Your session is about to expire
← Back to Search
Potassium Chloride for High Blood Pressure (PITCH Trial)
N/A
Recruiting
Led By Joshua D Bundy, PhD, MPH
Research Sponsored by Tulane University
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 12 weeks
Awards & highlights
PITCH Trial Summary
This trial will test how much potassium is needed to lower blood pressure in people with high blood pressure.
Who is the study for?
Adults over 18 with stage 1 hypertension (untreated systolic BP 130-139 and diastolic BP <90 mm Hg) can join. Excluded are those with certain medical conditions like heart failure, kidney disease, diabetes; high serum potassium or bicarbonate levels; heavy alcohol users; pregnant or breastfeeding women; and those on medications affecting potassium levels.Check my eligibility
What is being tested?
The PITCH study is examining how different amounts of potassium supplementation affect blood pressure in adults with stage 1 hypertension. Participants will receive either Potassium Chloride supplements or a placebo to determine the optimal level for lowering blood pressure.See study design
What are the potential side effects?
While not explicitly listed, potential side effects from Potassium Chloride may include stomach discomfort, diarrhea, nausea, vomiting, and high potassium levels which could lead to heart issues if not monitored.
PITCH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in 24-hour systolic blood pressure (BP) from baseline to 12 weeks
Secondary outcome measures
Change in 24-hour diastolic blood pressure (BP) from baseline to 12 weeks
Change in daytime (awake) diastolic blood pressure (BP) from baseline to 12 weeks
Change in daytime (awake) systolic blood pressure (BP) from baseline to 12 weeks
+4 morePITCH Trial Design
4Treatment groups
Active Control
Placebo Group
Group I: Potassium Chloride 90 mmol per dayActive Control1 Intervention
Participants randomized to the 90 mmol per day group will receive 3 potassium chloride tablets (15 mmol strength) twice daily (i.e., 6 tablets per day) for 12 weeks.
Group II: Potassium Chloride 60 mmol per dayActive Control1 Intervention
Participants randomized to the 60 mmol per day group will receive 2 potassium chloride tablets (15 mmol strength) twice daily (i.e., 4 tablets per day) for 12 weeks.
Group III: Potassium Chloride 30 mmol per dayActive Control1 Intervention
Participants randomized to the 30 mmol per day group will receive 1 potassium chloride tablet (15 mmol strength) twice daily (i.e., 2 tablets per day) for 12 weeks.
Group IV: PlaceboPlacebo Group1 Intervention
Participants randomized to the placebo arm will receive 1, 2, or 3 inert placebo tablets twice daily (i.e., 2, 4, or 6 tablets per day) for 12 weeks.
Find a Location
Who is running the clinical trial?
Tulane UniversityLead Sponsor
115 Previous Clinical Trials
226,278 Total Patients Enrolled
National Institute of General Medical Sciences (NIGMS)NIH
268 Previous Clinical Trials
248,679 Total Patients Enrolled
Joshua D Bundy, PhD, MPHPrincipal InvestigatorAssistant Professor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant, breastfeeding, nor planning to become pregnant during the study.I cannot take potassium supplements due to a serious health condition.I am not taking medication that affects my potassium levels.I am over 18 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Potassium Chloride 90 mmol per day
- Group 2: Potassium Chloride 60 mmol per day
- Group 3: Placebo
- Group 4: Potassium Chloride 30 mmol per day
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research currently enrolling new participants?
"Affirmative. Clinicaltrials.gov reveals that this clinical trial is actively searching for participants, having been initially posted on March 1st 2023 and subsequently revised on February 24th of the same year. A total of 224 individuals need to be recruited from a single site."
Answered by AI
What is the current enrollment for this experiment?
"Yes, according to clinicaltrials.gov, this medical trial is now enrolling patients and has been since March 1st 2023. This study was last modified on February 24th 2023 with the aim of recruiting 224 participants from a single centre."
Answered by AI
Share this study with friends
Copy Link
Messenger