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

NCT01932606 | Completed Phase 2 Results

• 1 other identifier: 13-004077
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Disease; Heart Failure With Preserved Ejection Fraction; Exercise Intolerance; Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• Exercise Pulmonary Capillary Wedge Pressure (PCWP)

  Pulmonary capillary wedge pressure (PCWP) provides an indirect estimate of left atrial pressure (LAP). PCWP is the pressure measured by wedging a pulmonary catheter with an inflated balloon into a small pulmonary arterial branch.

  during repeat exercise run, approximately 30 minutes after study drug administration

Secondary Outcomes (22)

• Change in Central Pressures After Study Drug (Resting)

  baseline, approximately 30 minutes after study drug administration

• Change in Heart Rate After Study Drug (Resting)

  baseline, approximately 30 minutes after study drug administration

• Change in Blood Pressure After Study Drug (Resting)

  baseline, approximately 30 minutes after study drug administration

• Change in Pulmonary Vascular Resistance (PVR) After Study Drug (Resting)

  baseline, approximately 30 minutes after study drug administration

• Change in Pulmonary Artery (PA) Compliance After Study Drug (Resting)

  baseline, approximately 30 minutes after study drug administration

Study Arms (2)

Nitrite

EXPERIMENTAL

Study drug (NaNO\_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.

Drug: Nitrite

Saline

PLACEBO COMPARATOR

Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.

Drug: Saline Placebo for Nitrite

Interventions

Nitrite DRUG

Study drug (NaNO\_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.

Nitrite

Saline Placebo for Nitrite DRUG

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).

Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 pulmonary capillary wedge pressure (PCWP)\>15 mmHg and/or PCWP≥25 mmHg during exercise)

You may not qualify if:

• Systolic BP \<120 mmHg
• Prior nitrate therapy (within previous 2 weeks)
• Glucose 6-phosphate dehydrogenase (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

Sponsors & Collaborators

• Barry Borlaug: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

• Borlaug BA, Koepp KE, Melenovsky V. Sodium Nitrite Improves Exercise Hemodynamics and Ventricular Performance in Heart Failure With Preserved Ejection Fraction. J Am Coll Cardiol. 2015 Oct 13;66(15):1672-82. doi: 10.1016/j.jacc.2015.07.067.

  PMID: 26449137 RESULT

• Reddy YNV, Stewart GM, Obokata M, Koepp KE, Borlaug BA. Peripheral and pulmonary effects of inorganic nitrite during exercise in heart failure with preserved ejection fraction. Eur J Heart Fail. 2021 May;23(5):814-823. doi: 10.1002/ejhf.2093. Epub 2021 Feb 1.

  PMID: 33421267 DERIVED

MeSH Terms

Conditions

Heart Diseases; Hypertension, Pulmonary

Interventions

Nitrites

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases

Intervention Hierarchy (Ancestors)

Anions; Ions; Electrolytes; Inorganic Chemicals; Nitrous Acid; Nitrogen Compounds; Organic Chemicals

Results Point of Contact

• Title: Dr. Barry A. Borlaug
• Organization: Mayo Clinic

Borlaug.Barry@mayo.edu

507-284-6704

Study Officials

• Barry Borlaug, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D., Associate Professor of Medicine

Study Record Dates

• First Submitted: August 27, 2013
• First Posted: August 30, 2013
• Study Start: August 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: March 14, 2016
• Results First Posted: February 15, 2016

Record last verified: 2016-02

Locations

US (1)