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Potassium Nitrate (KNO3) for Heart Failure
Phase 2
Waitlist Available
Led By Payman Zamani, MD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks after start of phase 1 (experimental drug or control); 6 weeks after start of phase 2 (experimental drug or control)
Awards & highlights
Study Summary
This study is evaluating whether a drug which is used to treat angina may help improve exercise capacity in heart failure patients.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks after start of phase 1 (experimental drug or control); 6 weeks after start of phase 2 (experimental drug or control)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks after start of phase 1 (experimental drug or control); 6 weeks after start of phase 2 (experimental drug or control)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Total Work Performed During a Maximal-effort Exercise Test From Phase 1 to Phase 2
Difference in Peak Oxygen Consumption (Vo2) Between KNO3 and KCl Phases
Secondary outcome measures
Effect of KNO3 on the Percent Change of Systemic Vasodilatory Response to Exercise: The Change in Systemic Vascular Resistance Reserve During Exercise During a Maximal Effort Exercise Test
Effect of Potassium Nitrate (KNO3) on Arterial Wave Reflections as Assessed by Wave Separation Analysis Using Tonometry and Doppler Flow Data
Effect of Potassium Nitrate (KNO3) on Augmentation Index
+8 moreSide effects data
From 2022 Phase 2 trial • 84 Patients • NCT0284079921%
other
19%
stomach ache
14%
fatigue
10%
headache
9%
shortness of breath
8%
nausea
6%
swelling
4%
palpitations
4%
chest pain
4%
weakness
3%
vomiting
3%
bilateral knee pain
3%
insomnia
3%
shortness of breath during the peak exercise test
3%
gassiness
3%
fatigue during the peak exercise test
3%
diarrhea
1%
oral thrush
1%
rapid heart beat
1%
sore throat
1%
cough
1%
bronchitis
1%
skin irritation
1%
edema
1%
fever
1%
hypoglycemic episode
1%
creatinine increase
1%
lightheadedness
1%
positive orthostat
1%
aches in the joints
1%
leg cramps
1%
restlessness
1%
thigh cramps
1%
abnormal sensation of swallowing
1%
soreness
1%
dizziness
1%
hip pain
1%
o2 desaturation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Potassium Nitrate (KNO3)
Potassium Chloride (KCl)
Baseline Visit
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Potassium Nitrate (KNO3)Experimental Treatment1 Intervention
Potassium nitrate (KNO3) capsules, providing 6 millimoles of inorganic nitrate per capsule, to be taken three times daily for 6 weeks.
Group II: Potassium Chloride (KCl)Placebo Group1 Intervention
Potassium Chloride (KCl) is the placebo (control drug) in this trial.
Potassium Chloride (KCl) capsules administered at a dose of 6 millimoles (1 capsule) three times daily for 6 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Potassium Nitrate (KNO3)
2016
Completed Phase 2
~90
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,005 Previous Clinical Trials
42,882,125 Total Patients Enrolled
42 Trials studying Heart Failure
7,430 Patients Enrolled for Heart Failure
Northwestern UniversityOTHER
1,586 Previous Clinical Trials
916,897 Total Patients Enrolled
20 Trials studying Heart Failure
4,219 Patients Enrolled for Heart Failure
Julio A Chirinos, MD, PhDStudy ChairUniversity of Pennsylvania
3 Previous Clinical Trials
61 Total Patients Enrolled
2 Trials studying Heart Failure
61 Patients Enrolled for Heart Failure
Frequently Asked Questions
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