A randomized double-blind placebo controlled multi-center study to assess the effect of ranolazine on outcomes in subjects with pulmonary hypertension and right ventricular dysfunction accompanied by a comparative study of cellular metabolism in subjects with pulmonary hypertension with and without right ventricular dysfunction
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- STATUS
- Recruiting
Summary
A multi-center study evaluating the effects of ranolazine in subjects with class II/III/IV pulmonary hypertension on stable background therapy and persistent RV dysfunction. Study involves an observational arm and a 26-week treatment arm. At baseline (wk 0), interim (wk 13) and the conclusion of treatment period (wk 26) subjects will be assessed for functional class, 6- MWD, and QOL based on SF-36 tool. Subjects will be assessed with echo and peripheral blood will be obtained for metabolic profiling at baseline and the conclusion of the treatment period. Subjects will have baseline cardiac MRI done per standard of care or will have it done as part of the companion research imaging protocol. Subjects must enroll in companion imaging protocol to qualify for the treatment protocol.
Details
| Condition | Hypertension, pulmonary, pulmonary, hypertension |
|---|---|
| Age | 1years - 99years |
| Clinical Study Identifier | 817785 |
| Last Modified on | 19 February 2024 |
Eligibility
How to participate?
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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