Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Acute Effects of Inorganic Nitrite on Cardiovascular Hemodynamics in Heart Failure With Preserved Ejection Fraction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Barry Borlaug, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01932606
First received: August 27, 2013
Last updated: November 25, 2014
Last verified: November 2014

August 27, 2013
November 25, 2014
August 2013
October 2014   (final data collection date for primary outcome measure)
Exercise pulmonary capillary wedge pressure [ Time Frame: during repeat exercise run, approximately 30 minutes after study drug administration ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01932606 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Acute Effects of Inorganic Nitrite on Cardiovascular Hemodynamics in Heart Failure With Preserved Ejection Fraction
Acute Effects of Inorganic Nitrite on Cardiovascular Hemodynamics in Heart Failure With Preserved Ejection Fraction

Heart failure with preserved ejection fraction (HFpEF) is a major public health problem that has no proven effective treatment. This study will assess the effects of acute nitrite administration on resting and exercise hemodynamics in patients with HFpEF referred to the catheterization lab.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Heart Disease
  • Heart Failure With Preserved Ejection Fraction
  • Exercise Intolerance
  • Pulmonary Hypertension
  • Drug: Nitrite
    Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
  • Drug: Saline Placebo for Nitrite
    Normal saline placebo will be infused for 5 minutes during the cardiac catheterization procedure. Hemodynamics will then be measured at baseline after study drug infusion and again during low level exercise (20 Watts).
  • Experimental: Nitrite
    Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
    Intervention: Drug: Nitrite
  • Placebo Comparator: Saline
    Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
    Intervention: Drug: Saline Placebo for Nitrite
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
October 2014
October 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Scheduled to undergo a cardiac catheterization procedure.
  • Clinical symptoms of shortness of breath and fatigue
  • Normal left ventricular ejection fraction (≥50%)
  • Elevated left ventricular filling pressures at cardiac catheterization (defined as resting PCWP>15 mmHg and/or PCWP≥25 mmHg during exercise)

Exclusion Criteria:

  • Systolic BP <120 mmHg
  • Prior nitrate therapy (within previous 2 weeks)
  • G6PD-deficiency
  • Other "non-HFpEF" specific causes of heart failure such as significant valvular disease (>moderate left-sided regurgitation, >mild stenosis), severe pulmonary disease, unstable coronary disease or coronary spasm, primary renal or hepatic disease, constrictive pericarditis, or infiltrative, restrictive, or hypertrophic cardiomyopathies
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01932606
13-004077
No
Barry Borlaug, Mayo Clinic
Barry Borlaug
Not Provided
Principal Investigator: Barry Borlaug, MD Mayo Clinic
Mayo Clinic
November 2014

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