Last reviewed · How we verify
NCT01896661
The Effect of Antihypertensive Agents Over Sleep Apnea: a Randomized Controlled Trial
Phase 3 trial testing Diuretics in Hypertension in 53 participants. Completed in 1 February 2016.
1 December 2015
Quick facts
| Lead sponsor | Hospital de Clinicas de Porto Alegre |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 53 |
| Start date | 1 December 2014 |
| Primary completion | 1 December 2015 |
| Estimated completion | 1 February 2016 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- Diuretics — full drug profile →
- Calcium Channel Blockers — full drug profile →
Conditions studied
- Hypertension — all drugs for Hypertension →
- Obstructive Sleep Apnea — all drugs for Obstructive Sleep Apnea →
Sponsor
Hospital de Clinicas de Porto Alegre
Who can join
40 and older, any sex, with Hypertension or Obstructive Sleep Apnea. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Apnea-Hypopnea Index
Time frame: 8 weeks
Number of apneas/hour -
Blood Pressure
Time frame: 8 weeks
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
The effect of antihypertensive agents on sleep apnea: protocol for a randomized controlled trial.
Cichelero FT, Martinez D, Fuchs SC, Gus M, et al · · 2014 · cited 33× · PMID 24382030 · DOI 10.1186/1745-6215-15-1 -
Effect of antihypertensive agents on sleep apnea and ambulatory blood pressure in patients with hypertension: A randomized controlled trial.
Cichelero FT, Fuchs SC, Jorge JA, Martinez D, et al · · 2024 · cited 1× · PMID 38781664 · DOI 10.1016/j.sleep.2024.05.035 -
Effects of chlorthalidone plus amiloride compared with amlodipine on short-term blood pressure variability in individuals with hypertension and obstructive sleep apnea: a randomized controlled trial.
Lucca MB, Jorge JA, Cichelero FT, Martinez D, et al · · 2023 · PMID 37466401 · DOI 10.1097/mbp.0000000000000663
Verify or expand the search:
- PubMed search for NCT01896661
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Diuretics
Trials testing the same drug.
- NCT05527054 — Risk Factors and Machine Learning Model for Diuretics Related Acute Kidney Injury · unknown
- NCT05430243 — Empagliflozin as a Novel Therapy in Refractory Ascites · Phase 2, PHASE3 · completed
- NCT03645642 — To Study the Safety and Efficacy of Midodrine With Albumin Versus Albumin Alone in Hepatic Hydrothorax · NA · completed
- NCT03395951 — Mean Systemic Filling Pressure Continuous Diuretics Critical Care Patients · completed
Other recruiting trials for Hypertension
Currently open trials in the same condition.
- NCT07413159 — The "Check, Monitor, Control Hypertension" Study is a 24-month Randomized Trial in Houston Targeting African Americans A · NA · recruiting
- NCT07361276 — Observational Study That Will Evaluate Treatment Patterns in the Management of Hypertension in the Public Primary Care S · recruiting
- NCT07238556 — A Novel Digital Tool Physicians Can Use to Prescribe Exercise to Patients With Cardiovascular Disease Risk Factors · NA · recruiting
- NCT07238400 — Cardiac Effects of Mineralocorticoid Receptor Antagonism After Preeclampsia · Phase 2 · recruiting
- NCT07135505 — Early Time-Restricted Eating in Older Adults With Hypertension · NA · recruiting
Other Hospital de Clinicas de Porto Alegre trials
Trials by the same sponsor.
- NCT07469722 — POcus INTERvention for Tailoring Diuretic Strategy in Acute Decompensated Heart Failure · Phase 2, PHASE3 · not yet recruiting
- NCT07264179 — Tracheal Cuff Pressure and Postoperative Complications: A Prospective Observational Study. · not yet recruiting
- NCT07052058 — Triple-Blind Randomized Clinical Trial of Tocilizumab vs Placebo: Potential Use of an IL-6 Antagonist as an Adjuvant to · Phase 2 · not yet recruiting
- NCT06953128 — General Versus Regional Anesthesia in Peripheral Arterial Surgery · NA · not yet recruiting
- NCT06934707 — Meal Frequency and Glycemic Control in Individuals With Type 1 Diabetes · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01896661 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospital de Clinicas de Porto Alegre
- Last refreshed: 13 July 2016
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01896661.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing