Heart Failure

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Heart Failure Clinical TrialsGeneral Purpose: 

Receiving a diagnosis that one of the body’s most vital organs is failing is an understandably scary event. In the event of heart failure (also referred to as congestive heart failure), the heart is unable to pump sufficient quantities of blood to meet the demands of the body.

Heart failure is typically the culmination of chronic conditions such as coronary artery disease or high blood pressure, which over time, create adverse circumstances that weaken the heart and eventually leave it too weak to work as it should.

The good news, however, is that heart failure can often be successfully treated, even when the conditions that cause it to occur cannot. Over the years, research has led to significant improvements in medicines designed to improve the symptoms associated with heart failure and add years to your life.

Research has also shown that certain behavioral and lifestyle changes can also lead to significant gains in heart health. Even better news is the fact that this research is ongoing and continually uncovering new and better methods for preventing and treating heart failure, as well as the underlying conditions that lead to its development.

 

What Will Heart Failure Clinical Trials Be Like?

 The types of tests and assessments used in heart failure clinical trials will ultimately depend on the specific nature of the study and what aspects of cardiomyopathy are being investigated.

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

  • Detailed physical exam and medical history.
  • 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.
  • Chest x-ray
  • 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.
  • Ejection fraction measurement: ejection fraction is a measurement of how well your heart pumps blood, and it is used to help classify heart failure and determine the most appropriate treatment.
  • 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 heart failure, such as markers of kidney and thyroid function, as well as the marker BNP.
  • 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.

In addition, your doctor will also classify your heart failure based on the results of these tests, and in accordance with one of two scales: the New York Heart Association (NYHA) scale, or the American College of Cardiology (ACC) scale.

The NYHA scale classifies heart failure in four classes (I-IV), with Class I being asymptomatic heart failure and Class IV being the most severe.

The ACC scale classifies heart failure using four letter-based stages (A-D). This system of classification is different from the NYHA system in that it includes a stage for individuals who have risk factors for, but no evidence of heart failure (Stage A). At the other end of the spectrum are Stage D patients, who are individuals with end-stage heart failure who require hospice care. The ACC scale is typically used by doctors to identify an individual’s risk factors and administer early and aggressive treatment to prevent or delay it.

Typical Protocol for Heart Failure Clinical Trials:

Specific examples of clinical trials for the various forms of cardiomyopathy might include the following:

  • A study designed to compare the effects of a short-acting diuretic versus a long-acting diuretic in patients with heart failure to determine which one is most effective. Diuretics are medications that increase the rate at which urine forms. They are commonly used to treat conditions that result in the accumulation of excess fluid in Heart Failure Clinical Trialsthe body, as well as to treat high blood pressure and various other conditions.
  • A study designed to determine if patients who participate in a heart failure management program that provides tools to promote disease self-management (such as education, lifestyle modifications, and telephone support) can improve patients’ functional status and quality of life.
  • A long-term study designed to evaluate the prevalence of comorbid breathing disorders in patients with heart failure to determine if such disorders: a) occur more frequently in a particular age group of patients; b) occur more often in men than women; and c) are associated with the weight of the patient.
  • A randomized clinical trial to determine if standard therapy plus a new drug is superior to standard therapy plus placebo at reducing the risk of major cardiovascular events (including heart attack, stroke, and heart failure) in elderly patients with a history of specific cardiovascular risk factors.

A brief word about randomized trials and placebos:

Many clinical trials, to include Heart Failure 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.

Heart Failure Clinical TrialsOn occasion, a trial will investigate the use of a standard treatment plus a new drug compared to standard treatment plus a placebo (such as the fourth clinical trial example provided above). 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 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 classification of heart failure (e.g., ACC stage C or NYHA Class II)
  • 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:

Once you are ready to begin your search for heart failure clinical trials, the following search terms may be of use when combined with the phrase:

“heart failure”: “treatment,” “prevention,” “diagnosis,” “genetics,” “risk factors,” “exercise,” “nutrition,” “management,” and “quality of life.” “heart failure clinical trials.”

