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Improving Treatment Personalization of Pulmonary Hypertension Associated With Diastolic Heart Failure

Primary Purpose

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

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Nebivolol
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • University of Florida

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nebivolol

Arm 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.

Outcomes

Primary Outcome Measures

Changes in Pulmonary Vascular Pressure
Difference between baseline and 18 week mean pulmonary artery pressure and pulmonary artery wedge pressure

Secondary Outcome Measures

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

Full Information

First Posted
January 24, 2014
Last Updated
January 19, 2022
Sponsor
University of Florida
Collaborators
National Institute of General Medical Sciences (NIGMS)
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1. Study Identification

Unique Protocol Identification Number
NCT02053246
Brief Title
Improving Treatment Personalization of Pulmonary Hypertension Associated With Diastolic Heart Failure
Official Title
Improving Treatment Personalization of Pulmonary Hypertension Associated With Diastolic Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Terminated
Why Stopped
Study funding ended before recruitment completed.
Study Start Date
January 2014 (Actual)
Primary Completion Date
March 2021 (Actual)
Study Completion Date
March 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Institute of General Medical Sciences (NIGMS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension, Diastolic Heart Failure, Heart Failure With Preserved Ejection Fraction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nebivolol
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Nebivolol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Pulmonary Vascular Pressure
Description
Difference between baseline and 18 week mean pulmonary artery pressure and pulmonary artery wedge pressure
Time Frame
baseline - 18 weeks
Secondary Outcome Measure Information:
Title
Changes in 6-minute Walk Distance
Description
Difference in 6-minute walk distance between baseline and 18 weeks.
Time Frame
baseline - 18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julio Duarte, PharmD, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Improving Treatment Personalization of Pulmonary Hypertension Associated With Diastolic Heart Failure

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