Not yet recruiting


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


Clinical Utility and Validation of the Rhythmia Mapping System for the Treatment of Cardiac Arrhythmias


Conditions:   Cardiac Arrhythmias;   Electroanatomic Mapping;   Cardiac Ablation
Intervention:   Device: Rhythmia Mapping System
Sponsors:   Beth Israel Deaconess Medical Center;   Boston Scientific Corporation
Completed


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
Recruiting


COMParison of Algorithms for Rotational Evaluation in Atrial Fibrillation


Conditions:   Atrial Fibrillation;   Abnormal Heart Rhythms
Intervention:  
Sponsor:   Stanford University
Recruiting


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
Completed


Maestro Handheld Cardiac Monitor Validation


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


3T MRI CIED Post-Approval Study


Condition:   Cardiac Rhythm Disorder
Intervention:  
Sponsor:   Medtronic
Recruiting


Same Day Discharge


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


SJM MRI Diagnostic Imaging Registry (IDE)


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


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
Not yet recruiting


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
Completed


Cardiac Arrhythmias in Dravet Syndrome


Condition:   Epilepsy
Intervention:  
Sponsors:   Stichting Epilepsie Instellingen Nederland;   Epilepsiefonds
Recruiting


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
Intervention:  
Sponsor:   Johns Hopkins University
Enrolling by invitation


Cardiac Arrhythmias in Epilepsy: the CARELINK-study


Conditions:   Epilepsy;   Asystole;   Cardiac Arrhythmias
Intervention:   Device: implantable heart rate monitor
Sponsors:   Stichting Epilepsie Instellingen Nederland;   Fonds NutsOhra;   Medtronic
Completed


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
Intervention:  
Sponsor:   Medtronic Bakken Research Center
Completed


ENHANCED Device Programming to Reduce Therapies and Improve Quality of Life in Implantable Cardioverter Defibrillator (ICD) Patients


Condition:   Cardiac Arrhythmias
Intervention:   Device: Enhanced ICD programming
Sponsors:   M. Meine;   Medtronic;   University of Tilburg;   Julius Center
Unknown status


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


Biomagnetic Characterization of Gastric Dysrhythmias:Study 2


Condition:   Ischemia
Intervention:  
Sponsors:   Vanderbilt University Medical Center;   National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Completed

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