 Current Search Term:

“Heart Failure”

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A Trial to Study Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Preserved Ejection Fraction


Condition:   Heart Failure
Interventions:   Drug: Neladenoson bialanate (BAY1067197);   Drug: Neladenoson bialanate (BAY1067197);   Drug: Neladenoson bialanate (BAY1067197);   Drug: Neladenoson bialanate (BAY1067197);   Drug: Neladenoson bialanate (BAY1067197);   Drug: Placebo
Sponsor:   Bayer
Recruiting - verified May 2017


Spinal Cord Stimulation in Heart Failure


Condition:   Heart Failure
Intervention:   Device: Medtronic neurostimulation system
Sponsor:   Chang Gung Memorial Hospital
Not yet recruiting - verified March 2017


Care Optimization Through Patient and Hospital Engagement Clinical Trial for Heart Failure


Condition:   Heart Failure
Interventions:   Other: Digital Engagement;   Other: Direct Engagement
Sponsors:   Duke University;   Duke Clinical Research Institute
Recruiting - verified December 2016


A Trial to Study Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Reduced Ejection Fraction


Condition:   Heart Failure
Interventions:   Drug: Neladenoson bialanate (BAY1067197);   Drug: Neladenoson bialanate (BAY1067197);   Drug: Neladenoson bialanate (BAY1067197);   Drug: Neladenoson bialanate (BAY1067197);   Drug: Neladenoson bialanate (BAY1067197);   Drug: Placebo
Sponsor:   Bayer
Recruiting - verified May 2017


BAROSTIM THERAPY™ in Heart Failure With Reduced Ejection Fraction


Condition:   Heart Failure
Intervention:   Device: Barostim Neo™ System
Sponsor:   CVRx, Inc.
Recruiting - verified April 2017


BAROSTIM THERAPY™ In Heart Failure With Preserved Ejection Fraction


Condition:   Heart Failure
Intervention:   Device: BAROSTIM NEO™ System
Sponsor:   CVRx, Inc.
Recruiting - verified April 2017


Evaluation of Vepoloxamer in Chronic Heart Failure


Condition:   Chronic Heart Failure
Interventions:   Drug: Vepoloxamer;   Other: 5% dextrose in water
Sponsor:   Mast Therapeutics, Inc.
Terminated - verified October 2016


High Versus Low SpO2 Oxygen Therapy in Patients With Acute Heart Failure


Condition:   Heart Failure
Interventions:   Other: High SpO2;   Other: Low SpO2
Sponsors:   University of Alberta;   Heart and Stroke Foundation of Canada;   Alberta Innovates Health Solutions
Recruiting - verified April 2017


Effect of Right Bifocal Ventricular Cardiac Pacing on Serum Level Natriuretic Peptides in Patients With Heart Failure


Condition:   Heart Failure
Interventions:   Device: Pacemaker Biotronik: apical stimulation;   Device: Pacemaker Biotronik: bifocal stimulation
Sponsor:   Instituto Dante Pazzanese de Cardiologia
Recruiting - verified August 2016


Nitrate's Effect on Activity Tolerance in Heart Failure With Preserved Ejection Fraction


Condition:   Heart Failure
Interventions:   Drug: Isosorbide Mononitrate;   Drug: Placebo
Sponsors:   Adrian Hernandez;   National Heart, Lung, and Blood Institute (NHLBI);   Mayo Clinic;   University of Vermont
Completed - verified October 2016


Phase IIb Safety and Efficacy Study of Four Dose Regimens of BAY1021189 in Patients With Heart Failure With Reduced Ejection Fraction Suffering From Worsening Chronic Heart Failure (SOCRATES-REDUCED)


Condition:   Heart Failure
Interventions:   Drug: Vericiguat (BAY1021189) (1.25 mg);   Drug: Vericiguat (BAY1021189) (5 mg);   Drug: Placebo
Sponsor:   Bayer
Completed - verified October 2016


