Is NCT07207811 recruiting in Orange, CA?

Yes, NCT07207811 is currently recruiting participants at its Orange, CA location. This transthyretin amyloid cardiomyopathy (attr cm) clinical trial is actively enrolling qualified participants.

Is participation in this Orange clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Transthyretin Amyloid Cardiomyopathy (ATTR CM) Clinical Trial in Orange, CA

Q: How do I join the transthyretin amyloid cardiomyopathy (attr cm) clinical trial in Orange?

To join this clinical trial in Orange, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Transthyretin Amyloid Cardiomyopathy (ATTR CM) Study in Orange

This study will find out if a new medicine called NNC6019-0001 can help reduce the risk of heart-related death and illness in participants with a condition called transthyretin amyloid cardiomyopathy (ATTR-CM), which affects the heart. Participants will either receive NNC6019-0001 or a placebo (a treatment with no active medicine), and which one they get is decided by chance. Everyone in the study will continue receiving their usual heart treatments as recommended by their doctor.

Sponsor: Novo Nordisk A/S

Who Can Participate

Inclusion Criteria

Male or female.

Age 18 years or above at the time of signing the informed consent.

Have an established diagnosis of ATTR-CM (wild-type ATTR \[ATTRwt\] or variant ATTR \[ATTRv\]), with cardiac amyloid infiltration, increased left ventricular (LV) wall thickness, and HF. Note: Target ATTRv recruitment is approximately 15 percent of the study population. a. Cardiac amyloid infiltration demonstrated by: i. Cardiac biopsy positive for TTR amyloid, OR ii. Grade 2 or 3 cardiac uptake at pyrophosphate (PYP)/diphosphono-1,2-propanodicarboxylic acid (DPD)/ hydroxymethylene diphosphonate (HMDP) nuclear medicine imaging with single-photon emission computed tomography (SPECT) or SPECT/CT (preferably) combined with an extracardiac biopsy positive for TTR amyloid, OR iii. Grade 2 or 3 cardiac uptake at PYP/DPD/HMDP nuclear medicine imaging with SPECT or SPECT/CT (preferably) combined with normal serum free light chain ratio, and negative serum and urine protein electrophoresis with immunofixation (SPIE \& UPIE)/or mass spectrometry based methods including mass fixation). Notes:

Non-invasive diagnostic pathway will be confirmed by a centralised expert review.

Bone tracer nuclear medicine imaging with SPECT or SPECT/CT (preferably) will be conducted using 99m-technetium (Tc)-labelled pyrophosphate (99mTc-PYP), 99mTc-labelled 3,3-diphosphono-1,2-propanodicarboxylic acid (99mTc-DPD), or 99mTc-labeled hydroxymethylene diphosphonate (99mTc-HMDP).

The eGFR adjusted acceptable serum free light chain ratio.

Patients with Grade 2 or 3 cardiac uptake at PYP/DPD/HDMP nuclear imaging with SPECT or SPECT/CT (preferably) and evidence of monoclonal gammopathy of undetermined significance (MGUS; based on serum and urine protein electrophoresis and serum free light chains) will require endomyocardial biopsy with typing using mass spectrometry or immunohistochemistry to confirm presence of TTR protein in tissue.

Timing of serum free light chain ratio, SPIE, UPIE and mass spectrometry-based methods including mass fixation should be within 12 months of SPECT or SPECT/CT nuclear imaging. b. Increased LV wall thickness, as assessed by centralised review of echocardiography, showing interventricular septal wall thickness greater than or equal to 12 millimeter (mm). c. Chronic HF (New York Heart Association \[NYHA\] Class I-IV): i. At least 1 documented hospitalisation for HF, OR ii. History of HF manifested by signs or symptoms of volume overload or elevated intracardiac pressures (e.g., elevated jugular venous pressure, shortness of breath, signs of pulmonary congestion on x-ray or auscultation, or peripheral oedema that required or requires ongoing treatment with a diuretic).

Expected to be on stable cardiovascular medical therapy (defined as no greater than 50 percent dose adjustment and no categorical changes of medications), with the exception of diuretics, 4 weeks prior to the randomisation visit.

Completed more than 50 meters on the 6MWT at screening.

Exclusion Criteria

Known or suspected hypersensitivity to study intervention(s) or related products.

Current or previous participation (dosing with active treatment) in a study for an investigational ATTR depleting drug or ATTR gene editing therapy.

Total bilirubin greater than 3 times the upper limit of normal (ULN) at screening.

Current diagnosis or history of amyloid light chain, other non-ATTR amyloidosis, known leptomeningeal amyloidosis, or multiple myeloma.

HF not primarily caused by ATTR-CM (e.g., due to hypertension, valvular heart disease, or ischemic heart disease in the opinion of the investigator).

Currently hospitalised or hospitalised within 14 days prior to screening.

Currently treated with positive inotropic medication.

Uncorrected, severe, haemodynamically significant, left-sided heart valve disease.

Acute coronary syndrome, unstable angina, stroke, transient ischemic attack, coronary revascularisation, cardiac device implantation, cardiac valve repair, or major surgery within 60 days of screening.

Prior solid organ transplant or planned solid organ transplant during the study.

Left ventricular ejection fraction (LVEF) less than 30 percent as assessed by centralised review of echocardiography.

Presence or history of malignant neoplasm (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, carcinoma in situ/high-grade prostatic intraepithelial neoplasia \[PIN\], low-risk prostate cancer, or on stable therapy for prostate cancer) within 3 years before screening.

End-stage renal disease (estimated glomerular filtration rate \[eGFR\] less than 15 mL/min/1.73 m\^2 at screening, or chronic/intermittent haemodialysis or peritoneal dialysis).

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Orange?

Yes, this clinical trial (NCT07207811) has an active research site in Orange, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Transthyretin Amyloid Cardiomyopathy (ATTR CM) Treatment Options in Orange, CA

If you're searching for transthyretin amyloid cardiomyopathy (attr cm) treatment options in Orange, CA, this clinical trial (NCT07207811) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Orange research site is actively enrolling participants for this clinical trial. You'll receive care from experienced transthyretin amyloid cardiomyopathy (attr cm) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all transthyretin amyloid cardiomyopathy (attr cm) clinical trials near you to find additional studies recruiting in your area.

Transthyretin Amyloid Cardiomyopathy (ATTR CM) Clinical Trial in Orange, CA

Expert Care in Orange

IRB Approved

No-Cost Care

Apply for This Orange Location

Why Participate?

Simple Process