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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
  Purpose
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.

Condition Intervention Phase
Pulmonary Hypertension Diastolic Heart Failure Heart Failure With Preserved Ejection Fraction Drug: Nebivolol Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Treatment Personalization of Pulmonary Hypertension Associated With Diastolic Heart Failure

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Changes in pulmonary vascular pressure [ Time Frame: baseline - 18 weeks ]

Secondary Outcome Measures:
  • Changes in 6-minute walk distance [ Time Frame: baseline - 18 weeks ]

Estimated Enrollment: 40
Study Start Date: January 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02053246


Contacts
Contact: Julio Duarte, PharmD, PhD 352-273-8132 juliod@cop.ufl.edu

Locations
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32611
Contact: Julio Duarte, PharmD, PhD    352-273-8132    juliod@cop.ufl.edu   
Sponsors and Collaborators
University of Florida
National Institute of General Medical Sciences (NIGMS)
Investigators
Principal Investigator: Julio Duarte, PharmD, PhD University of Florida
  More Information

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02053246     History of Changes
Other Study ID Numbers: IRB201501144 -N
K23GM112014 ( U.S. NIH Grant/Contract )
First Submitted: January 24, 2014
First Posted: February 3, 2014
Last Update Posted: March 27, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Diastolic
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Lung Diseases
Respiratory Tract Diseases
Nebivolol
Antihypertensive Agents
Vasodilator Agents
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs