Inorganic Nitrite to Amplify the Benefits and Tolerability of Exercise Training in Heart Failure With Preserved Ejection Fraction (HFpEF) (INABLE-Training)

  • STATUS
    Recruiting
  • End date
    Dec 24, 2021
  • participants needed
    100
  • sponsor
    Barry Borlaug
Updated on 24 January 2021
hypertension
edema
ejection fraction
heart failure
cardiac rehabilitation
rehabilitation program
dyspnea
pulmonary congestion
congestion
nesiritide
b-type natriuretic peptide
natriuretic peptide
diastolic dysfunction
heart failure with preserved ejection fraction

Summary

Participants with heart failure with preserved ejection fraction will undergo 12 weeks of cardiac rehabilitation for exercise training (ET) and be randomized to either oral sodium nitrite capsules or oral placebo capsules through the training period. Study drug is administered 3 times daily during daytime hours with one of these doses being 30 minutes prior to onset of ET sessions throughout the12 week trial. The objective is to determine if the oral sodium nitrite improves the clinical responses and tolerability of ET.

Details
Condition Heart failure, Heart disease, Congestive Heart Failure, Cardiac Disease, cardiac failure, congestive heart disease
Treatment Placebo solution, Sodium Nitrite Inhalation Solution, Accelerometer, Cardiac Exercise Training, Oral Sodium Nitrite
Clinical Study IdentifierNCT02713126
SponsorBarry Borlaug
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 40 yrs?
Gender: Male or Female
Do you have any of these conditions: Heart disease or Cardiac Disease or Congestive Heart Failure or Heart failure?
Do you have any of these conditions: cardiac failure or congestive heart disease or Heart failure or Heart disease or Cardiac Disease or Congestive Heart Failure?
Age 40 years
Symptoms of dyspnea (II-IV) without evidence of a non-cardiac or ischemic explanation for dyspnea
Ejection Fraction (EF) of > or = 50% determined on most recent imaging study within the preceding 5 years, with no change in clinical status suggesting potential for deterioration in systolic function
One of the following
Previous hospitalization for Heart Failure (HF) with radiographic evidence (pulmonary venous hypertension, vascular congestion, interstitial edema, pleural effusion) of pulmonary congestion or
Catheterization documented elevated filling pressures at rest (Pulmonary Capillary Wedge Pressure (PCWP)= 15 or Left Ventricular End-Diastolic Pressure (LVEDP) 18) or with exercise (PCWP 25) or
Elevated Natruretic Peptide-proBNP (>400 pg/ml) or B-Type Natriuretic Peptide (BNP)(>200 pg/ml) or
Echo evidence of diastolic dysfunction/elevated filling pressures manifest by medial E/e' ratio15 and/or left atrial enlargement and chronic treatment with a diuretic for signs or symptoms of heart failure
Heart failure is primary factor limiting activity as indicated by answering # 2 to the following question
My ability to be active is most limited by
Joint, foot, leg, hip or back pain
Shortness of breath and/or fatigue and/or chest pain
Unsteadiness or dizziness
Lifestyle, weather, or I just don't like to be active
No chronic nitrate therapy or not using intermittent sublingual nitroglycerin (requirement for >1 sublingual nitroglycerin per week)
No daily use of phosphodiesterase 5 (PDE5) inhibitors or soluble guanylyl cyclase activators and willing to withhold as needed use of PDE5 inhibitors for duration of study
Ambulatory (not wheelchair / scooter dependent)
Body size allows wearing of the accelerometer belt as confirmed by ability to comfortably fasten the test belt provided for the screening process
Willingness to wear the accelerometer belt for the duration of the trial

Exclusion Criteria

Recent (< 1 month) hospitalization for heart failure
Ongoing requirement for PDE5 inhibitor, organic nitrate or soluble guanylyl cyclase activators
Hemoglobin (Hgb) < 8.0 g/dl within 30 days prior to randomization
Glomerular Filtration Rate (GFR) < 20 ml/min/1.73 m2 within 30 days prior to randomization
Systolic blood pressure < 115 mmHg seated or < 90 mmHg standing
Resting Heart Rate > 110
Previous adverse reaction to the study drug which necessitated withdrawal of therapy
Significant chronic obstructive pulmonary disease that is a primary contributor to symptoms, in the opinion of the Investigator
Ischemia thought to contribute to dyspnea, in the opinion of the Investigator
Documentation of previous Ejection Fraction < 40%
Acute coronary syndrome within 3 months defined by electrocardiographic (ECG) changes and biomarkers of myocardial necrosis (e.g., troponin) in an appropriate clinical setting (chest discomfort or anginal equivalent)
Percutaneous Coronary Intervention, coronary artery bypass grafting, or new biventricular pacing within past 3 months
Obstructive hypertrophic cardiomyopathy
Known infiltrative cardiomyopathy (amyloid)
Constrictive pericarditis or tamponade
Active myocarditis
Complex congenital heart disease
Active collagen vascular disease
More than mild aortic or mitral stenosis
Intrinsic (prolapse, rheumatic) valve disease with more than moderate mitral, tricuspid or aortic regurgitation
Acute or chronic severe liver disease as evidenced by any of the following: encephalopathy, variceal bleeding, International Normalized Ratio (INR) > 1.7 in the absence of anticoagulation treatment
Terminal illness (other than HF) with expected survival of less than 1 year
Enrollment or planned enrollment in another therapeutic clinical trial in next 3 months
Inability to comply with planned study procedures
Pregnancy or breastfeeding mothers
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