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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03015402
Recruitment Status : Active, not recruiting
First Posted : January 10, 2017
Last Update Posted : April 1, 2020
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Marc A. Simon, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE January 5, 2017
First Posted Date  ICMJE January 10, 2017
Last Update Posted Date April 1, 2020
Actual Study Start Date  ICMJE October 30, 2017
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2017)
Pulmonary artery pressure (mPAP) during submaximal exercise as compared between placebo and nitrite [ Time Frame: 10 weeks (i.e. the 10th week of placebo vs 10th week of nitrite). ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 6, 2017)
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). ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2017)
  • Difference in 6-minute walk test [ Time Frame: 10 weeks (i.e. the 10th week of placebo vs 10th week of nitrite) ]
    Assessed using Borg dyspnea scale
  • Change in right heart catheterization (RHC) hemodynamics [ Time Frame: 10 weeks (i.e. the 10th week of placebo vs 10th 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: 10 weeks (i.e. the 10th week of placebo vs 10th week of nitrite) ]
    Determined by NT-proBNP plasma levels
  • Change in endurance exercise time [ Time Frame: 10 weeks (i.e. the 10th week of placebo vs 10th week of nitrite) ]
  • Change in severity of heart failure [ Time Frame: 10 weeks (i.e. the 10th week of placebo vs 10th week of nitrite) ]
    Determined by NYHA functional classification changes
Original Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2017)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oral Nitrite in Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction
Official Title  ICMJE Phase II Clinical Investigation of Oral Nitrite in Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction (PH-HFpEF)
Brief Summary 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).
Detailed Description This is a single-center, 22-week double-blind, randomized placebo-controlled cross-over trial of oral nitrite on exercise capacity and hemodynamic measurements in subjects with PH-HFpEF.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Pulmonary Hypertension Secondary
  • Heart Failure
Intervention  ICMJE
  • Drug: Sodium Nitrite
    40 mg PO (by mouth) TID (three times each day) for 10 weeks
  • 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 10 weeks
Study Arms  ICMJE
  • Experimental: Sodium Nitrite
    Intervention: Drug: Sodium Nitrite
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo Oral Capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: January 6, 2017)
26
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Age 18 years and older

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03015402
Other Study ID Numbers  ICMJE PRO16110594
5P01HL103455 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marc A. Simon, University of Pittsburgh
Study Sponsor  ICMJE Gladwin, Mark, MD
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Marc A Simon, MD, MS, FACC University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date March 2020

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