Effect of Antihypertensive Agents Over Sleep Apnea

NCT01896661 | Completed Phase 3

• 2 other identifiers: 07572112.7.0000.532712-0417
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

Obstructive sleep apnea and hypertension are well-known cardiovascular risk factors. Their control could reduce the burden of heart disease across populations. There are several drugs to control hypertension, but the only consistently beneficial treatment to reduce apneas is continuous positive airway pressure. The demonstration that one drug could improve sleep apnea and hypertension would support a novel approach in the treatment of both diseases. The role of fluid retention in sleep apnea is known for several decades. The role of diuretics is well established in hypertension but was never appropriately tested in sleep apnea. Besides to test the efficacy of these drugs, this study will help to understand the mechanisms that link hypertension and sleep apnea and its treatment.

Conditions

Hypertension; Obstructive Sleep Apnea

Keywords

Sleep apnea; Hypertension; Treatment; Diuretics; Chlorthalidone; Amlodipine

Outcome Measures

Primary Outcomes (2)

• Apnea-Hypopnea Index

  Number of apneas/hour

  8 weeks

• Blood Pressure

  8 weeks

Secondary Outcomes (3)

• Adverse events

  8 weeks

• Somnolence scale (Epworth) and ventilatory parameters

  8 weeks

• C reactive protein

  8 weeks

Study Arms (2)

Diuretics

EXPERIMENTAL

Chlorthalidone plus amiloride 25 and 5 mg daily, taking in the morning

Drug: Diuretics

Calcium Channel Blockers

ACTIVE COMPARATOR

Amlodipine 10 mg daily, taking in the morning

Drug: Calcium Channel Blockers

Interventions

Diuretics DRUG

Chlorthalidone plus amiloride 25 and 5 mg daily, taking in the morning

Also known as: Chlorthalidone/Amiloride

Diuretics

Calcium Channel Blockers DRUG

Amlodipine 10 mg daily, taking in the morning

Also known as: Amlodipine

Calcium Channel Blockers

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 40 years of age
• Stage I hypertension (140-159/90-99 mmHg) and moderate obstructive sleep apnea (10-40 apneas/hour of sleep)

You may not qualify if:

• Low life expectancy
• Other indications for the use of diuretics or calcium channel blocker -Intolerance or contraindications to the study drugs
• Pregnancy
• Established cardiovascular disease (myocardial infarction
• Stroke
• Heart failure)
• Use of more than one drug for hypertension
• Secondary hypertension
• Participation in other clinical trial in previous 6 months

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Related Publications (2)

• Cichelero FT, Fuchs SC, Jorge JA, Martinez D, Oliveira GPF, Lucca MB, Oliveira ACT, Fuchs FD. Effect of antihypertensive agents on sleep apnea and ambulatory blood pressure in patients with hypertension: A randomized controlled trial. Sleep Med. 2024 Jul;119:417-423. doi: 10.1016/j.sleep.2024.05.035. Epub 2024 May 16.

  PMID: 38781664 DERIVED

• Cichelero FT, Martinez D, Fuchs SC, Gus M, Moreira LB, Fuchs FD. The effect of antihypertensive agents on sleep apnea: protocol for a randomized controlled trial. Trials. 2014 Jan 2;15:1. doi: 10.1186/1745-6215-15-1.

  PMID: 24382030 DERIVED

MeSH Terms

Conditions

Hypertension; Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Interventions

Diuretics; Chlorthalidone; Amiloride; Calcium Channel Blockers; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Natriuretic Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Benzophenones; Phthalimides; Imides; Ketones; Sulfones; Sulfur Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pyrazines; Heterocyclic Compounds, 1-Ring; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Calcium-Regulating Hormones and Agents; Cardiovascular Agents; Therapeutic Uses; Dihydropyridines; Pyridines

Study Officials

• Flavio D Fuchs, MD, PhD

  Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul

  STUDY CHAIR

• Fabio T Cichelero, MD

  Federal University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2013
• First Posted: July 11, 2013
• Study Start: December 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: February 1, 2016
• Last Updated: July 14, 2016

Record last verified: 2016-07

Locations

BR (1)