Heart Disease

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Heart Disease Clinical TrialsGeneral Purpose: 

Heart disease is a general term used to refer to a variety of conditions that adversely affect the heart, including coronary heart disease (also called coronary artery disease), abnormal heart rhythm (also known as arrhythmia), heart infections, and birth defects of the heart. Heart disease clinical trials generally focus on these areas.

Sometimes, the term “heart disease” is used interchangeably with the term “cardiovascular disease;” however, it is important to know that cardiovascular disease typically refers to conditions that are characterized by narrowed or blocked blood vessels, and therefore can pertain to any area of the body. Nevertheless, cardiovascular diseases most often lead to heart attack (also called myocardial infarction), chest pain (or angina), and/or stroke.

If you have been diagnosed with heart disease, you are not alone. Heart disease is the leading cause of death for both men and women. Hundreds of thousands of individuals in the United States are diagnosed with some form of heart disease each year, and millions more have significant risk factors that place them at an increased risk for developing heart disease.

In addition, heart disease places a substantial financial burden on our healthcare system. In 2010, coronary heart disease alone cost the United States nearly $110 billion for health care services, medications, and lost productivity due to illness. 

Due to its widespread prevalence and significant impact on the United States health care system and overall economy, heart disease is one of the most widely-researched health topics in the United States and around the world. So, if you have received a diagnosis of heart disease, rest assured that scientists and researchers are hard at work studying new and improved ways to prevent, diagnose, treat, and even cure the multitude of heart diseases that occur.

What Will Heart Disease Clinical Trials Be Like?

The types of tests and assessments used in heart disease clinical trials will ultimately depend on the specific nature of the study and more importantly, which particular heart disease (or diseases) is/are being studied. Provided below is a list of frequent proceduresHeart Disease Clinical Trials 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
  • Detailed family history of heart diseases.
  • Genetic testing
  • 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 Protocol for Heart Disease Clinical Trials:

Specific examples of heart disease clinical trials might include the following:

  • An observational study to evaluate how pregnant women with heart disease are managed in terms of the anesthesia they receive during delivery (e.g., epidural, oral medications, general anesthesia).
  • A study in which infants born with a particular heart defect are treated with a new drug prior to and following standard corrective surgery for the defect, to determine if Heart Disease Clinical Trialsuse of the drug is effective at minimizing the risk of surgery-related brain damage.
  • A randomized study to determine if a broad combination of behavioral interventions and medications is more effective at reducing the risk of new heart disease development and death in individuals who have already been diagnosed with a particular form of heart disease. In this study, the patients randomized to receive the combined interventions would be compared to a control group of heart disease patients who received only standard treatment for their heart disease. For additional information on randomized studies, please see the section immediately following this listing of sample clinical trials.
  • A long-term study designed to evaluate new and potentially useful blood markers that are associated with the prognosis of patients with heart disease. In such a study, volunteers with heart disease would be required to give blood samples at specified intervals of time over the course of 12 months so that researchers could examine their blood for the presence of specific chemicals and compounds that might be associated with their long-term outcome.

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. 

Heart Disease Clinical TrialsPlacebos are necessary to help determine if adverse effects that occur during the clinical trial 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 or therapy is being investigated, 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 diagnosis of heart disease (e.g., coronary artery disease, arrhythmia, mitral valve prolapse) – or – if you have not been diagnosed with heart disease but have been told you are at risk for developing it, it is important to know the specific risk factors that you have, such as obesity, smoking, or family history.
  • 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: 

“heart disease prevention,” “heart disease management,” “heart disease treatment,” “heart disease genetics,” “heart disease healthy volunteer,” “heart disease birth defects,” “heart disease diet,” “heart disease exercise,” “heart disease diabetes,” “heart disease obesity,” “heart disease rehabilitation,” “heart disease risk,” “heart disease clinical trials,” “heart disease pregnancy,” “heart disease men,” and “heart disease women.”

Current Search Term:

“Heart Disease”

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Genomic Basis of Neurodevelopmental and Brain Outcomes in Congenital Heart Disease (CHD Brain and Genes)


Condition:   Heart Disease Congenital
Interventions:   Other: Exposure of interest: Brain MRI;   Other: Exposure of interest: neurodevelopmental assessments
Sponsors:   Children's Hospital Medical Center, Cincinnati;   National Heart, Lung, and Blood Institute (NHLBI);   Pediatric Cardiac Genomics Consortium
Not yet recruiting - verified March 2017


Valvular Heart Disease Registry Study in Second Affiliated Hospital of ZheJiang University


Condition:   Valvular Heart Disease
Intervention:  
Sponsor:   Second Affiliated Hospital, School of Medicine, Zhejiang University
Not yet recruiting - verified December 2016


Assessing Neurodevelopment in Congenital Heart Disease.


