Phase 2
N=15
Oral Nitrite for Older Heart Failure With Preserved Ejection Fraction
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT02918552 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Cardiorespiratory Fitness — 4.1; 4.0; 5.1; 4.5 ml/kg/min
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- sodium nitrite (Drug); Control (Drug)
- Age
- Older Adult · 70+ yrs
- Sex
- All
- Sponsor
- Gladwin, Mark, MD
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cardiorespiratory Fitness |
4.1; 4.0; 5.1; 4.5; 18.6; 19.0 | — |
| SECONDARY Perceived Fatigability |
9.1; 10.8; 8.3; 10.3; -1.2; -0.2 | — |
| SECONDARY Bioenergetics: In-Vivo 31P MRS Respirations |
.028; .019; .028; .022 | — |
| SECONDARY Bioenergetics: Ex-Vivo Mitochondrial Respiration Analysis |
34.6; 57.7; 61.6; 46.0; 27.1; -11.7 | — |
| SECONDARY Exercise-induced Changes in Pulmonary Arterial Pressure |
11.0; 16.0; 17.5; 15.3; 28.5; 41.7 | — |
| SECONDARY Exercise-induced Changes in Pulmonary Capillary Wedge Pressure |
5.5; 8.3; 8.5; 5.7; 11.0; 22.7 | — |
| SECONDARY Patients With Pulmonary Hypertension |
0; 0 | — |
| SECONDARY Steps From Accelerometry Assessment of Daily Activity |
58399; 54122; 48741; 53757; -9657; -366 | — |
| SECONDARY Sedentary Events From Accelerometry Assessment of Daily Activity |
29.7; 24.0; 23.7; 24.7; -6.0; 0.7 | — |
| SECONDARY Light Activity Duration From Accelerometry Assessment of Daily Activity |
3288; 3317; 2866; 3224; -422; -94 | — |
| SECONDARY Moderate to Vigorous Physical Activity From Accelerometry Assessment of Daily Activity |
719.3; 545.8; 507.8; 548.2; -211.5; 2.333 | — |
| SECONDARY Vector Magnitude Counts From Accelerometry Assessment of Daily Activity |
1192.5; 1205; 1043; 1122.7; -149.4; -82.3 | — |
| SECONDARY Sedentary Event Duration From Accelerometry Assessment of Daily Activity |
14.8; 13.6; 14.4; 12.0; -0.4; -1.6 | — |
| SECONDARY Light Activity Events Percentage of Day From Accelerometry Assessment of Daily Activity |
.320; .359; .306; .359; -0.014; -0.033 | — |
| SECONDARY Moderate to Vigorous Physical Activity Percentage From Accelerometry Assessment of Daily Activity |
0.066; 0.059; 0.054; 0.055; -0.012; -0.004 | — |
Summary
This is a randomized double blinded controlled trial of 20-40 mg sodium nitrite tid in subjects with HFpEF. Primary outcomes are measures of physical function with non-invasive and invasive cardiopulmonary exercise testing, and fatigability, skeletal muscle bioenergetics, serology including inflammatory markers and platelet bioenergetics, quality of life measures.
Eligibility Criteria
Inclusion Criteria
- Age ≥70 years
- Diagnosis of HFpEF [adapted from the 2016 European Society of Cardiology (ESC) Guidelines to include:
- Prior diagnosis of HF via one of these:
- medical record diagnosis by attending cardiologist
- verbal confirmation of HFpEF with attending cardiologist
- PI review of medical record to confirm HFpEF AND 2. Ejection Fraction % ≥40
- Clinically stable (euvolemic; baseline heart rate 180/95 or 10.0
- Other chronic unstable disease such as active neoplasm, end stage chronic kidney, liver or other organ disease,
Data sourced from ClinicalTrials.gov (NCT02918552). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.