Spironolactone Versus Indapamide in Obese and Hypertensive Patients

NCT03626506 | Unknown DMC

• 1 other identifier: BMUJI007
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Most recent guidelines continue to recommend thiazide diuretics as first-line agents for patients with hypertension in spite of the potential metabolic side effects, while mineralocorticoid receptor antagonists (MRAs), such as spironolactone or eplerenone, are mainly recommended to be used in patients with resistant hypertension or heart failure.However,animal studies demonstrated that MRAs induce beneficial changes in left ventricular remodeling and prevent or partially reverse cardiac fibrosis and pathological hypertrophy that contribute to the development of diastolic heart failure. MRAs have also been shown to decrease inflammation and myocardial fibrosis in patients with obesity and the metabolic syndrome. In the proposed study, the investigators planned to randomize 400 patients with essential hypertension and increased waist circumference to receive spironolactone or indapamide in combination with amlodipine for 12 months. The effects of the two diuretics on target organ damage detected by changes in left atrial volume index(LAVI) by echocardiography reflecting left ventricular diastolic dysfunction or changes in carotid-femoral pulse wave velocity(PWV) reflecting arterial stiffness will be compared. The potential role of MRAs as initial therapy for patients with essential hypertension and visceral obesity will be evaluated.

Conditions

Hypertension

Keywords

spironolactone; Indapamide; Obesity; Hypertension; Target organ damage

Outcome Measures

Primary Outcomes (1)

• left atrial volume index (LAVI)

  change in left atrial volume index (LAVI) from baseline to the end of study period of 12 months

  12 months

Secondary Outcomes (1)

• carotid-femoral pulse wave velocity (PWV)

  12 months

Study Arms (2)

spironolactone

EXPERIMENTAL

Subjects will take spironolactone 20\~40mg once daily on top of amlodipine 5\~10mg once daily.

Drug: Spironolactone; Drug: Amlodipine

indapamide

ACTIVE COMPARATOR

Subjects will take indapamide 1.5\~3.0mg once daily on top of amlodipine 5\~10mg once daily.

Drug: Indapamide; Drug: Amlodipine

Interventions

Spironolactone DRUG

After a 2-week run-in period on amlodipine, patients who still have SBP ≥ 140mmHg will take spironolactone 20mg once daily on top of amlodipine for 12 months. During the first two months after randomization, spironolactone can be titrated to 40mg if office SBP remains ≥ 140mmHg.

spironolactone

Indapamide DRUG

After a 2-week run-in period on amlodipine, patients who still have SBP ≥ 140mmHg will take extended-release indapamide 1.5mg once daily on top of amlodipine for 12 months. During the first two months after randomization, indapamide can be titrated to 3mg if office SBP remains ≥ 140mmHg.

indapamide

Amlodipine DRUG

After a 2-week run-in period on amlodipine 5mg once daily, patients who still have SBP ≥ 140mmHg will be randomized to add spironolactone 20mg once daily or extended-release indapamide 1.5mg once daily to amlodipine for 12 months. During the first two months after randomization, amlodipine can be titrated to 10mg if office SBP remains ≥ 140mmHg.

indapamide; spironolactone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with essential hypertension aged between 18-80years
• Office systolic blood pressure (SBP)≥140mmHg and \<180mmHg without treatment or on one antihypertensive drug or SBP\<140mmHg on two antihypertensive drugs
• Waist circumference ≥90cm for males, ≥ 80cm for females

You may not qualify if:

• Secondary hypertension.
• Symptomatic congestive heart failure or history of heart failure.
• History of ischemic stroke, unstable angina or myocardial infarction;
• Atrial fibrillation
• Serum creatinine ≥ 2.0mg/dl or eGFR≤ 30 ml/min/1.73 m2
• Serum K+ ≥ 5.0 mmol/L or ≤3.5 mmol/L

Sponsors & Collaborators

• Peking University Third Hospital: lead
• University of Michigan: collaborator
• Peking University: collaborator

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Hypertension; Obesity

Interventions

Spironolactone; Indapamide; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sulfonamides; Amides; Sulfones; Sulfur Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Wang Guisong, MD

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guisong Wang, MD

CONTACT

86-13701070359; guisongwang2007@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, controlled, open-label trial

Study Record Dates

• First Submitted: August 3, 2018
• First Posted: August 13, 2018
• Study Start: February 13, 2019
• Primary Completion: August 1, 2020
• Study Completion: December 1, 2020
• Last Updated: December 3, 2019

Record last verified: 2019-04

Locations

CN (1)