Effects of mineralocorticoid receptor antagonist on intradialytic hypertension: a multicenter, double-blind, randomized crossover study

Phase 2

Completed

• Conditions: Intradialytic hypertension; Spironolactone; Mineralocorticoid receptor antagonist

• Registration Number: TCTR20200604013
• Lead Sponsor: ampang hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-04
• Study Completion: 2023-01-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

1. ESRD patients (defined by Kidney Disease Initiative Global Outcome (KDIGO)
Guideline 2012) requiring chronic hemodialysis
2. Hemodialysis vintage more than 12 weeks
3. Hemodialysis with at least 2 sessions per week
4. History of intradialytic hypertension (defined by an increase in systolic blood pressure >15 mmHg or mean arterial pressure >10 mmHg during hemodialysis) at least 30% of their dialysis sessions during the past 12 weeks

Exclusion Criteria

1. Serum potassium >5.5 mEq/L or <2.5 mEq/L
2. Active cardiac, pulmonary or hepatobiliary tract disease
3. Active infection or sepsis
4. Active malignancy
5. Cirrhosis
6. Prior treatment with spironolactone in past 4 weeks
7. Contraindication to spironolactone
8. Interdialytic weight gain more than 6%

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of intradialytic hypertension 24-week study period Proportion of intradialytic hypertension (%)

Secondary Outcome Measures

Name	Time	Method
Intradialytic blood pressure 24-week study period Blood pressure (mmHg),Serum potassium End of study mEq/L,Pre-dialysis blood pressure 24-week study period Blood pressure (mmHg),Post-dialysis blood pressure 24-week study period Blood pressure (mmHg),Prespecified subgroup analyses of the primary outcome 24-week study period diabetes, receiving ACEI/ARB, receiving more than three anti-hypertensive medications and the presence of residual kidney function (RKF),Peak intradialytic blood pressure 24-week study period Blood pressure (mmHg)