Evidence map›Paper›PMID 39181551›Full record

Trial reportBMJ open2024

Randomised controlled decentralised feasibility trial of a fixed low-dose combination antihypertensive drug strategy to attenuate cognitive decline in high-risk adults.

Cheryl Carcel, Lauren Clancy, Katie Harris, Ruth Peters, Aisling Byrne, Kimberley Bassett, Ruth Freed, Camilla M Hoyos, Anthony Rodgers, Richard Lindley and 6 more

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

16 authors.

Cheryl Carcel *The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia ccarcel@georgeinstitute.org.au.ORCID 0000-0001-8942-953X
Lauren Clancy *The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia.
Katie HarrisThe George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia.
Ruth PetersThe George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia.
Aisling ByrneThe George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia.
Kimberley BassettBrain and Mind Centre, The University of Sydney, Camperdown, New South Wales, Australia.
Ruth FreedThe George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia.
Camilla M HoyosBrain and Mind Centre, The University of Sydney, Camperdown, New South Wales, Australia.ORCID 0000-0002-6543-4016
Anthony RodgersThe George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia.
Richard LindleyWestmead Applied Research Centre, University of Sydney, Sydney, New South Wales, Australia.ORCID 0000-0002-0104-5679
John ChalmersThe George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia.
Ying XuThe George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia.
Mark WoodwardThe George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia.
Menglu OuyangThe George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia.
Sharon L NaismithBrain and Mind Centre, The University of Sydney, Camperdown, New South Wales, Australia.
Craig AndersonThe George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe Action To promote brain HEalth iN Adults study aimed to determine the feasibility and applicability of recruitment using home blood pressure (BP) monitoring, routine blood biochemistry and videoconference measures of cognition, in adults at high risk of dementia.

designA decentralised double-blind, placebo-controlled, randomised feasibility trial with a four-stage screening process.

settingConducted with participants online in the state of New South Wales, Australia.

participantsParticipants were aged 50-70 years with moderately elevated BP (systolic >120 and <160 mm Hg or diastolic >80 and <95 mm Hg) and ≥1 additional enrichment risk factor of monotherapy treatment of hypertension, diabetes mellitus, elevated low-density lipoprotein cholesterol, obesity, current smoking or a first degree relative with dementia, which indicated an elevated risk for future cognitive decline.

interventionTriple Pill (active antihypertensive treatment of telmisartan 20 mg, amlodipine 2.5 mg and indapamide 1.25 mg) or placebo Triple Pill (blinded study capsules). PRIMARY AND SECONDARY OUTCOME MEASURES: Primary outcome was feasibility of the study expressed as the percentage of participants randomised from those who were screened. Secondary outcomes were the applicability of videoconference measures of cognition and the overall trial, tolerability of the Triple Pill, safety outcomes and medication adherence.

resultsThe proportion (95% CI) of patients randomised to those screened was 5% (2%-10%). The applicability of the trial expressed as percentage of those who completed all remote assessments over the number of randomised participants was 67% (95% CI 05 to 22%). There were no serious adverse events or withdrawals from treatment. All participants adhered to study medication, except for one person who had two capsules left at the end of the study period.

conclusionsThe feasibility of this decentralised trial on BP lowering in patients at high risk for dementia is low. However, the applicability of remote assessments of cognitive function is acceptable. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12621000121864.

Indexed as

Antihypertensive AgentsCognitive DysfunctionFeasibility StudiesHypertensionAgedAmlodipineBenzimidazolesBlood PressureBlood Pressure Monitoring, AmbulatoryDementiaDouble-Blind MethodDrug CombinationsFemaleHumansMaleMiddle AgedAmlodipineAntihypertensive AgentsBenzimidazolesDrug CombinationsTelmisartanBlood PressureClinical TrialDementia

Identifiers

PMID39181551
PMCPMC11344491

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.