Impact of Heart Failure on Calcium Homeostasis and Mitochondrial Function in Human Skeletal Muscle


Condition:   Heart Failure
Interventions:   Procedure: Exercise training,;   Procedure: Muscle biopsy
Sponsors:   University Hospital, Montpellier;   Institut National de la Santé Et de la Recherche Médicale, France;   Ministry of Health, France;   National Cancer Institute, France;   Institut de Recherches Internationales Servier
Terminated - verified November 2016


Acupuncture on Cardiac and Autonomic Function in Human Heart Failure


Condition:   Chronic Heart Failure
Intervention:   Procedure: Acupuncture
Sponsor:   The Cleveland Clinic
Active, not recruiting - verified January 2017


Heart Failure Re-admission Risk Estimation Using NICaS System With Comparison to Serum BNP Levels


Condition:   Heart Failure
Intervention:   Device: NICaS system
Sponsor:   Tel-Aviv Sourasky Medical Center
Completed - verified July 2016


Exercise Training Associated With Inspiratory Muscle Training in Heart Failure


Condition:   Heart Failure
Intervention:   Other: Exercise training
Sponsors:   University of Sao Paulo General Hospital;   Federal University of São Paulo
Recruiting - verified May 2017


Digoxin Withdrawal in Stable Heart Failure


Condition:   Heart Failure
Interventions:   Drug: Withdrawal of digoxin;   Drug: Digoxin
Sponsor:   The Alfred
Completed - verified May 2016


Safety and Hemodynamic Effects and Pharmacokinetics of CXL-1020 in Patients With Stable Heart Failure


Condition:   Heart Failure
Interventions:   Drug: CXL-1020;   Drug: CXL-1020;   Drug: Placebo for CXL-1020 Cohort 1;   Drug: Placebo for CXL-1020 Cohort 2;   Drug: CXL-1020 Dose for Echo Cohort A;   Drug: CXL-1020 Doses for Echo Cohort B
Sponsors:   Bristol-Myers Squibb;   This trial was conducted by the previous sponsor, Cardioxyl
Completed - verified June 2016


EVIdence Based TreAtment - Heart Failure (EVITA-HF)


Condition:   Heart Failure
Intervention:  
Sponsors:   Stiftung Institut fuer Herzinfarktforschung;   Vifor Inc.
Completed - verified June 2016


Rheos HOPE4HF (Health Outcomes Prospective Evaluation for Heart Failure With Ejection Fraction (EF) ≥ 40%) Trial


Condition:   Heart Failure
Interventions:   Device: Rheos Baroreflex Activation System;   Other: Standard of care medical management
Sponsor:   CVRx, Inc.
Active, not recruiting - verified October 2016


Safety/Tolerability, Pharmacokinetics/Pharmacodynamics (PK/PD) of LCZ696 in Patients With Stable Heart Failure


Condition:   Heart Failure
Intervention:   Drug: LCZ696
Sponsor:   Novartis Pharmaceuticals
Completed - verified November 2016


TRI-V Heart Failure (HF) Implanted Cardioverter Defibrillator (ICD) Study


Condition:   Heart Failure
Intervention:   Device: Device Implantation
Sponsor:   St. Jude Medical
Completed - verified October 2016


Rheos® Diastolic Heart Failure Trial


Condition:   Diastolic Heart Failure
Intervention:   Device: Rheos Baroreflex Activation Therapy System
Sponsor:   CVRx, Inc.
Completed - verified October 2016


Hemodynamically Guided Home Self-Therapy in Severe Heart Failure Patients (HOMEOSTASIS)


Condition:   Heart Failure
Intervention:   Device: HeartPOD™ System
Sponsor:   St. Jude Medical
Completed - verified June 2016


Screening Evaluation of the Evolution of New Heart Failure (SCREEN-HF)


Condition:   Heart Failure
Intervention:   Behavioral: Early detection of heart failure
Sponsors:   Ingrid Hopper;   HBA
Completed - verified May 2016


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