Evidence map›Paper›PMID 31843024›Full record

ArticleTrials2019

Efficacy of chlorthalidone and hydrochlorothiazide in combination with amiloride in multiple doses on blood pressure in patients with primary hypertension: a protocol for a factorial randomized controlled trial.

Vítor Magnus Martins, Lucas Helal, Filipe Ferrari, Leonardo Grabinski Bottino, Sandra Costa Fuchs, Flávio Danni Fuchs

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03928145 (Efficacy of Chlorthalidone and Hydrochlorothiazide in Combination With Amiloride in Multiple Doses on Blood Pressure in Patients With Primary Hypertension), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.2field-weighted citation impact, top 41% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03928145 phase3unknown statusnot on this map

Efficacy of Chlorthalidone and Hydrochlorothiazide in Combination With Amiloride in Multiple Doses on Blood Pressure in Patients With Primary Hypertension: a Factorial Randomized Controlled Trial.

TypeinterventionalSponsorHospital de Clinicas de Porto AlegreRan2019 to 2021Enrolled84ConditionsHypertensionArmsChlorthalidone 25 mg, Hydrochlorothiazide 50 mg, Amiloride 20 mg, Amiloride 10 mg
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Medical Management of Coronary Artery Disease: An Update.The International journal of angiology : official publication of the International College of Angiology, Inc · 2025
    Review
  4. Dietary sodium intake does not alter renal potassium handling and blood pressure in healthy young males.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2022
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

Vítor Magnus MartinsGraduate Program in Cardiology and Cardiovascular Sciences, Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil. vmagnusmartins@gmail.com.
Lucas HelalGraduate Program in Cardiology and Cardiovascular Sciences, Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.
Filipe FerrariGraduate Program in Cardiology and Cardiovascular Sciences, Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.
Leonardo Grabinski BottinoGraduate Program in Cardiology and Cardiovascular Sciences, Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.
Sandra Costa FuchsGraduate Program in Cardiology and Cardiovascular Sciences, Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.
Flávio Danni FuchsGraduate Program in Cardiology and Cardiovascular Sciences, Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.
Universidade Federal do Rio Grande do Sul · BRHospital de Clínicas de Porto Alegre · BR

Funding

FIPE 2016-0553
6 · The paper itself

Abstract

backgroundThiazide diuretics have demonstrated favorable blood pressure lowering efficacy, but the equivalent doses of their more common agents, chlorthalidone and hydrochlorothiazide, are still unclear. Further, concerns exist regarding adverse metabolic effects, which may be attenuated with the concomitant administration of a potassium-sparing diuretic, such as amiloride. This trial aims to investigate the efficacy of chlorthalidone and hydrochlorothiazide, in combination with amiloride at different doses, for initial management of patients with primary hypertension. METHODS/

designThis is a factorial (2 × 2) randomized double-blinded clinical trial comparing the association of a thiazide diuretic (chlorthalidone 25 mg/day or hydrochlorothiazide 50 mg/day) with a potassium-sparing diuretic (amiloride 10 mg/day or amiloride 20 mg/day) in patients with primary hypertension. The primary outcome will be the mean change from baseline in 24-h systolic and diastolic blood pressure measured by ambulatory blood pressure monitoring. The secondary outcomes will be the mean change from baseline in daytime and nighttime systolic and diastolic blood pressure measured by ambulatory blood pressure monitoring, mean change from baseline in systolic and diastolic blood pressure measured by office blood pressure, incidence of adverse events, variation of laboratory parameters, and proportion of patients who achieved blood pressure control. The follow-up will last 12 weeks. For a P alpha of 0.05, power of 80%, standard deviation of 9 mmHg, and absolute difference of 6 mmHg on systolic blood pressure on 24-h ambulatory blood pressure monitoring, it will be necessary to study a total of 76 patients. The sample size will be increased by 10% to compensate for losses, resulting in 84 patients being randomized. DISCUSSION: Diuretics are pivotal drugs for the treatment of hypertension. Chlorthalidone and hydrochlorothiazide, in combination with amiloride in multiple doses, will be tested in terms of blood pressure lowering efficacy and safety. Since the intensity of blood pressure reduction is the major determinant of reduction in cardiovascular risk in hypertensive patients, this study will help to determine which combination of diuretics represents the most appropriate treatment for this population.

trial registrationClinicalTrials.gov, NCT03928145. Registered on 25 April 2019. Last update on 29 April 2019.

Indexed as

AmilorideAntihypertensive AgentsBlood PressureBrazilChlorthalidoneDouble-Blind MethodDrug CombinationsHumansHydrochlorothiazideHypertensionRandomized Controlled Trials as TopicSodium Chloride Symporter InhibitorsTime FactorsTreatment OutcomeAmilorideamiloride, hydrochlorothiazide drug combinationAntihypertensive AgentsChlorthalidoneDrug CombinationsHydrochlorothiazideSodium Chloride Symporter InhibitorsAmilorideBlood pressureDiureticsHypertensionThiazidesTreatment

Identifiers

PMID31843024
PMCPMC6916111
OpenAlexW2994730845

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.