Cardiac Sarcoidosis Randomized Trial
A legfontosabb adatok
- Hol
- Ann Arbor, Boston, Columbus, Minneota, New Haven, New York, Pittsburgh, Richmond és Salt Lake City (Egyesült Államok)Mind a 9 helyszín megnézése
- Fázis
- 3. fázis
Helyszínek itt: Egyesült Államok
- University of Michigan-Michigan Medicine Cardiovascular CenterAnn Arbor, Egyesült ÁllamokContact: Todd Koelling, MDRésztvevőt keres
- Tufts Medical CenterBoston, Egyesült ÁllamokContact: Mili Mehta, MDRésztvevőt keres
- The Ohio State University -Wexner Medical CenterColumbus, Egyesült ÁllamokContact: Steven Kalbfleisch, MDRésztvevőt keres
- University of MinnesotaMinneota, Egyesült ÁllamokContact: C Shenoy, MDToborzás még nem indult
- Yale New Haven HospitalNew Haven, Egyesült ÁllamokContact: Edward Miller, MDRésztvevőt keres
- Montefiore Medical CenterNew York, Egyesült ÁllamokContact: Yogita Rochlani, MDRésztvevőt keres
- Allegheny General HospitalPittsburgh, Egyesült ÁllamokContact: Indu Poornima, MDRésztvevőt keres
- Virginia Commonwealth UniversityRichmond, Egyesült ÁllamokContact: Jordana Kron, MDRésztvevőt keres
- University of UtahSalt Lake City, Egyesült ÁllamokContact: Line Kemeyou, MDRésztvevőt keres
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Ottawa Heart Institute Research Corporation
- Azonosító
- NCT03593759
- A regiszteradat frissítve
- 2026. július 10.
- Eredeti leírás
Prospective randomized controlled trial comparing low dose Prednisone(or Prednisolone)/Methotrexate combination to standard dose Prednisone(or Prednisolone) in patients diagnosed with acute active clinically manifest cardiac sarcoidosis and not yet treated.A teljes eredeti leírásKevesebb
Cardiac Sarcoidosis Multi-Center Randomized Controlled Trial
Prospective randomized controlled trial comparing low dose Prednisone(or Prednisolone)/Methotrexate combination to standard dose Prednisone(or Prednisolone) in patients diagnosed with acute active clinically manifest cardiac sarcoidosis and not yet treated.
The Investigators hypothesize that low dose Prednisone(or Prednisolone)/Methotrexate combination will be as effective as standard dose Prednisone(or Prednisolone), and result in significantly better quality of life and less toxicity than standard dose Prednisone(or Prednisolone).
Bevonási feltételek: (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.
Kizáró feltételek: Currently taking Methotrexate or Prednisone for another health condition; Pregnancy (all women of child bearing age and potential will have a negative BHCG test before enrollment); Women of childbearing age who refuse to use a highly effective and medically acceptable form of contraception throughout the study; Current or recent (within two months) non-topical treatment for sarcoidosis; Current Oral/IV treatment of duration greater than 5 days; Intolerance or contra-indication to Methotrexate or Prednisone; Patient does not meet all of the above listed inclusion criteria; Patient is unable or unwilling to provide informed consent; Patient is included in another randomized clinical trial; Patient has a contraindication to PET imaging or is unlikely to tolerate due to severe claustrophobia; Breastfeeding; Patients for whom the investigator believes that the trial is not in the interest of the patient.