Condition:   Congenital Heart Disease
Interventions:   Procedure: Sonography;   Device: Magnetic Resonance Imaging;   Other: Bailey Test;   Procedure: Surgical intervention;   Procedure: Brain monitoring;   Procedure: cord blood sample
Sponsors:   Hospital Universitari Vall d'Hebron Research Institute;   Hospital Sant Joan de Deu;   Hospital Universitario La Paz;   Hospital Universitario 12 de Octubre;   Hospital General Universitario Gregorio Marañon;   Institut Universitari Dexeus
Recruiting - verified October 2016


Surgery and Transcatheter Intervention for Structural Heart Diseases


Condition:   Data Collecting and Analyzing of Different Treatment of Structural Heart Diseases
Intervention:  
Sponsors:   Xijing Hospital;   Fu Wai Hospital, Beijing, China;   Beijing Anzhen Hospital;   Wuhan Union Hospital, China
Recruiting - verified September 2016


Study on the Relationship Between Maternal Exposure to Environmental Factors and Fetal Congenital Heart Disease


Condition:   Congenital Heart Disease
Intervention:  
Sponsor:   Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Not yet recruiting - verified September 2016


Northwest Adult Congenital Heart Disease Observatory


Condition:   Congenital Heart Disease
Intervention:   Other: description
Sponsor:   University Hospital, Caen
Not yet recruiting - verified September 2016


Mobile Health in Structural Heart Disease


Conditions:   Rheumatic Heart Disease;   Heart Diseases
Interventions:   Device: mHealth;   Other: Standard-Care
Sponsor:   Sri Sathya Sai Institute of Higher Medical Sciences
Completed - verified August 2016


Exercise Training in Grown-up Congenital Heart Disease


Condition:   Congenital Heart Disease
Intervention:   Behavioral: exercise training
Sponsor:   Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Recruiting - verified July 2016


Brain Function in Children With Congenital Heart Disease (CHD)


Condition:   Congenital Heart Disease
Intervention:  
Sponsors:   Bea Latal;   University of Zurich;   Mäxi Foundation
Enrolling by invitation - verified June 2016


Biventricular Pacing in Children After Surgery for Congenital Heart Disease


Condition:   Congenital Heart Disease (CHD)
Intervention:   Other: Biventricular pacing
Sponsor:   The Hospital for Sick Children
Completed - verified June 2016


Peri-conception Key Nutritional Factors and Congenital Heart Disease


Condition:   Congenital Heart Disease
Intervention:   Other: observation
Sponsor:   Children's Hospital of Fudan University
Recruiting - verified May 2017


A Partnership to Translate an Evidence-based Intervention (Take Heart) for Vulnerable Older Adults With Heart Disease


Condition:   Heart Diseases
Intervention:   Behavioral: Take Heart
Sponsors:   University of Michigan;   National Institute on Aging (NIA);   Detroit Medical Center;   Detroit Area Agency on Aging
Recruiting - verified January 2017


Rheumatic Heart Disease Study in Lusaka


Condition:   Rheumatic Heart Disease
Intervention:  
Sponsors:   University of Zambia;   University of Cape Town;   Novartis
Completed - verified November 2016


Infant Nasal Nitric Oxide Levels in Congenital Heart Disease


Condition:   Congenital Heart Disease
Intervention:   Device: Measurement of nasal Nitric Oxide level
Sponsors:   University of Alberta;   Women and Children's Health Research Institute, Canada
Recruiting - verified May 2017


Quality of Life in Young Adults With Congenital Heart Disease


Condition:   Congenital Heart Disease
Intervention:   Other: no intervention
Sponsor:   University Children's Hospital, Zurich
Completed - verified June 2016


Biventricular Pacing in Children With Congenital Heart Disease


Condition:   Congenital Heart Disease (CHD)
Intervention:   Device: Biventricular Pacing (BiVp)
Sponsor:   The Hospital for Sick Children
Recruiting - verified April 2017


National Congenital Heart Disease Audit


Condition:   Congenital Heart Disease (CHD)
Interventions:   Procedure: Cardiac Surgery;   Procedure: Therapeutic cardiac catheterisations procedures
Sponsors:   University College, London;   Society for Cardiothoracic Surgery in Great Britain & Ireland;   British Congenital Cardiac Association
Recruiting - verified October 2016


Risk Factors for Acquired Cardiovascular Disease in Adults With Congenital Heart Disease


Condition:   Congenital Heart Disease
Intervention:  
Sponsor:   Stanford University
Enrolling by invitation - verified April 2017


RhEumatiC Heart diseAse Genetics


Condition:   Rheumatic Heart Disease
Intervention:   Genetic: Next generation sequencing
Sponsors:   Brigham and Women's Hospital;   National University, Rwanda
Recruiting - verified July 2016


Assessment of the Efficacy of the First Aspirin Dose in Children Undergoing Surgery for Congenital Heart Disease (CHD) Who Require Post-operative Antiplatelet Therapy


Condition:   Congenital Heart Disease
Intervention:  
Sponsor:   University of Colorado, Denver
Active, not recruiting - verified August 2016


The Genetic Basis of Congenital Heart Disease in Africa


Conditions:   Congenital Heart Disease;   Heart Disease
Intervention:  
Sponsors:   National Human Genome Research Institute (NHGRI);   University of Lagos, Nigeria;   Uganda Heart Institute, Kampala, Uganda
Recruiting - verified July 22, 2016


Accuracy of Peripheral Pulse Oximetry Versus Arterial Co-oximeter in Children With Cyanotic Heart Disease


Condition:   Cyanotic Heart Disease
Intervention:  
Sponsor:   Stanford University
Completed - verified March 2017


Quality of Life Among Children With Congenital Heart Disease


Condition:   Congenital Heart Disease
Intervention:  
Sponsor:   University Hospital, Montpellier
Completed - verified August 2016


Genetics of Congenital Heart Disease


Condition:   Congenital Heart Disease
Intervention:   Other: Blood Sample Collection
Sponsors:   Nationwide Children's Hospital;   National Heart, Lung, and Blood Institute (NHLBI)
Recruiting - verified February 2017


Parenteral Phenoxybenzamine During Congenital Heart Disease Surgery


Condition:   Congenital Heart Disease
Interventions:   Drug: Phenoxybenzamine;   Other: Standard surgical approach
Sponsor:   Vanderbilt University
Withdrawn - verified April 2017

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