The Effect of Potassium Nitrate [KNO3] on Exercise Capacity in Heart Failure Patients.

The Effect of Potassium Nitrate [KNO3] on Exercise Capacity in Heart Failure Patients.
Recruiting
18 years - 90 years
All
Phase 2
47 participants needed
1 Location

Brief description of study

This study will test whether Potassium Nitrate (KNO3) will improve how people with HFpEF [Diastolic Heart Failure] can exercise. In HFpEF, patients are limited in their ability to do all the things they want to do, and exercise as much as they would like, due to becoming tired and short of breath early. We do not know exactly why these limitations occur. There is some evidence that in addition to problems with the heart, patients with HFpEF also have problems with their arteries and muscles that affect their ability to exercise. Potassium Nitrate has been shown to improve how muscles work and also improve blood flow to working muscles in the body in healthy individuals. We previously conducted a pilot study with our KNO3 pills and found them to be safe in subjects with HFpEF. We would like to now study our pills in a large study to see if we can improve exercise in HFpEF. The use of Potassium Nitrate in this study is experimental. Potassium Nitrate has not been approved by the Food and Drug Administration (FDA) for the use being evaluated in this study.

Detailed description of study

If you decide to participate, you will be asked to come to the research center for 3 study visits and 2 MRI visits.Visit 1 confirms that you are a good candidate for our study. It will include baseline labs, questionnaires, arterial tonometry [non-invasive technique to measure pressure in the arteries], a resting echocardiogram, and a Six-Minute Walk Test. You will be mailed drug A [either KNO3 or placebo] and will begin taking it. You will come back 6 weeks later to the research center for visit 2 which includes labs, resting echocardiogram, arterial tonometry, MRI scan, and a maximal effort bike test. You will then be mailed drug B [either KNO3 or placebo] and will begin taking it. You will come back 6 weeks later to the research center for the 3rd and final visit. This includes the same testing as visit 2.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Heart failure,Diastolic Heart Failure,heart failure,diastolic congestive heart failure (diagnosis),diastolic CHF,Diastolic (congestive) heart failure,diastolic congestive heart failure,diastolic congestive heart failure (diagnosis),Diastolic (congestive) heart failure,class II left-sided congestive heart failure,class III left-sided congestive heart failure (diagnosis)
  • Age: 18 years - 90 years
  • Gender: All
Updated on 19 Feb 2024. Study ID: 824290

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