CLINICAL TRIALS PROFILE FOR CARDIOLITE

All Clinical Trials for Cardiolite

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00069160 ↗	Tariquidar and Docetaxel to Treat Patients With Lung, Ovarian, Renal and Cervical Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2003-09-01	The purpose of this study is three-fold: 1) to examine the ability of the experimental drug tariquidar to improve chemotherapy results by blocking a protein (P-glycoprotein) on some cancer cells that acts to pump out cancer drugs; 2) examine how tariquidar interacts with the cancer drug docetaxel; and 3) evaluate the effectiveness of combination treatment with tariquidar and docetaxel in treating patients with lung, ovarian, or cervical cancer. Patients 18 years of age and older with recurrent or metastatic (spreading) lung, cervical, or ovarian cancer who cannot benefit from any standard treatment may be eligible for this study. Candidates will be screened with a medical history and physical examination; review of pathology slides; blood and urine tests; imaging tests, including computed tomography (CT) or magnetic resonance imaging (MRI) scans; chest x-ray, electrocardiogram (EKG); and possibly echocardiogram. Participants will undergo the following tests and procedures: Blood draw. Blood is drawn before treatment begins to establish baseline levels for future blood tests. Blood counts are done twice weekly after chemotherapy begins. Central venous catheter placement. A plastic tube is put into a major vein in the chest. It is used to give the study drugs or other medications, including antibiotics and blood transfusions, if needed, and to withdraw blood samples. The line is usually placed under local anesthesia in the radiology department or the operating room. It can stay in the body for months or be removed after each treatment is completed. Chemotherapy. Treatment cycles are 21 days. Both drugs are given on day 1 of each cycle. First, tariquidar is given as a 30-minute infusion. One hour after the tariquidar infusion, docetaxel is infused over 1 hour. (For the first cycle only, docetaxel is given in divided doses one week apart and tariquidar is administered on either day 1 or day 8. The order of tariquidar administration is randomized to generate optimal pharmacokinetic data. Patients will be hospitalized for several days during this cycle to gather research data). The tariquidar dose remains the same throughout the study. Docetaxel may be increased or decreased from cycle to cycle, based on side effects.
NCT00162032 ↗	A Study to Evaluate the Use and Safety of CARDIOLITE® in Pediatric Patients With Kawasaki Disease	Completed	Lantheus Medical Imaging	Phase 3	2005-08-01	Determine the predictive value of CARDIOLITE® rest and stress myocardial perfusion imaging (MPI) to define a pediatric population with Kawasaki Disease (KD) at high and low risk of developing cardiac events.
NCT00162045 ↗	A Trial to Determine Radiation Exposure to Organs and Assess the Safety of CARDIOLITE® in Pediatric Subjects	Completed	Lantheus Medical Imaging	Phase 1/Phase 2	2005-01-01	The purpose of this Phase I-II multicenter clinical trial is to establish dosimetry and safety profiles for CARDIOLITE® (Technetium Tc99m Sestamibi) in pediatric subjects.
NCT00162331 ↗	CARDIOLITE-413: A Study for Patients Who Had a PCI for an Acute MI	Completed	Lantheus Medical Imaging	Phase 4	2005-01-01	The purpose of this clinical study is to learn if there are any changes in how blood gets to your heart muscle and if your heart size changed after your heart attack.
NCT00162357 ↗	Post-PCI:Cardiac Imaging in Patients With Diabetes to Detect Coronary Artery Blockages Previously Opened by Angioplasty	Completed	Lantheus Medical Imaging	Phase 4	2004-04-01	The purpose of this clinical research study is determine if patients with diabetes that have undergone previous opening of a heart blockage may have a blockage that is not causing any symptoms that may be detected by imaging with Cardiolite.

Clinical Trial Conditions for Cardiolite

Condition Name

Condition Name for Cardiolite
Intervention	Trials
Breast Cancer	3
Kawasaki Disease	2
Constipation-predominant Irritable Bowel Syndrome	1
Progesterone Receptor Negative	1

Condition MeSH

Condition MeSH for Cardiolite
Intervention	Trials
Breast Neoplasms	3
Mucocutaneous Lymph Node Syndrome	2
Neoplasms	2
Irritable Bowel Syndrome	1

Clinical Trial Locations for Cardiolite

Trials by Country

Trials by Country for Cardiolite
Location	Trials
United States	47
Canada	6
Brazil	2
Taiwan	2
Philippines	1

Trials by US State

Trials by US State for Cardiolite
Location	Trials
Minnesota	3
Wisconsin	3
Washington	3
Massachusetts	3
Michigan	2

Clinical Trial Progress for Cardiolite

Clinical Trial Phase

Clinical Trial Phase for Cardiolite
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	1
Phase 2	3

Clinical Trial Status

Clinical Trial Status for Cardiolite
Clinical Trial Phase	Trials
Completed	9
Recruiting	1

Clinical Trial Sponsors for Cardiolite

Sponsor Name

Sponsor Name for Cardiolite
Sponsor	Trials
Lantheus Medical Imaging	4
Mayo Clinic	3
National Cancer Institute (NCI)	2

Sponsor Type

Sponsor Type for Cardiolite
Sponsor	Trials
Industry	6
Other	6
NIH	4

Cardiac Myosin Modulation and Related Clinical Trials: An Update and Market Analysis

Introduction to Cardiac Myosin Modulation

Cardiac myosin modulation is a cutting-edge approach in the treatment of heart failure and other cardiac conditions. This method involves targeting the cardiac myosin enzyme to either inhibit or activate its function, thereby improving heart muscle contraction and overall cardiac performance.

