Improving Treatment Personalization of Pulmonary Hypertension Associated With Diastolic Heart Failure

Pulmonary Hypertension Clinical Trial

Official title:

Improving Treatment Personalization of Pulmonary Hypertension Associated With Diastolic Heart Failure

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02053246
• Other study ID #: IRB201501144 -N
• Secondary ID: K23GM112014
• Status: Terminated
• Phase: Phase 4
• Start date: January 2014
• Est. completion date: March 2021

Study information

• Verified date: January 2022
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: March 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diastolic Heart Failure
• Heart Failure
• Heart Failure With Preserved Ejection Fraction
• Heart Failure, Diastolic
• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

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

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Pulmonary Vascular Pressure	Difference between baseline and 18 week mean pulmonary artery pressure and pulmonary artery wedge pressure	baseline - 18 weeks
Secondary	Changes in 6-minute Walk Distance	Difference in 6-minute walk distance between baseline and 18 weeks.	baseline - 18 weeks