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Improving Treatment Personalization of Pulmonary Hypertension Associated With Diastolic Heart Failure

This study is currently recruiting participants.
Verified March 2017 by University of Florida
Sponsor:
ClinicalTrials.gov Identifier:
NCT02053246
First Posted: February 3, 2014
Last Update Posted: March 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
University of Florida
January 24, 2014
February 3, 2014
March 27, 2017
January 2014
December 2018   (Final data collection date for primary outcome measure)
Changes in pulmonary vascular pressure [ Time Frame: baseline - 18 weeks ]
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 ]
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
Intervention Model: Single Group Assignment
Masking: None (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)
  • 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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Julio Duarte, PharmD, PhD 352-273-8132 juliod@cop.ufl.edu
United States
 
 
NCT02053246
IRB201501144 -N
K23GM112014 ( U.S. NIH Grant/Contract )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
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 2017

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