Tilt Table vs Recorder Study for Fainting

(STUTTER Trial)

No longer recruiting at 1 trial location

Overseen By Roopinder Sandhu, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Informed consent, Follow up, Carotid sinus

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the better approach for diagnosing fainting spells: a head-up tilt table, which tilts participants upright to observe bodily reactions, or an implantable loop recorder, a small device placed under the skin to monitor heart rhythms. Participants will be randomly assigned to one of these methods to identify which leads to a quicker diagnosis. Individuals who have experienced unexplained fainting in the past year, with no cause identified through basic tests, may be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to medical knowledge and potentially achieve a quicker diagnosis for the condition.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these syncope therapies are safe?

Previous studies have found the Head Up Tilt Table (HUT) test to be quite safe, even for older individuals. Fewer than 6% of patients experienced mostly minor unwanted effects. The test involves tilting a person to observe their body's reaction, which can help identify the cause of fainting.

Research has shown that the Implantable Loop Recorder (ILR) is also safe. This small device, placed under the skin, monitors heart rhythms. Studies indicate that it neither harms the heart nor alters heart rates. It assists doctors in determining if a heart rhythm issue is causing fainting.

Both the HUT and ILR are well-tolerated and have undergone safety testing in people. For those considering joining a trial, these treatments have strong safety records. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Tilt Table vs Recorder approach for managing fainting because it explores two distinct methods that could lead to better diagnosis and management. The Head Up Tilt Table (HUT) test provides immediate insights by simulating conditions that might cause fainting, helping doctors understand triggers in real-time. On the other hand, the Implantable Loop Recorder continuously monitors heart rhythms over a longer period, potentially catching irregularities that might be missed in a clinical setting. This trial aims to determine which method offers more reliable and timely information, potentially leading to more personalized and effective care for patients prone to fainting.

What evidence suggests that this trial's treatments could be effective for diagnosing syncope?

This trial will compare two strategies for diagnosing fainting: the Head Up Tilt Table (HUT) test and the Implantable Loop Recorder (ILR). Research has shown that the HUT test effectively identifies the cause of fainting in about two-thirds of cases, with a sensitivity of around 65.9% in individuals who faint. One study found that using nitroglycerin during the test helps diagnose 47% of patients with heart-related fainting. Meanwhile, the ILR effectively diagnoses fainting episodes, detecting or ruling out serious heart rhythm problems in more than half of the patients. This device is particularly useful when other tests have not provided answers, as it can reveal hidden heart issues that might cause fainting. Participants in this trial will be randomly assigned to receive either the HUT test or the ILR. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for people aged 50 or older who have fainted in the last year and still don't know why, even after a physical exam and heart rhythm test. They shouldn't be at high risk of dying from the fainting, able to agree to participate, and can come back for check-ups.

Inclusion Criteria

You are not at risk of dying from fainting.

I have had fainting episodes in the last year.

My diagnosis is still uncertain after basic tests.

Exclusion Criteria

I am unable to understand and give consent for treatment.

I cannot go to regular check-ups at the clinic.

You have had a positive carotid sinus massage.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either early Head-Up Tilt Table procedure or early Implantable Loop Recorder

1 week

1 visit (in-person) for ILR implantation or HUT procedure

Follow-up

Participants are monitored for diagnosis and safety, with follow-up visits every 6 months

3 years

Biannual visits (in-person) and additional visits after symptomatic events

What Are the Treatments Tested in This Trial?

Interventions

• Head Up Tilt Table (HUT)
• Implantable Loop Recorder

Trial Overview The study is comparing two standard ways to figure out why someone faints: using a tilt table that changes their position or putting in a tiny device under the skin that records heart activity over time.

How Is the Trial Designed?

Group I: All eligible participants Experimental Treatment 2 Interventions

All eligible participants are randomly assigned to one of two interventions- early Head-Up Tilt Table procedure or early Implantable Loop Recorder. The assignment is random and at a 1:1 ratio between the two strategies.

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0019483225000604

A contemporary review of the head-up tilt test: Utility and ... HUTT has been shown to be safe in an older population, long-term outcomes are benign even when relatively aggressive protocols are used. HUTT is a cost- ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12223533/

A contemporary review of the head-up tilt test: Utility and ... When HUTT is performed with NTG provocation, a positive response is seen in 47 % of patients with cardiac syncope, 33 %–35 % with unexplained ...

3. academic.oup.com academic.oup.com/ageing/article/54/4/afaf086/8109891

Head-up tilt testing in older syncope patients - Oxford Academic There is no consistent evidence that HUTT results differ between older and younger syncope patients. Nitroglycerin-HUTT yields the most ...

4. frontiersin.org frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2021.781157/full

Clinical Features of Patients Undergoing the Head-Up Tilt ... Among the patients in the syncope group, the sensitivity of the HUTT was 65.9%, which was significantly higher than a sensitivity of 44.8% for ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC80733/

The fainting patient: value of the head-upright tilt-table test in ... Axelrod and coworkers tilted 10 patients with familial dysautonomia at an angle of 90° for 5 minutes and had positive results in all cases. Ward and Kenny ...

6. my.clevelandclinic.org my.clevelandclinic.org/health/diagnostics/17043-tilt-table-test

What a Tilt Table Test Can Show A tilt table test shows how your body responds to standing up after lying down. This test helps providers find the cause of your fainting.