Diuretics, Hypertension, and Arrhythmias Clinical Trial

NCT00000525 | Completed Phase 3

• 2 other identifiers: 44R01HL036821
• Study Type: interventional
• Target: 233
• Locations: 0 countries
• Sites: N/A

Brief Summary

To determine whether hypertensive patients with ECG abnormalities and receiving hydrochlorothiazide diuretics were at increased risk of sudden death.

Conditions

Cardiovascular Diseases; Death, Sudden, Cardiac; Heart Arrest; Heart Diseases; Hypertension

Interventions

hydrochlorothiazide DRUG

diet, potassium supplementation BEHAVIORAL

diet, magnesium supplementation BEHAVIORAL

triamterene DRUG

chlorthalidone DRUG

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Men, ages 35 to 70, with ECG abnormalities, diastolic blood pressure less than 95 mm Hg at entry. Subjects had been treated for at least six months by their own physicians with hydrochlorothiazide (HCT), HCT and potassium supplementation, triamteren

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Related Publications (6)

• Siegel D, Cheitlin MD, Black DM, Seeley D, Hearst N, Hulley SB. Risk of ventricular arrhythmias in hypertensive men with left ventricular hypertrophy. Am J Cardiol. 1990 Mar 15;65(11):742-7. doi: 10.1016/0002-9149(90)91381-f.

  PMID: 2138408 BACKGROUND

• Chang SW, Fine R, Siegel D, Chesney M, Black D, Hulley SB. The impact of diuretic therapy on reported sexual function. Arch Intern Med. 1991 Dec;151(12):2402-8.

  PMID: 1746997 BACKGROUND

• Siegel D, Black DM, Seeley DG, Hulley SB. Circadian variation in ventricular arrhythmias in hypertensive men. Am J Cardiol. 1992 Feb 1;69(4):344-7. doi: 10.1016/0002-9149(92)90231-m.

  PMID: 1734646 BACKGROUND

• Siegel D, Hulley SB, Black DM, Cheitlin MD, Sebastian A, Seeley DG, Hearst N, Fine R. Diuretics, serum and intracellular electrolyte levels, and ventricular arrhythmias in hypertensive men. JAMA. 1992 Feb 26;267(8):1083-9.

  PMID: 1735925 BACKGROUND

• Siegel D, Cheitlin MD, Seeley DG, Black DM, Hulley SB. Silent myocardial ischemia in men with systemic hypertension and without clinical evidence of coronary artery disease. Am J Cardiol. 1992 Jul 1;70(1):86-90. doi: 10.1016/0002-9149(92)91395-k.

  PMID: 1615875 BACKGROUND

• Siegel D, Saliba P, Haffner S. Glucose and insulin levels during diuretic therapy in hypertensive men. Hypertension. 1994 Jun;23(6 Pt 1):688-94. doi: 10.1161/01.hyp.23.6.688.

  PMID: 8206564 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Death, Sudden, Cardiac; Heart Arrest; Heart Diseases; Hypertension

Interventions

Hydrochlorothiazide; Diet; Triamterene; Chlorthalidone

Condition Hierarchy (Ancestors)

Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases

Intervention Hierarchy (Ancestors)

Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Pteridines; Benzenesulfonamides; Amides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Benzophenones; Phthalimides; Imides; Ketones; Isoindoles

Study Officials

• Stephen Hulley

  University of California

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 27, 1999
• First Posted: October 28, 1999
• Study Start: July 1, 1986
• Primary Completion: September 1, 1989
• Last Updated: September 19, 2013

Record last verified: 2013-09