Improving Treatment Personalization of Pulmonary Hypertension Associated With Diastolic Heart Failure

Phase 4TerminatedNCT02053246

University of Florida11 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pulmonary Hypertension Diastolic Heart Failure Heart Failure With Preserved Ejection Fraction

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Changes in Pulmonary Vascular Pressure

Difference between baseline and 18 week mean pulmonary artery pressure and pulmonary artery wedge pressure

Time frame: baseline - 18 weeks

Secondary Outcomes

Changes in 6-minute Walk Distance

Difference in 6-minute walk distance between baseline and 18 weeks.