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Heart health under the microscope: landmark study on Gender-Affirming hormones

NCT ID NCT07128771

Knowledge-focused Sponsor: University Hospital, Akershus 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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 450 people starting or continuing gender-affirming hormone therapy to see how it affects their heart and blood vessels over time. Researchers will use advanced heart scans, blood tests, and surveys to track changes. The goal is to provide clear information about cardiovascular risks and benefits to help patients and doctors make informed choices.

What this could mean

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

Active substance
gender-affirming hormone therapy
What this could lead to
If successful, this study could clarify whether gender-affirming hormone therapy is safe for the heart or increases cardiovascular risks, helping patients and doctors make informed decisions.
What could go wrong
This is an observational study, not a treatment trial, so it won't prove cause and effect. Results may take years and might not apply to everyone.

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

About 450 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Oct 2030

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.

Who is studied

Patients approved for gender-affirming hormone therapy by an endocrinologist at Oslo University Hospital.

Ages

16 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Diagnosis of gender-incongruence * Scheduled to initiate gender-affirming hormone therapy at Oslo University Hospital or currently being followed by an endocrinologist for gender-affirming hormone therapy at Oslo University Hospital * Being 16 years or older Exclusion Criteria: \- History of clinically significant cardiovascular disease For the healthy controls, these exclusion criteria also apply: * No daily smokers * No endocrine disorders * No daily medications (except contraception and seasonal medication such as antihistamines)

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder Gender Dysphoria heart disorder

As listed by the trial registrant

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

Cardiovascular disease (CVD) risk factors Gender incongruence

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Oslo University Hospital

    Oslo, Oslo, Norway

More trials for these conditions

Other studies related to the condition(s) this trial covers.