โšกYour ready-to-use recruitment solution: IRB-compliant, SEO-optimized website that automatically routes qualified patient leads to your clinical study (14-day free trial, then $44/mo)

NCT05489523RECRUITINGIRB Ready

Safety, Efficacy, and Pharmacokinetics of Tafamidis in Patients With Transthyretin-mediated Amyloidosis Post Orthotopic Heart Transplantation

Sponsored by University of Texas Southwestern Medical Center

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
๐Ÿ“Š
1 of 25 participants interested
4% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

Transthyretin cardiac amyloidosis (ATTR-CA) is a relentlessly progressive disease that can progress to end stage heart failure, at which point recently approved transthyretin production silencing or structure stabilizing therapies provide no clinical benefit. For well-selected individuals, heart transplantation is an excellent therapeutic option to improve survival.

Who Can Participate

Inclusion Criteria

Has received orthotopic heart transplantation for end-stage ATTRv or ATTRwt โ‰ฅ12 months prior to screening. Concomitant hepatic and renal transplantation with adequate allograft function are included.
Has a stable immunosuppressive regimen and โ‰ค 10 mg of prednisone (or equivalent) at time of enrollment.
Has a Karnofsky performance status โ‰ฅ 70%

Exclusion Criteria

Has previously received inotersen within the past 180 days, patisiran within the past 90 days, tafamidis within the past 14 days, or diflunisal in the past 14 days.
Participating in a clinical trial for ATTR targeted therapies.
Has an estimated glomerular filtration rate (eGFR) โ‰ค 15 ml/min/1.73 m2
Has known leptomeningeal or AL amyloidosis
Has active post-transplant lymphoproliferative disease
Excluding non-melanomatous skin cancers, has an active malignancy.
Has active infection with hepatitis B, hepatitis C, human immunodeficiency virus, or cytomegalovirus (CMV). For CMV, donor/ reci

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

๐Ÿ“‹

Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

25 participants

๐ŸŽ‚

Age Range

18 Years - 90 Years

โšง

Gender

ALL

๐Ÿข

Sponsor

University of Texas Southwestern Medical Center

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Beverly Hills

California

Location available
View Beverly Hills location page
RECRUITING

New York

New York

Location available
View New York location page
RECRUITING

Cleveland

Ohio

Location available
View Cleveland location page
RECRUITING

Dallas

Texas

Location available
View Dallas location page

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

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

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

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

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Transthyretin Amyloidosis Treatment in Beverly Hills?

Join others in California exploring innovative treatment options through clinical research

Transthyretin Amyloidosis Treatment Options in Beverly Hills, California

If you're searching for Transthyretin Amyloidosis treatment in Beverly Hills, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Beverly Hills, New York, Cleveland and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Transthyretin Amyloidosis. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 25 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Transthyretin Amyloidosis?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Transthyretin Amyloidosis

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Transthyretin Amyloidosis Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05489523. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.