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Heart surgery recovery study pulled before it began

NCT ID NCT06493123

Knowledge-focused Sponsor: Istanbul Saglik Bilimleri University 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 Results may not be published yet.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
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study was designed to see if early mobilization and a simple bottle-based breathing device (Bottle-P.E.P.) could improve breathing and physical function in people recovering from heart valve surgery. The trial was withdrawn before enrolling any participants, so no results are available. It would have included adults aged 25-75 who had valve surgery through a chest incision.

What this could mean

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

Active substance
Bottle-P.E.P. device (positive expiratory pressure therapy)

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Started

Apr 2024

Expected to finish

Jan 2025

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

25 to 75 years

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: * After heart valve surgery: Patients undergoing valvular surgery via sternotomy * Same surgical technique (from med-sternum) * Age group (25-75 Y) * Stable hemodynamic values (stable vital signs, normal temperature, etc.) * Full awareness of time and space Exclusion Criteria: * Ejection Fraction 35 % * Any Male/female patient \<25 or \>75 * Body Mass Index (BMI) ≥ 38 kg/m2 * Intubation time \>6 hours after surgery * Uncontrolled arrhythmias * Rheumatoid arthritis, other inflammatory and autoimmune diseases * Active malignancy * Cardiac pacemaker or defibrillator * Mental health disorders * Any postoperative complication (general muscle weakness, wound infection of the sternum or leg, stroke.) * Refusal to assist in data collection

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Conditions

The condition(s) this trial relates to.

heart valve disorder

As listed by the trial registrant

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

Heart valve diseases

Contacts and locations

Locations

  • Istanbul Provincial Health Directorate Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Education Research Hospital

    Istanbul, Uskudar, 34668, Turkey (Türkiye)

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