Improving Treatment Personalization of Pulmonary Hypertension Associated With Diastolic Heart Failure

• Status: Completed
• Trial end date: 2021-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Collaborator: National Institute of General Medical Sciences (NIGMS)
• Treatments: Nebivolol

Criteria

Inclusion Criteria:

• Adults (≥ 18 years of age) with World Health Organization Group 2 Pulmonary Hypertension (Mean pulmonary artery pressure ≥ 25 mmHg and pulmonary capillary wedge pressure ≥ 15 mmHg)

• New York Heart Association class II-IV symptoms

• Left ventricular ejection fraction (LVEF) ≥ 45%

Exclusion Criteria:

• Other causes of heart failure other than diastolic dysfunction, such as restrictive cardiomyopathy or infiltrative cardiomyopathy

• Women who are pregnant or nursing

• Liver cirrhosis,

• Primary valvular disease

• Acute coronary syndrome

• Causes of PH other than that of heart failure, such as: chronic thromboembolic PH, sickle-cell disease, or sarcoidosis

• Severe bradycardia or greater than 1st degree heart block

• Decompensated heart failure

• Current use of a third generation beta-blocker (nebivolol, carvedilol, or labetalol) or high dose of any beta-blockers (greater than 100 mg daily of metoprolol, or equivalent)