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New combo therapy aims to tame heart sarcoidosis with fewer side effects

NCT ID NCT03593759

Disease control Sponsor: Ottawa Heart Institute Research Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Updated 2 times

Summary

This Phase 3 trial compares a low-dose combination of prednisone and methotrexate to standard high-dose prednisone for people with active cardiac sarcoidosis. Researchers hope the combo works just as well but causes fewer side effects and improves quality of life. The study plans to enroll 194 participants across multiple centers.

What this could mean

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

Active substance
prednisone or prednisolone combined with methotrexate
What this could lead to
If successful, this could offer a safer, equally effective treatment option for cardiac sarcoidosis, reducing side effects from high-dose steroids.
What could go wrong
This is a Phase 3 trial, but it's still relatively small (194 participants). The combination therapy may not be as effective as standard treatment, and both drugs have known risks like infection and liver toxicity.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 160 people

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

Started

Jan 2019

Expected to finish

Dec 2026

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

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: (i) Cardiac sarcoidosis presenting with one or more of the following clinical findings: * advanced conduction system disease (defined as Mobitz II AV block or third degree AV block) * significant sinus node dysfunction (defined as average HR less than 40bpm when awake and/or sustained atrial arrhythmias) * non- sustained or sustained ventricular arrhythmia * left ventricular dysfunction (LVEF \< 50%) * right ventricular dysfunction (RVEF \< 40%) AND (ii) No alternative explanation for clinical features AND (iii) Nuclear Imaging within six-months of enrollment consisting of FDG-PET scan with FDG uptake suggestive of active CS and myocardial perfusion imaging AND ONE OR BOTH OF FOLLOWING (iv) Positive biopsy for Sarcoid (either EMB or extra-cardiac) (v) CT Chest showing features consistent with pulmonary sarcoidosis and/or mediastinal and/or hilar lymphadenopathy Exclusion Criteria: 1. Current or recent (within two months) non-topical treatment for sarcoidosis 2. Current Oral/IV treatment of duration greater than 5 days 3. Currently taking Methotrexate or Prednisone for another health condition 4. Intolerance or contra-indication to Methotrexate or Prednisone 5. Patient does not meet all of the above listed inclusion criteria 6. Patient is unable or unwilling to provide informed consent 7. Patient is included in another randomized clinical trial 8. Patient has a contraindication to PET imaging or is unlikely to tolerate due to severe claustrophobia 9. Pregnancy (all women of child bearing age and potential will have a negative BHCG test before enrollment) 10. Breastfeeding 11. Women of childbearing age who refuse to use a highly effective and medically acceptable form of contraception throughout the study 12. Patients for whom the investigator believes that the trial is not in the interest of the patient

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Conditions

The condition(s) this trial relates to.

cardiac sarcoidosis sarcoidosis

As listed by the trial registrant

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

Cardiac sarcoidosis Sarcoidosis

How to take part

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

  1. The places running it

    31 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • Allegheny General Hospital

    RECRUITING

    Pittsburgh, Pennsylvania, 15212, United States

  • Auckland City Hospital

    RECRUITING

    Auckland, Grafton, 1023, New Zealand

  • CIUSSS de l'Estrie - CHUS - Hôpital Fleurimont

    RECRUITING

    Sherbrooke, Quebec, J1H 5N4, Canada

  • CIUSSS-Hopital du Sacre-Coeur de Montreal

    RECRUITING

    Montreal, Quebec, H4J 1C5, Canada

  • Chiba University

    RECRUITING

    Chiba, Japan

  • Eastern Health Health Sciences Centre

    RECRUITING

    St. John's, Newfoundland and Labrador, A1B 3V6, Canada

  • Hokkaido University

    RECRUITING

    Sapporo, Kita 8, Nishi 5, Kita-Ku, 060-0808, Japan

  • Imperial College Healthcare Trust-NHS-Hammersmith Hospital

    NOT_YET_RECRUITING

    London, W12 0HS, United Kingdom

  • Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval

    RECRUITING

    Québec, Quebec, G1V 4G5, Canada

  • King's College Hospital NHS Foundation Trust

    NOT_YET_RECRUITING

    London, SE5 9RS, United Kingdom

  • Libin Cardiovascular Institute of Alberta

    RECRUITING

    Calgary, Alberta, T2N 2T9, Canada

  • London Health Sciences Centre

    RECRUITING

    London, Ontario, N6A 4A5, Canada

  • Montefiore Medical Center

    RECRUITING

    New York, New York, 10467, United States

  • Montreal Heart Institute

    RECRUITING

    Montreal, Quebec, H1T 1C8, Canada

  • Nagoya City University

    RECRUITING

    Nagoya, Japan

  • National Cerebral and Cardiovascular Center (NCVC)

    RECRUITING

    Osaka, Japan

  • Nippon Medical School

    RECRUITING

    Tokyo, Japan

  • QE II Health Sciences Centre

    RECRUITING

    Halifax, Nova Scotia, B3H 3A7, Canada

  • Sapporo Medical University

    RECRUITING

    Sapporo, Japan

  • St. Joseph's Healthcare Centre

    RECRUITING

    Hamilton, Ontario, L8N 4A6, Canada

  • St. Marrianna University

    NOT_YET_RECRUITING

    Kawasaki, Japan

  • St. Paul's Hospital

    RECRUITING

    Vancouver, British Columbia, V5Z 1M9, Canada

  • The Ohio State University Wexner Medical Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Tufts Medical Center

    RECRUITING

    Boston, Massachusetts, 02111, United States

  • University of Fukui

    NOT_YET_RECRUITING

    Fukui, Japan

  • University of Michigan-Michigan Medicine Cardiovascular Center

    RECRUITING

    Ann Arbor, Michigan, 48109-5853, United States

  • University of Minnesota

    NOT_YET_RECRUITING

    Minneota, Minnesota, 55455, United States

  • University of Ottawa Heart Institute

    RECRUITING

    Ottawa, Ontario, K1Y 4W7, Canada

  • University of Utah

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • Virginia Commonwealth University

    RECRUITING

    Richmond, Virginia, 23298-0053, United States

  • Yale-New Haven Hospital

    RECRUITING

    New Haven, Connecticut, 06520, United States

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