Trials / Completed
CompletedNCT01932606
Acute Effects of Inorganic Nitrite on Cardiovascular Hemodynamics in Heart Failure With Preserved Ejection Fraction
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- Barry Borlaug · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Subjects were studied on their long-term medications in the post-absorptive state and supine position. Right heart catheterization was performed with simultaneous expired gas analysis at rest and during supine exercise at a 20 Watts workload for 5 minutes. After the first exercise phase (before any drug administration) and after return to steady-state baseline hemodynamic values, subjects were randomized. Study drug or placebo was infused for 5 minutes. After a 10 minute observation period, hemodynamic measurements were repeated at rest, followed by repeat supine exercise at a 20 Watts workload for 5 minutes, identical to the study's first phase. Arterial and venous blood samples and hemodynamic and expired gas data were acquired during each stage of the protocol.
Conditions
- Heart Disease
- Heart Failure With Preserved Ejection Fraction
- Exercise Intolerance
- Pulmonary Hypertension
Interventions
| Type | Name | Description |
|---|---|---|
| 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). |
Timeline
- Start date
- 2013-08-01
- Primary completion
- 2014-10-01
- Completion
- 2014-10-01
- First posted
- 2013-08-30
- Last updated
- 2016-03-14
- Results posted
- 2016-02-15
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01932606. Inclusion in this directory is not an endorsement.