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Search / Trial NCT06372301

Dobutamine Stress Echocardiography in LF/LG Aortic Stenosis and Wild-type Transthyretin Amyloid Cardiomyopathy

Launched by STEEN HVITFELDT POULSEN · Apr 15, 2024

Trial Information

Current as of November 11, 2025

Recruiting

Keywords

Attr Cm Wild Type Cardiac Amyloidosis Aortic Stenosis Low Flow Low Gradient Aortic Stenosis Dobutamine

ClinConnect Summary

This clinical trial is studying how well a specific heart test called dobutamine stress echocardiography can help doctors understand the severity of aortic stenosis (a condition where the heart's aortic valve doesn’t open fully) in patients who also have wild-type transthyretin amyloid cardiomyopathy (a condition where protein builds up in the heart). The researchers want to find out if this test, which uses a medication to increase heart activity while taking ultrasound images, can provide accurate information compared to the standard method of measuring the aortic valve area directly from the heart.

To participate in this study, you must be at least 65 years old and have been diagnosed with wild-type transthyretin amyloid cardiomyopathy. You should be experiencing heart symptoms and currently be on diuretics (medications to help reduce fluid buildup). It’s important to note that the study will exclude those with other major heart valve problems or significant coronary artery disease. If you decide to join, you will undergo tests to assess your heart condition, including the dobutamine stress echocardiography, and the researchers will also look at heart tissue samples and other heart function measures. This trial is currently recruiting participants, and your involvement could help improve how doctors diagnose and treat these heart conditions in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. ATTRwt, diagnosis confirmed by 99mtc-3,3-Diphosphono-1,2-Propanodicarboxylic Acid (DPD) scintigraphy, genetic testing, and/or endomyocardial biopsy.
  • 2. Symptomatic patients (New York Heart Association \> class I) treated with loop diuretics.
  • 3. LF/LG AS: Defined as, aortic valve area ≤ 1 cm2 and mean gradient \< 40 mmHg, and SVI ≤35 ml/m2.
  • 4. Age ≥ 65 years.
  • 5. Oral and written informed consent.
  • Exclusion Criteria:
  • 1. Other significant valvular disease.
  • 2. Known severe coronary artery diseases: left main stem stenosis or 3-vessel disease, or recent acute myocardial infarction (\< 4 weeks).
  • 3. Contraindications to the use of dobutamine: Known allergy to dobutamine or sulfite, phaeochromocytoma or ventricular tachycardia (VT).

About Steen Hvitfeldt Poulsen

Steen Hvitfeldt Poulsen is a dedicated clinical trial sponsor focused on advancing medical research and innovation. With a commitment to ethical standards and patient safety, the organization collaborates with healthcare professionals and institutions to design, implement, and oversee clinical trials that explore new treatment modalities. By leveraging a robust network of expertise and resources, Steen Hvitfeldt Poulsen aims to contribute to the development of effective therapies and improve patient outcomes across various medical fields. Their mission is rooted in a passion for scientific excellence and a drive to enhance healthcare through rigorous research and development initiatives.

Locations

Aarhus, Denmark

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported