Pharmacological Reduction of Right Ventricular Enlargement (PROVE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04345796|
Recruitment Status : Not yet recruiting
First Posted : April 14, 2020
Last Update Posted : July 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Tricuspid Regurgitation Right Ventricular Dilatation||Drug: Carvedilol+Empagliflozin Drug: Carvedilol Drug: Empagliflozin Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Factorial Assignment|
|Intervention Model Description:||2 x 2 factorial|
|Masking:||Single (Outcomes Assessor)|
To study efficacy of carvedilol, participants will be assigned to a carvedilol or to placebo and the identity of the treatment will be concealed by the use of study drugs that are identical in packaging, labeling, appearance and odor. Participants allocated to the SGLT2 inhibitor arm will receive empagliflozin 10mg.
All imaging studies will be analyzed by core laboratory investigators who will be blinded to treatment assignment from the time of randomization until database lock.
|Official Title:||Multicenter, Randomized, 2 x 2 Factorial, Phase 3 Study to Assess the Efficacy of Carvedilol and Empagliflozin on Improvement of Right Ventricular Remodeling in Patients With Severe Functional Tricuspid Regurgitation|
|Estimated Study Start Date :||August 2020|
|Estimated Primary Completion Date :||May 2023|
|Estimated Study Completion Date :||May 2023|
Active Comparator: carvedilol+empagliflozin
Patients will receive carvedilol SR 16mg and empagliflozin 10mg qd.
Other Name: Dilatrend SR+Jardiance
Active Comparator: carvedilol alone
Patients will receive carvedilol SR 16mg alone.
Other Name: Dilatrend SR
Active Comparator: empagliflozin alone
Patients will receive empagliflozin 10mg and matching placebo of carvedilol.
Other Name: Jardiance
Placebo Comparator: placebo
Patients will receive matching placebo of carvedilol.
Other Name: Matching placebo of Dilatrend SR
- Change of RV end-systolic volume index [ Time Frame: from baseline to 12 months follow-up ]Change of RV end-systolic volume index by cardiac MRI
- Change of RV end-diastolic volume index [ Time Frame: from baseline to 12 months follow-up ]Change of RV end-diastolic volume index by cardiac MRI
- Change of RV ejection fraction [ Time Frame: from baseline to 12 months follow-up ]Change of RV ejection fraction by cardiac MRI
- Change of vena contract width of TR [ Time Frame: from baseline to 12 months follow-up ]Change of vena contract width of TR by echocardiography
- Occurrences of death from cardiovascular causes or hospitalization for heart failure [ Time Frame: the entire follow-up period (continuing until 12 months after the last patient was enrolled) ]Clinical outcome
- Occurrences of death from any causes [ Time Frame: the entire follow-up period (continuing until 12 months after the last patient was enrolled) ]Clinical outcome
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04345796
|Contact: DUK HYUN KANG, MDfirstname.lastname@example.org|
|Korea, Republic of|
|Asan Medical Center|
|Seoul, Korea, Republic of, 138-736|
|Samsung Medical Center|
|Seoul, Korea, Republic of|
|Seoul National University Hospital|
|Seoul, Korea, Republic of|
|Principal Investigator:||DUK HYUN KANG||Asan Medical Center|