Improving Treatment Personalization of Pulmonary Hypertension Associated With Diastolic Heart Failure

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by University of Florida
Sponsor:
Collaborator:
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT02053246
First received: January 24, 2014
Last updated: March 4, 2016
Last verified: March 2016

January 24, 2014
March 4, 2016
January 2014
December 2018   (final data collection date for primary outcome measure)
Changes in pulmonary vascular pressure [ Time Frame: baseline - 18 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT02053246 on ClinicalTrials.gov Archive Site
Changes in 6-minute walk distance [ Time Frame: baseline - 18 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Improving Treatment Personalization of Pulmonary Hypertension Associated With Diastolic Heart Failure
Improving Treatment Personalization of Pulmonary Hypertension Associated With Diastolic Heart Failure
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.
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pulmonary Hypertension
  • Diastolic Heart Failure
  • Heart Failure With Preserved Ejection Fraction
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.
Experimental: 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.
Intervention: Drug: Nebivolol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2018
December 2018   (final data collection date for primary outcome measure)

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)
  • A diagnosis of heart failure by a University of Illinois cardiologist
  • 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
  • Active smokers,
  • 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 renal insufficiency (patient on hemodialysis or serum creatinine > 2.5 mg/dl)
  • 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)
Both
18 Years and older   (Adult, Senior)
No
Contact: Julio Duarte, PharmD, PhD 352-273-8132 juliod@cop.ufl.edu
United States
 
NCT02053246
IRB201501144, K23GM112014
No
Undecided
Not Provided
University of Florida
University of Florida
National Institute of General Medical Sciences (NIGMS)
Principal Investigator: Julio Duarte, PharmD, PhD University of Florida
University of Florida
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP