Oral Nitrite in Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction

  • STATUS
    Recruiting
  • End date
    Mar 28, 2022
  • participants needed
    26
  • sponsor
    Gladwin, Mark, MD
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Updated on 28 January 2021
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ejection fraction
heart failure with preserved ejection fraction

Summary

The main objective of this study is to determine the clinical efficacy of oral inorganic nitrite verses placebo and the therapeutic response with regards to exercise tolerance in patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF).

Description

This is a single-center, 22-week double-blind, randomized placebo-controlled cross-over trial of oral nitrite on exercise capacity and hemodynamic measurements in subjects with PH-HFpEF.

Details
Condition Heart failure, Heart disease, Pulmonary Hypertension Secondary, Congestive Heart Failure, Cardiac Disease, cardiac failure, secondary pulmonary hypertension, congestive heart disease
Treatment Placebo oral capsule, sodium nitrite
Clinical Study IdentifierNCT03015402
SponsorGladwin, Mark, MD
Last Modified on28 January 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Cardiac Disease or Pulmonary Hypertension Secondary or Congestive Heart Failure or Heart failure or Heart disease?
Do you have any of these conditions: secondary pulmonary hypertension or Heart disease or Cardiac Disease or Heart failure or cardiac failure or Congestive Heart Failure or Pulmonary Hype...?
Do you have any of these conditions: Pulmonary Hypertension Secondary or Congestive Heart Failure or Cardiac Disease or cardiac failure or congestive heart disease or secondary pulmonary ...?
Do you have any of these conditions: Cardiac Disease or Congestive Heart Failure or Pulmonary Hypertension Secondary or secondary pulmonary hypertension or cardiac failure or congestive h...?
Do you have any of these conditions: secondary pulmonary hypertension or cardiac failure or Heart disease or Pulmonary Hypertension Secondary or Cardiac Disease or Congestive Heart Failur...?
Do you have any of these conditions: cardiac failure or secondary pulmonary hypertension or Congestive Heart Failure or Heart disease or congestive heart disease or Heart failure or Pulmo...?
Age 18 years and older
PH-HFpEF confirmed diagnosis by RHC
Mean Pulmonary Arterial Pressure (mPAP) 25 mmHg AND
Pulmonary capillary wedge pressure (PWCP) 15 mmHg AND
Transpulmonary Gradient (TPG) 12 mmHg

Exclusion Criteria

Age less than 18 years
SBP > 170 or < 110 mmHg
DBP >95 or < 60 mmHg
Hemoglobin A1C > 10
Positive urine pregnancy test or breastfeeding
Ejection Fraction (EF) < 40%
Dementia
End-stage malignancy
Major cardiovascular event or procedure within 6 weeks prior to enrollment
Severe valvular disease
Known chronic psychiatric or medical conditions that may increase the risk associated with study participation in the judgment of the investigator, would make the subject inappropriate for entry into this study
Smoker
Hemoglobin <9 g/dL
Serum creatinine > 3.0 mg/dL
Receipt of an investigational product or device, or participation in a drug research study within a period of 15 days; RHC < 2 weeks from study screening RHC unless clinically indicated
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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