Is NCT07608354 recruiting in Jacksonville, FL?

Yes, NCT07608354 is currently recruiting participants at its Jacksonville, FL location. This transthyretin amyloid cardiomyopathy (attr-cm) clinical trial is actively enrolling qualified participants.

Is participation in this Jacksonville 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 Jacksonville, FL

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

To join this clinical trial in Jacksonville, 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 Jacksonville

The purpose of this randomised, double-blind, placebo-controlled, multicenter study is to evaluate the efficacy and safety of concomitant use of eplontersen and ALXN2220 compared with eplontersen and placebo in adult participants with Transthyretin-mediated amyloid cardiomyopathy (ATTR-CM).

Sponsor: AstraZeneca

Who Can Participate

Inclusion Criteria

Participant must be ≥ 18 years to ≤ 85 years at the time of signing the informed consent.

Participants who have a diagnosis of ATTR-CM with either wild-type or variant TTR genotype based on 1 of the following:

Endomyocardial biopsy with confirmatory TTR amyloid typing OR

Grade 2 or 3 cardiac uptake on 99mTc scintigraphy in the absence of monoclonal gammopathy OR

Grade 2 or 3 cardiac uptake on 99mTc scintigraphy AND confirmatory TTR amyloid typing in the presence of monoclonal gammopathy.

NYHA Class I to III at Screening and life expectancy of ≥ 1 year as per the Investigator's judgement.

End-diastolic IVST ≥ 12 mm on echocardiography.

NT-proBNP ≥ 600pg/mL for participants without ongoing atrial fibrillation/flutter at Screening or NT-proBNP ≥ 1200pg/mL for participants with ongoing atrial fibrillation/flutter at Screening.

Able to complete symptom-limited maximal CPET at Screening based on the following test criteria:

Able to exercise to near exhaustion during CPET as exhibited by RER ≥ 1.0 during symptom-limited CPET conducted during screening.

If participant does not achieve RER ≥1.0, the CPET may be repeated once, at least 48 hours but less than 2 weeks (but before randomization) after the initial test.

Treated according to locally recognised guidelines on standard-of-care treatment for patients with HF. Therapy should have been individually optimised and stable for ≥ 4 weeks (except diuretics) and include, unless contraindicated or not tolerated, treatment of high BP (targeting SBP \< 130 mmHg as suggested in 2022 American College of Cardiology/American Heart Association/Heart Failure Society of America HF guidelines), and ischaemic heart disease.

Willingness to adhere to daily self-administered vitamin A supplementation (3000 IU).

Exclusion Criteria

Known leptomeningeal amyloidosis.

Known light chain (AL) or secondary (amyloid A) amyloidosis, or any other form of systemic amyloidosis.

Cardiomyopathy not primarily caused by ATTR-CM, for example, cardiomyopathy primarily due to hypertension, valvular heart disease, or ischaemic heart disease per Investigator's assessment.

Acute coronary syndrome, unstable angina, stroke, transient ischaemic attack, coronary revascularisation, cardiac device implantation, cardiac valve repair, or major surgery within 12 weeks of Screening.

Uncontrolled hypertension (average resting SBP \> 160 mmHg or DBP \> 100 mmHg at Screening).

Average resting SBP \< 90 mmHg or symptomatic orthostatic hypotension, despite appropriate treatment, at Screening per Investigator's assessment.

Uncontrolled ventricular clinically significant cardiac arrhythmia, per Investigator's assessment.

Left ventricular ejection fraction \< 30% on echocardiography measured locally at Screening.

Severe pulmonary impairment (SpO₂ \< 92%) defined as resting SpO₂ below 92% on room air, measured by pulse oximetry, indicative of severe lung disease. Participants requiring supplemental oxygen to maintain SpO₂ ≥ 92%.

Participants with renal failure requiring dialysis.

History of solid organ transplantation or ventricular assist device or listing for heart transplantation at Screening. Note: prior history of planned corneal transplant is not an exclusion criterion.

Suspected or known intolerance/allergy to proteins or any components of the study intervention.

Any of the following results conducted at screening: i) Haemoglobin \<8g/dL for women or \<9g/dL for men. ii) Platelet count \<125 X10\*9/L or other disorder associated with clinically significant thrombocytopenia. iii) ALT \>2.0 X ULN iv) TBL \>2.5 X ULN (participants with known Gilbert's syndrome can be included with TBL \>2.5 X ULN as long as direct bilirubin is ≤ 1.5 X ULN) v) Serum retinol level \< LLN vi) By CKD-EPI formula, eGFR \<20 mL/min/1.73 m2 measured by the central laboratory at Screening.

Current unstable liver or biliary disease per Investigator's assessment.

Multiple myeloma, lymphoma, leukemia, or any malignancy or clonal stem cell disorder within the past 5 years (except basal cell or squamous epithelial carcinomas of the skin, melanoma in situ or cervical carcinoma in situ that have been curatively resected, Stage I cancer in remission, or adequately treated prostate cancer stage I, IIA, or IIB with Gleason score ≤ 3+4 and prostate-specific antigen \< 20 ng/mL).

Any prior treatment with an ATTR amyloid depleter or a TTR gene silencing agent approved or in clinical development.

Participated in a structured exercise training programme within the 1 month prior to Screening or planned to start during the trial.

Participation in another investigational clinical study or intake of another investigational drug within 30 calendar days or 5 half-lives of the IMP, whichever is longer before signing the ICF.

Judgement by the Investigator that the participant should not participate in the study if the participant has a known medical or psychological condition or other risk factor that might interfere with the participant's full participation in the study, pose any additional risk for the participant, or confound the assessment of the participant or outcome of the study.

Previous enrolment or randomisation in the present study.

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 Jacksonville?

Yes, this clinical trial (NCT07608354) has an active research site in Jacksonville, FL 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 Jacksonville, FL

If you're searching for transthyretin amyloid cardiomyopathy (attr-cm) treatment options in Jacksonville, FL, this clinical trial (NCT07608354) 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 Jacksonville 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 Jacksonville, FL

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