Immediate Pressor Response to Oral Salt

High Blood Pressure Clinical Trial

— IPROS  

Official title:

Diagnostic Accuracy of Using an Immediate Pressor Response to Oral Salt (IPROS) to Identify Salt Sensitivity of Blood Pressure (SSBP): a Time Series Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06226636
• Other study ID #: IPROS
• Status: Recruiting
• Phase: N/A
• Start date: July 7, 2023
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: Mulungushi University
• Contact: Sepiso K Masenga, PhD
• Phone: +260977674774
• Email: sepisomasenga[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to establish a diagnostic accuracy of an immediate pressor response to oral salt (IPROS) to identify salt sensitivity of blood pressure (SSBP)

Description:

Participants are given dietary salt and their BP is measured every 10 minutes for 2 hours. IPROS is diagnosed with significant mean arterial pressure increase For SSBP, participants are put on high salt diet for a week and monitored and low salt week. The Mean arterial pressure difference between high salt and low salt is used to diagnose SSBP

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Participants will be included if they are males or females, aged 18-65 years.

Exclusion Criteria:

• Kidney disease, Cardiovascular disease

Related Conditions & MeSH terms

• High Blood Pressure
• Hypertension

Intervention

Other:
• salt
After =8 hr overnight fasting, participants will be required to ingest 780 mg of sodium (2 g salt) and BP measured every 10 minutes for 2 hours to determine IPROS. For SSBP, Participants are put on low salt (50 mmol Na/day) followed by seven days of high salt diet (250 mmol Na/day). Participants' mean arterial pressure (MAP) difference between low- and high-salt diet will be used to define salt sensitivity (MAP=8 mmHg) and salt resistance (MAP=5 mmHg).

Locations

Country	Name	City	State
Zambia	Livingstone University Teaching Hospital	Livingstone	Southern
Zambia	Kanyama General Hospital	Lusaka

Sponsors (1)

Lead Sponsor	Collaborator
Mulungushi University

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SSBP	Salt sensitivity status	2 weeks
Secondary	IPROS	Immediate pressor response	2 hours