Improving Treatment Personalization of Pulmonary Hypertension Associated With Diastolic Heart Failure

University of Florida

Status and phase: Terminated; Phase 4

Conditions: Diastolic Heart Failure; Heart Failure With Preserved Ejection Fraction; Pulmonary Hypertension

Treatments: Drug: Nebivolol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02053246

K23GM112014 (U.S. NIH Grant/Contract)

IRB201501144 -N

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Nebivolol

Experimental group

Description:

Participants will be started at 2.5 mg of nebivolol by mouth daily if on a beta-blocker the dose will start at 5mg, and titrated up to 10 mg daily, as tolerated.

Treatment:

Drug: Nebivolol