Improving Treatment Personalization of Pulmonary Hypertension Associated With Diastolic Heart Failure
| Status: | Recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), High Blood Pressure (Hypertension), Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/13/2019 |
| Start Date: | January 2014 |
| End Date: | March 2020 |
| Contact: | Julio Duarte, PharmD, PhD |
| Email: | juliod@cop.ufl.edu |
| Phone: | 352-273-8132 |
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.
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.
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.
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.
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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