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Hidden heart condition: study seeks to uncover missed diagnosis in heart failure patients

NCT ID NCT06338839

Knowledge-focused Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study aims to find out how common transthyretin amyloidosis cardiomyopathy (ATTR-CM) is in Russian patients with a certain type of heart failure. Researchers will review medical records and then invite some patients for extra heart tests to confirm or rule out ATTR-CM. The goal is to better understand this underdiagnosed condition in real-world medical practice.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help doctors better identify a hidden cause of heart failure, leading to earlier diagnosis and more targeted care.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly help patients. It was also terminated early, which may limit the data collected.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

1,770 people

The number who actually took part.

Started

Dec 2023

Finished

Jun 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Planned study population consists of approximately 6000 patients with HFpEF who are participating/participated in the PRIORITY-CHF study and will be enrolled to this study across 140 clinical centers in different regions of Russia, in order to provide a representative study sample. Those patients who have a high suspicion of having ATTR-CM and provided informed consent will be invited to participate in the prospective phase. The patients will be included to the current study consecutively, from the earliest date of start of participation in the PRIORITY-CHF study.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: for the retrospective phase are: * Patients participating/participated in the PRIORITY-CHF study (may be alive or deceased at the time of inclusion to this study). * Established diagnosis of HFpEF (presence of typical signs and symptoms of HF (see Appendix A) and LVEF ≥50%) at any time during participation in the PRIORITY-CHF study. The following criteria apply for inclusion of patients into the prospective part of the study: * Provided written informed consent for the prospective phase of the study. * Presence of left ventricular wall thickness \>12 mm. * Presence of at least three of "red flags" or additional signs for having high-risk of ATTR-CM (evaluation based on medical history of HF and concomitant diseases, family history, results of previous ECG, Echo-CG/cardiac MRI, laboratory data): * \>65 age (during participation in the PRIORITY-CHF study) * Conduction system disease (atrioventricular block, left bundle branch block, long QRS complex, sick sinus syndrome)/pacemaker * Atrial fibrillation * Pseudoinfarct pattern on the ECG (when hemodynamically significant stenosis is absent); * Disproportion of QRS voltage to the degree of increased LV wall thickness on imaging methods * Grade 2 or worse diastolic dysfunction * Decreased longitudinal strain with apical sparing * Diffuse subendocardial or transmural late gadolinium enhancement on cardiac MRI with increased extracellular volume fraction * Persistent low-level troponin elevation * Elevated NT-proBNP level * Right ventricular (RV) wall thickness more than 6 mm * Pericardial effusion in patients with LV-hypertrophy * Restrictive pattern in patients with LV-hypertrophy * Atrial enlargement with the normal ventricular volumes * Bilateral carpal tunnel syndrome * Lumbar/cervical spinal stenosis * Spontaneous biceps tendon rupture * Hip or knee replacement * Peripheral neuropathy * Family history of neuropathy * Intolerance/poor tolerance to vasodilating antihypertensive medications * Orthostatic hypotension * Gastroparesis * Urinary incontinence (neurogenic bladder), recurrent urinary infections, * Erectile dysfunction * Other autonomic dysfunction, such as gastrointestinal motility disorders (constipation, early satiety, chronic diarrhea, nausea/vomiting), syncope, anhidrosis) Exclusion Criteria: Exclusion criteria for the retrospective phase are: * Any severe condition that, in opinion of the physician, will limit patient's life span to 12 months or less from the inclusion to this study. * Current participation in any interventional trial (i.e. at the time of inclusion to this study). The following criteria apply for exclusion of patients from the prospective part of the study: * Patients with previously established (and documented) ATTR-CM. * Patients with previous positive hematological test result on evaluating AL-amyloidosis in the anamnesis (monoclonal protein is identified by SIFE/UIF) and the serum FLC ratio (kappa/lambda) is in outside of the normal range). If the hematological test on evaluating AL amyloidosis is negative, or there is no such test performed in the patient's medical history, the patient may be enrolled to this study.

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Conditions

The condition(s) this trial relates to.

ATTRV122I amyloidosis diastolic heart failure wild type ATTR amyloidosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Transthyretin amyloidosis cardiomyopathy, heart failure with preserved ejection fraction

Contacts and locations

Locations

  • Research Site

    Akhtubinsk, Russia

  • Research Site

    Astrakhan, Russia

  • Research Site

    Barnaul, Russia

  • Research Site

    Beslan, Russia

  • Research Site

    Chelyabinsk, Russia

  • Research Site

    Izhevsk, Russia

  • Research Site

    Kaluga, Russia

  • Research Site

    Kazan', Russia

  • Research Site

    Khabarovsk, Russia

  • Research Site

    Kirov, Russia

  • Research Site

    Krasnodar, Russia

  • Research Site

    Nizhny Novgorod, Russia

  • Research Site

    Omsk, Russia

  • Research Site

    Rostov-on-Don, Russia

  • Research Site

    Smolensk, Russia

  • Research Site

    Ufa, Russia

  • Research Site

    Vladimir, Russia

  • Research Site

    Vladivostok, Russia

  • Research Site

    Volgograd, Russia

  • Research Site

    Yaroslavl, Russia

  • Research Site

    Yekaterinburg, Russia

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