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A Phase 2, Double-blind, Randomized, Placebo-Controlled Study to Assess the Efficacy and Safety of TX000045 After 24 Weeks of Treatment in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (PH-HFpEF)
Status: Recruiting
This research study is testing a potential new treatment for pulmonary hypertension (high lung blood pressure due to heart failure) called TX000045 (study drug). Participants will be assigned to a study group and receive active study drug or a placebo (drug with no active ingredients). The study will last approximately 9 months
Sex: Male or Female
Age Group: 18 years and over
Inclusion Criteria:
• 18 Years to 83 years old
• male or female of non-childbearing potential
• diagnosis of Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (PH-HFpEF)
• Chronic medication for heart failure or cardiovascular disease is at a stable dose
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:
• started a new exercise program for cardiopulmonary rehabilitation or plans to initiate such a program during the study
• history or current evidence of a clinically significant disease or disorder such as significant lung disease, cardiovascular disease liver disease, infectious disease, or malignancy
• women who are pregnant or breastfeeding
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions:
Heart & Vascular
Keywords:
Clinics and Surgery Center (CSC), diagnosis of PH-HFpEF, Heart Failure, Pulmonary Hypertension
Study Contact: Gretchen Peichel - gpeichel@umn.edu
Principal Investigator: Thenappan Thenappan
Phase: PHASE2
IRB Number: STUDY00025446
See this study on ClinicalTrials.gov