Evidence map›Paper›PMID 28292320›Full record

Trial reportTrials2017

Addition of Propranolol in Resistant Arterial hypertension Treatment (APROPRIATE study): study protocol for a randomized double-blind placebo-controlled trial.

G R Constantine, P Ranasinghe, P Weeratunga, C Weeraratne, P Galappatthy, S Rajapakse, U Senarath, P Katulanda

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.9field-weighted citation impact, top 24% 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.

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

3 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
  2. Resistant Hypertension: Mechanisms and Treatment.Current hypertension reports · 2017
    Review
  3. Propranolol: A 50-Year Historical Perspective.Annals of Indian Academy of Neurology
    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

8 authors at 1 institution in 1 country.

G R ConstantineDepartment of Clinical Medicine, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka. grogerconstantine@gmail.com.
P RanasingheDepartment of Pharmacology, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.
P WeeratungaDepartment of Clinical Medicine, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.
C WeeraratneDepartment of Pharmacology, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.
P GalappatthyDepartment of Pharmacology, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.
S RajapakseDepartment of Clinical Medicine, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.
U SenarathDepartment of Community Medicine, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.
P KatulandaDepartment of Clinical Medicine, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.
University of Colombo · LK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundResistant hypertension is defined as an uncontrolled blood pressure despite treatment at best-tolerated doses with at least three antihypertensive agents including a diuretic. It is an emerging public health problem. At present clinical trial data on management of resistant hypertension is limited. Management is largely based on observational studies and expert opinions. Propranolol is a nonselective beta blocker. Several studies have confirmed that propranolol has a significant hypotensive action, both when used alone and as an adjuvant therapy. At present there are no prospective, randomized, clinical studies evaluating the effectiveness of propranolol in patients with resistant hypertension. Therefore, we have designed a prospective randomized trial to evaluate the safety and efficacy of propranolol in patients with resistant hypertension. METHODS/

designThe study will be conducted as a randomized, double-blind, placebo-controlled clinical trial for a period of 3 months. The study has been approved by the Ethics Review Committee of the Faculty of Medicine, University of Colombo. A total of 200 adults with resistant hypertension will be recruited for the study. They will be randomly assigned to the test and placebo groups on a 1:1 ratio. The test group will receive propranolol 40 mg three times a day and the control group will receive an identical placebo capsule. The study drugs will be double blinded to both investigators and subjects. The visits and the evaluations will be done as follows: screening (visit 0), 1 month (visit 1), 2 months (visit 2) and 3 months (visit 3). The primary outcomes of the study is to find a statistically significant difference between the fall in mean systolic and mean diastolic blood pressure measured by ABPM (ambulatory blood pressure monitoring) from baseline between the two groups. Data will be analyzed using SPSS v16. DISCUSSION: To our knowledge this is one of the first randomized controlled trials evaluating the effects of propranolol in resistant hypertension. This study will provide the necessary groundwork for future large-scale, multicentered clinical trials. The result, positive or negative, should provide a step change in the evidence guiding current and future policies regarding treatment of resistant hypertension.

trial registrationSri Lanka Clinical Trials Registry, identifier: SLCTR/2016/002 . Registered on 27 January 2016; Study protocol version 2.1.

Indexed as

AdolescentAdrenergic beta-AntagonistsAdultAgedAntihypertensive AgentsArterial PressureBlood Pressure Monitoring, AmbulatoryClinical ProtocolsDouble-Blind MethodDrug ResistanceDrug Therapy, CombinationFemaleHumansHypertensionMaleMiddle AgedAdrenergic beta-AntagonistsAntihypertensive AgentsPropranololVasodilator AgentsPropranololRandomized controlled trialResistant hypertensionSri Lanka

Identifiers

PMID28292320
PMCPMC5351190
OpenAlexW2596119642

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.