Heart Failure Clinical Trial
Improving Treatment Personalization of Pulmonary Hypertension Associated With Diastolic Heart Failure
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.
Full 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.
Eligibility 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)
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There is 1 Location for this study
Gainesville Florida, 32611, United States
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