Current Clinical Trials in Cardiac Myosin Modulation

Aficamten: A Next-in-Class Cardiac Myosin Inhibitor

• Clinical Trial Updates: Cytokinetics is advancing its clinical trials for aficamten, a cardiac myosin inhibitor, particularly for the treatment of hypertrophic cardiomyopathy (HCM) and heart failure. Recent updates from clinical trials highlight the potential efficacy of aficamten in reducing symptoms and improving outcomes for patients with HCM and heart failure with preserved ejection fraction (HFpEF) and hypercontractility[1].

Omecamtiv Mecarbil: A Cardiac Myosin Activator

• COMET-HF Trial: The COMET-HF trial is a confirmatory Phase 3 clinical trial designed to assess the efficacy and safety of omecamtiv mecarbil in patients with symptomatic heart failure and severely reduced ejection fraction. This trial follows the positive results from the GALACTIC-HF trial, which showed a statistically significant risk reduction in heart failure outcomes with omecamtiv mecarbil. The primary endpoint of COMET-HF includes the time to first event in a composite of cardiovascular death, first heart failure event, left ventricular assist device (LVAD) implantation or cardiac transplantation, or stroke[1].

CK-4021586 (CK-586): Another Cardiac Myosin Inhibitor

• AMBER-HFpEF Trial: The AMBER-HFpEF trial is a Phase 2 clinical trial evaluating CK-586, a cardiac myosin inhibitor, for the treatment of patients with symptomatic heart failure with preserved ejection fraction (HFpEF) and hypercontractility. This trial aims to explore the safety and efficacy of CK-586 in this patient population, addressing a significant unmet need in cardiac care[1].

Market Analysis and Projections for Cardiac Myosin Modulation

Cardiovascular Clinical Trials Market

• The cardiovascular clinical trials market is expected to grow significantly, driven by the increasing incidence of cardiac disorders such as heart failure, cardiac arrest, and coronary artery diseases. By 2037, this market is projected to exceed USD 12.45 billion, growing at a CAGR of over 5.9% from 2025 to 2037. The growth is also fueled by enhanced government and industrial funding, as well as the need for post-marketing research to ensure the efficacy and safety of cardiovascular devices[3].

Cardiac Ablation Market

• The cardiac ablation market, another segment related to cardiac treatments, is valued at USD 3.86 billion in 2024 and is expected to exceed USD 20.03 billion by 2037, growing at a CAGR of over 13.4%. This growth is attributed to the increasing prevalence of cardiovascular diseases globally, with radiofrequency ablation expected to garner the highest revenue by the end of the forecast period[2].

Arterial Stent Market

• The arterial stent market, which includes coronary and peripheral stents, is also experiencing rapid growth. This market is projected to expand at a CAGR of 9.8% from 2020 to 2025, driven by the rising incidence of cardiovascular disease and the preference for minimally invasive procedures. Coronary stents are expected to dominate the market, with significant growth also anticipated in the peripheral femoral and popliteal artery segment[5].

Impact of Clinical Trials on Market Projections

Regulatory Approval and Commercial Launch

• The success of clinical trials such as COMET-HF and AMBER-HFpEF can significantly impact the market by paving the way for regulatory approvals and subsequent commercial launches. For instance, if omecamtiv mecarbil receives approval for use in patients with heart failure and severely reduced ejection fraction, it could capture a substantial market share given the high unmet need in this patient population[1].

Competitive Landscape

• Companies like Cytokinetics, with their focus on cardiac myosin modulation, are positioning themselves to capitalize on the growing demand for innovative cardiac treatments. The market is highly competitive, with other players such as Medtronic, Abbott, and Boston Scientific also investing heavily in product development and clinical trials to expand their market share[5].

Key Takeaways

• Clinical Trials: Ongoing clinical trials for aficamten, omecamtiv mecarbil, and CK-586 are crucial for advancing cardiac myosin modulation therapies.
• Market Growth: The cardiovascular clinical trials market, cardiac ablation market, and arterial stent market are all expected to grow significantly due to the increasing prevalence of cardiovascular diseases.
• Regulatory Approvals: Successful clinical trials can lead to regulatory approvals, which are critical for the commercial launch and market penetration of new cardiac treatments.
• Competitive Landscape: The market is highly competitive, with multiple players investing in research, development, and clinical trials to capture market share.

FAQs

What is cardiac myosin modulation?

Cardiac myosin modulation involves targeting the cardiac myosin enzyme to either inhibit or activate its function, thereby improving heart muscle contraction and overall cardiac performance.

What are the key clinical trials for cardiac myosin inhibitors and activators?

Key clinical trials include the COMET-HF trial for omecamtiv mecarbil, the AMBER-HFpEF trial for CK-586, and ongoing trials for aficamten.

How is the cardiovascular clinical trials market expected to grow?

The cardiovascular clinical trials market is expected to grow at a CAGR of over 5.9% from 2025 to 2037, exceeding USD 12.45 billion by 2037.

What is driving the growth of the cardiac ablation market?

The cardiac ablation market is driven by the increasing prevalence of cardiovascular diseases globally, with radiofrequency ablation expected to garner the highest revenue.

How is the arterial stent market projected to grow?

The arterial stent market is projected to expand at a CAGR of 9.8% from 2020 to 2025, driven by the rising incidence of cardiovascular disease and the preference for minimally invasive procedures.

Sources

1. Cytokinetics Highlights Progress in Cardiac Myosin Modulation - Cytokinetics Investor and Analyst Day.
2. Cardiac Ablation Market Size, Growth Analysis 2025-2037 - Research Nester.
3. Cardiovascular Clinical Trials Market Size & Share, Growth Report - Research Nester.
4. Ongoing and Upcoming Trials - Heart Recovery.
5. Coronary and Peripheral Stent Market Expected to Double Through 2025 - Diagnostic and Interventional Cardiology.