Improving Treatment Personalization of Pulmonary Hypertension Associated With Diastolic Heart Failure

Phase 4

Terminated

• Conditions: Heart Failure With Preserved Ejection Fraction; Pulmonary Hypertension; Diastolic Heart Failure
• Interventions: Drug: Nebivolol

• Registration Number: NCT02053246
• Lead Sponsor: University of Florida

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-24
• Study First Submitted QC: 2014-01-30
• Study First Posted: 2014-02-03
• Primary Completion: 2021-03
• Study Completion: 2021-03
• Status Verified: 2022-01
• Results First Submitted: 2022-01-19
• Results First Submitted QC: 2022-01-19
• Last Update Submitted: 2022-01-19
• Results First Posted: 2022-02-10
• Last Update Posted: 2022-02-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nebivolol	Nebivolol	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.

Primary Outcome Measures

Name	Time	Method
Changes in Pulmonary Vascular Pressure	baseline - 18 weeks	Difference between baseline and 18 week mean pulmonary artery pressure and pulmonary artery wedge pressure

Secondary Outcome Measures

Name	Time	Method
Changes in 6-minute Walk Distance	baseline - 18 weeks	Difference in 6-minute walk distance between baseline and 18 weeks.

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States