Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Oral Nitrite in Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction (PH-HFpEF)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2017 by University of Pittsburgh
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Marc A. Simon, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT03015402
First received: January 5, 2017
Last updated: January 6, 2017
Last verified: January 2017
  Purpose
The main objective of this study is to determine the clinical efficacy of oral inorganic nitrite verses placebo and the therapeutic response with regards to exercise tolerance in patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF).

Condition Intervention Phase
Pulmonary Hypertension Secondary
Heart Failure
Drug: Sodium Nitrite
Drug: Placebo Oral Capsule
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II Clinical Investigation of Oral Nitrite in Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction (PH-HFpEF)

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Pulmonary artery pressure (mPAP) during submaximal exercise as compared between placebo and nitrite [ Time Frame: 12 weeks (i.e. the 12th week of placebo vs 12th week of nitrite). ]

Secondary Outcome Measures:
  • Difference in 6-minute walk test [ Time Frame: 12 weeks (i.e. the 12th week of placebo vs 12th week of nitrite) ]
    Assessed using Borg dyspnea scale

  • Change in right heart catheterization (RHC) hemodynamics [ Time Frame: 12 weeks (i.e. the 12th week of placebo vs 12th week of nitrite) ]
    RHC hemodynamic measures will be aggregated to determine if overall hemodynamic are improved over the course of treatment

  • Change in severity of heart failure [ Time Frame: 12 weeks (i.e. the 12th week of placebo vs 12th week of nitrite) ]
    Determined by NT-proBNP plasma levels

  • Change in endurance exercise time [ Time Frame: 12 weeks (i.e. the 12th week of placebo vs 12th week of nitrite) ]
  • Change in severity of heart failure [ Time Frame: 12 weeks (i.e. the 12th week of placebo vs 12th week of nitrite) ]
    Determined by NYHA functional classification changes


Estimated Enrollment: 26
Study Start Date: June 2017
Estimated Primary Completion Date: March 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sodium Nitrite Drug: Sodium Nitrite
40 mg PO (by mouth) TID (three times each day) for 3 months
Placebo Comparator: Placebo Drug: Placebo Oral Capsule
Placebo capsule that is of identical size, shape, and color to experimental drug capsule PO (by mouth) TID (three times each day) for 3 months

Detailed Description:
This is a single-center, 26-week double-blind, randomized placebo-controlled cross-over trial of oral nitrite on exercise capacity and hemodynamic measurements in subjects with PH-HFpEF.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Age 18 years and older

Screening blood pressure (BP) with either systolic or diastolic over stated level baseline BP ≤ 170/95

PH-HFpEF confirmed diagnosis by RHC:

  • Mean Pulmonary Arterial Pressure (mPAP) ≥ 25 mmHg AND
  • Pulmonary capillary wedge pressure (PWCP) ≥ 15 mmHg AND
  • Transpulmonary Gradient (TPG) ≥ 12 mmHg

Exclusion Criteria:

  • Age less than 18 years;
  • SBP > 170 or < 110 mmHg
  • DBP >95 or < 60 mmHg
  • Hemoglobin A1C > 10
  • Positive urine pregnancy test or breastfeeding;
  • Ejection Fraction (EF) < 40%;
  • Dementia
  • End-stage malignancy
  • Major cardiovascular event or procedure within 6 weeks prior to enrollment
  • Severe valvular disease
  • Known chronic psychiatric or medical conditions that may increase the risk associated with study participation in the judgment of the investigator, would make the subject inappropriate for entry into this study;
  • Smoker
  • Hemoglobin <9 g/dL
  • Serum creatinine > 3.0 mg/dL
  • Receipt of an investigational product or device, or participation in a drug research study within a period of 15 days; RHC < 2 weeks from study screening RHC unless clinically indicated
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03015402

Contacts
Contact: Nicole L Helbling, RN, BSN, MS 412-692-2285 helblingnl@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Nicole L Helbling, RN, BSN, MS    412-692-2285    helblingnl@upmc.edu   
Sponsors and Collaborators
University of Pittsburgh
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Marc A Simon, MD, MS, FACC University of Pittsburgh
  More Information

Responsible Party: Marc A. Simon, Associate Professor of Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03015402     History of Changes
Other Study ID Numbers: PRO16110594
5P01HL103455 ( US NIH Grant/Contract Award Number )
Study First Received: January 5, 2017
Last Updated: January 6, 2017

Additional relevant MeSH terms:
Hypertension
Heart Failure
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 24, 2017