NCT02053246

Improving Treatment Personalization of Pulmonary Hypertension Associated With Diastolic Heart Failure

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Heart failure with preserved ejection fraction (HFpEF), is one of the leading causes of pulmonary hypertension (PH). Despite the severity of this disease, no established treatments exist for this class of PH. Nebivolol is a drug used in high blood pressure and heart failure, but not used in patients with PH. Due to some additional properties it possesses, the investigators believe nebivolol will improve disease severity in patients with PH associated with HFpEF. The hypothesis of this research study is that nebivolol improves PH severity in patients with HFpEF, as measured by hemodynamic and clinical parameters.

Detailed description

This research study will be a prospective, open-label 18-week clinical study of nebivolol in patients with PH associated with HFpEF. Patients will be identified in clinic based on echocardiogram (TTE) and right heart catheterization (RHC) results (both part of standard clinical care) indicating PH and HFpEF.

Conditions

• Pulmonary Hypertension
• Diastolic Heart Failure
• Heart Failure With Preserved Ejection Fraction

Interventions

Type	Name	Description
DRUG	Nebivolol	Nebivolol will be started at 2.5 mg by mouth daily if on a beta-blocker the dose will start at 5mg, and titrated up to 10 mg daily, as tolerated.

Timeline

• Start date: 2014-01-01
• Primary completion: 2021-03-01
• Completion: 2021-03-01
• First posted: 2014-02-03
• Last updated: 2022-02-10
• Results posted: 2022-02-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study