Improving Treatment Personalization of Pulmonary Hypertension Associated With Diastolic Heart Failure

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University of Illinois at Chicago
Sponsor:
Collaborator:
University of Illinois at Chicago
Information provided by (Responsible Party):
Julio Duarte, University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT02053246
First received: January 24, 2014
Last updated: September 29, 2014
Last verified: September 2014

January 24, 2014
September 29, 2014
January 2014
December 2016   (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 with PH associated with HFpEF. This project 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.

Not Provided
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
Experimental: Nebivolol
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
Not Provided
December 2016   (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
No
Contact: Julio Duarte, PharmD, PhD (312) 996-7440 juliod@uic.edu
United States
 
NCT02053246
2012-0824
No
Julio Duarte, University of Illinois at Chicago
Julio Duarte
University of Illinois at Chicago
Principal Investigator: Julio Duarte, PharmD, PhD University of Illinois at Chicago
University of Illinois at Chicago
September 2014

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