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Effect of Spironolactone on Cardiovascular Morbidity and Mortality in Patients with Hypertension and Glucose Metabolism Disorders (ESCAM): a Pragmatic Randomized Clinical Trial

Effect of Spironolactone on Cardiovascular Morbidity and Mortality in Patients with Hypertension and Glucose Metabolism Disorders (ESCAM): a Pragmatic Randomized Clinical Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000028909
Enrollment
Unknown
Registered
2020-01-07
Start date
2020-02-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension and glucose metabolism disorders

Interventions

Spironolactone group:Add-on spironolactone to the original antihypertensive regimen
Non-spironolactone group:Free add-on but not mineralcorticoid receptors antagonists

Sponsors

Hypertension Institution of the People's Hospital of Xinjiang Uygur Autonomous Region; Hypertension Institute of Xinjiang Uygur Autonomous Region
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Male or female patients aged 45–75 years; 2. Office seated systolic blood pressure (SBP)>= 140mmHg or diastolic blood pressure (DBP)>= 90mmHg; or currently under anti-hypertension treatment; 3. Fasting blood-glucose >= 6.1mmol/L or postprandial glucose >= 7.8 mmol/L or diagnosed diabetes; 4. Serum potassium < 4.0 mmol/L.

Exclusion criteria

Exclusion criteria: 1. History of cardiovascular events within last 3 months (including myocardial infarction, heart failure, stroke, unstable angina, coronary revascularization and coronary bypass operation); 2. Renal dysfunction (Scr >= 178 umol/L or eGFR 5ULNALP > 5ULNBIL > 3ULN); 4. Serum uric acid > 520 umol/L); 5. Diagnosed secondary or resistant hypertension (including Cushing syndrome, adrenal tumor, pheochromocytoma, renal hypertension, polycystic ovary symdrome, and congenital adrenal disease) 6. Diagnosed malignant tumor within last 5 years; 7. Pregnant or breastfeeding women; 8. Contraindicated or allergic to spironolactone; 9. Severe mental disorders.

Design outcomes

Primary

MeasureTime frame
Incidence of cardiovascular events;Blood pressure;

Secondary

MeasureTime frame
Blood glucose;kidney function;

Countries

China

Contacts

Public ContactNanfang Li

Hypertension Institution of the People's Hospital of Xinjiang Uygur Autonomous Region; Hypertension Institute of Xinjiang Uygur Autonomous Region

lnanfang@vip.126.com+86 13999179937

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 17, 2026