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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: February 15, 2016
Last verified: February 2016
Results First Received: January 15, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Heart Disease
Heart Failure With Preserved Ejection Fraction
Exercise Intolerance
Pulmonary Hypertension
Interventions: Drug: Nitrite
Drug: Saline Placebo for Nitrite

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were enrolled in the trial between January and September 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Nitrite Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
Placebo Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.

Participant Flow:   Overall Study
    Nitrite     Placebo  
STARTED     14     14  
COMPLETED     14     14  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Nitrite Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
Placebo Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
Total Total of all reporting groups

Baseline Measures
    Nitrite     Placebo     Total  
Number of Participants  
[units: participants]
  14     14     28  
Age  
[units: years]
Mean (Standard Deviation)
  69  (6)     70  (8)     69  (8)  
Gender  
[units: participants]
     
Female     9     8     17  
Male     5     6     11  
Region of Enrollment  
[units: participants]
     
United States     14     14     28  



  Outcome Measures
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1.  Primary:   Exercise Pulmonary Capillary Wedge Pressure (PCWP)   [ Time Frame: during repeat exercise run, approximately 30 minutes after study drug administration ]

2.  Secondary:   Change in Central Pressures After Study Drug (Resting)   [ Time Frame: baseline, approximately 30 minutes after study drug administration ]

3.  Secondary:   Change in Heart Rate After Study Drug (Resting)   [ Time Frame: baseline, approximately 30 minutes after study drug administration ]

4.  Secondary:   Change in Blood Pressure After Study Drug (Resting)   [ Time Frame: baseline, approximately 30 minutes after study drug administration ]

5.  Secondary:   Change in Pulmonary Vascular Resistance (PVR) After Study Drug (Resting)   [ Time Frame: baseline, approximately 30 minutes after study drug administration ]

6.  Secondary:   Change in Pulmonary Artery (PA) Compliance After Study Drug (Resting)   [ Time Frame: baseline, approximately 30 minutes after study drug administration ]

7.  Secondary:   Change in Systemic Vascular Resistance (SVR) After Study Drug (Resting)   [ Time Frame: baseline, approximately 30 minutes after study drug administration ]

8.  Secondary:   Change in Left Ventricular Stroke Work (LVSW) After Study Drug (Resting)   [ Time Frame: baseline, approximately 30 minutes after study drug administration ]

9.  Secondary:   Change in Oxygen Consumption (VO_2) After Study Drug (Resting)   [ Time Frame: baseline, approximately 30 minutes after study drug administration ]

10.  Secondary:   Change in Arteriovenous Oxygen Content Difference After Study Drug (Resting)   [ Time Frame: baseline, approximately 30 minutes after study drug administration ]

11.  Secondary:   Change in Cardiac Output After Study Drug (Resting)   [ Time Frame: baseline, approximately 30 minutes after study drug administration ]

12.  Secondary:   Change in Stroke Volume After Study Drug (Resting)   [ Time Frame: baseline, approximately 30 minutes after study drug administration ]

13.  Secondary:   Change in Central Pressures After Study Drug (Exercise)   [ Time Frame: baseline, approximately 30 minutes after study drug administration ]

14.  Secondary:   Change in Heart Rate After Study Drug (Exercise)   [ Time Frame: baseline, approximately 30 minutes after study drug administration ]

15.  Secondary:   Change in Blood Pressure After Study Drug (Exercise)   [ Time Frame: baseline, approximately 30 minutes after study drug administration ]

16.  Secondary:   Change in PVR After Study Drug (Exercise)   [ Time Frame: baseline, approximately 30 minutes after study drug administration ]

17.  Secondary:   Change in PA Compliance After Study Drug (Exercise)   [ Time Frame: baseline, approximately 30 minutes after study drug administration ]

18.  Secondary:   Change in SVR After Study Drug (Exercise)   [ Time Frame: baseline, approximately 30 minutes after study drug administration ]

19.  Secondary:   Change in LVSW After Study Drug (Exercise)   [ Time Frame: baseline, approximately 30 minutes after study drug administration ]

20.  Secondary:   Change in Oxygen Consumption (VO_2) After Study Drug (Exercise)   [ Time Frame: baseline, approximately 30 minutes after study drug administration ]

21.  Secondary:   Change in Arteriovenous Oxygen Difference After Study Drug (Exercise)   [ Time Frame: baseline, approximately 30 minutes after study drug administration ]

22.  Secondary:   Change in Cardiac Output After Study Drug (Exercise)   [ Time Frame: baseline, approximately 30 minutes after study drug administration ]

23.  Secondary:   Change in Stroke Volume After Study Drug (Exercise)   [ Time Frame: baseline, approximately 30 minutes after study drug administration ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Barry A. Borlaug
Organization: Mayo Clinic
phone: 507-284-6704
e-mail: Borlaug.Barry@mayo.edu


Publications of Results:

Responsible Party: Barry Borlaug, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01932606     History of Changes
Other Study ID Numbers: 13-004077
Study First Received: August 27, 2013
Results First Received: January 15, 2016
Last Updated: February 15, 2016
Health Authority: United States: Food and Drug Administration