Matão Controlling Hypertension (MatCH Study): Rationale and Design

NCT03147092 | Unknown Early Phase 1 DMC

• 1 other identifier: CMinelli
• Study Type: interventional
• Target: 15,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background Hypertension is the main risk factor for most cardiovascular diseases. Blood pressure (BP) control has been shown to reduce the incidence of stroke, myocardial infarction, renal diseases and heart failure. Although BP lowering is effective, few population programs can achieve BP control. A coordinated and organized system from the Brazilian Ministry of Healthy involving Family Health Strategy (FHS), a program for the prevention of chronic disease, and the Popular Pharmacy Program (PPP), which subsidizes medications for the population, could allow an earlier identification and better BP control. Matão Controlling Hypertension (MatCH) is a community-based population project that aims to apply an organized, integrated and coordinated program in the city of Matão, Brazil, involving FSH and PPP in order to actively search, treat and follow-up hypertensive subjects. Method This is a population community-based, prospective, interventional, follow-up study where all subjects aged ≥ 40 years assisted by the FHS program in Matão will have BP assessed monthly by trained Community Health Agents (CHA) during a domiciliary visit. Identified hypertensive subjects will be referred to FHS physicians for nonpharmacological and pharmacological treatment. Most of the hypertensive drugs used will be available thought the PPP. Prevalence of hypertension, awareness, demographics and risk factors will be correlated with BP control. The population study is expected to involve approximately 15,000 subjects. The study period will be four years. Discussion Considering that hypertension is asymptomatic in most cases, to reduce the population burden of BP-related deaths and diseases it is essential to detect and treat early all hypertensive patients. If BP control be achieved on a large scale, this program can be applied to other populations from developing countries.

Conditions

Hypertension; Blood Pressure

Outcome Measures

Primary Outcomes (1)

• Number of hypertensive subjects with BP controlled during follow-up

  Controlled BP will be defined as systolic blood pressure ≤ 139 mmHg and diastolic blood pressure ≤ 89 mmHg.

  Through study completion, an average of 2 years

Secondary Outcomes (3)

• Correlation of BP control with demographics

  Through study completion, an average of 3 years

• Correlation of BP control with risk factors

  Through study completion, an average of 3 years

• Correlation of BP end organ disease

  Through study completion, an average of 3 years.

Study Arms (1)

Hypertension group

EXPERIMENTAL

Hypertensive patients will be counseled to initiate life style changes as weight loss, salt reduction, exercise, reduced alcohol consumption, smoking cessation and fresh fruits and vegetables in their diets. Drug treatment will be started for subjects that are not responding to nonpharmacological treatment. The anti-hypertensive medications will be Captopril 25Mg, Hydrochlorothiazide 25Mg Oral Tablet, atenolol and Losartan potassium 50 mg. All of these anti-hypertensive drugs are available in the PPP. If BP control is not yet obtained, other antihypertensive drugs will be requested: clonidine, spironolactone, hydralazine and amlodipine.

Drug: Captopril 25Mg, Hydrochlorothiazide 25Mg Oral Tablet,; Drug: Atenolol; Drug: Losartan potassium 50mg; Drug: Clonidine

Interventions

Captopril 25Mg, Hydrochlorothiazide 25Mg Oral Tablet, DRUG

Treatment of hypertensive subjects

Hypertension group

Atenolol DRUG

Treatment of hypertensive subjects

Hypertension group

Losartan potassium 50mg DRUG

Treatment of hypertensive subjects

Hypertension group

Clonidine DRUG

Treatment of hypertensive subjects

Hypertension group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All consented subjects aged ≥ 40 years belonging to Family Strategy Health program and residing in Matão.

You may not qualify if:

• Patients younger than 40 years.
• Subjects not belonging to Family Strategy Health program in Matão.

Sponsors & Collaborators

• Centro Neurológico de Pesquisa e Reabiitação, Brazil: lead

Related Publications (7)

• Ribeiro AL, Duncan BB, Brant LC, Lotufo PA, Mill JG, Barreto SM. Cardiovascular Health in Brazil: Trends and Perspectives. Circulation. 2016 Jan 26;133(4):422-33. doi: 10.1161/CIRCULATIONAHA.114.008727.

  PMID: 26811272 RESULT

• Macinko J, Harris MJ. Brazil's family health strategy--delivering community-based primary care in a universal health system. N Engl J Med. 2015 Jun 4;372(23):2177-81. doi: 10.1056/NEJMp1501140. No abstract available.

  PMID: 26039598 RESULT

• Emmerick IC, do Nascimento JM Jr, Pereira MA, Luiza VL, Ross-Degnan D; ISAUM-Br Collaborative Group. Farmacia Popular Program: changes in geographic accessibility of medicines during ten years of a medicine subsidy policy in Brazil. J Pharm Policy Pract. 2015 Mar 9;8(1):10. doi: 10.1186/s40545-015-0030-x. eCollection 2015.

  PMID: 25926990 RESULT

• Malachias MVB, Gomes MAM, Nobre F, Alessi A, Feitosa AD, Coelho EB. 7th Brazilian Guideline of Arterial Hypertension: Chapter 2 - Diagnosis and Classification. Arq Bras Cardiol. 2016 Sep;107(3 Suppl 3):7-13. doi: 10.5935/abc.20160152. No abstract available.

  PMID: 27819381 RESULT

• Malachias MVB, Paulo Cesar Veiga Jardim PCV Junior, Almeida FA, Lima E Junior, Feitosa GS. 7th Brazilian Guideline of Arterial Hypertension: Chapter 7 - Pharmacological Treatment. Arq Bras Cardiol. 2016 Sep;107(3 Suppl 3):35-43. doi: 10.5935/abc.20160157. No abstract available.

  PMID: 27819386 RESULT

• Arima H, Barzi F, Chalmers J. Mortality patterns in hypertension. J Hypertens. 2011 Dec;29 Suppl 1:S3-7. doi: 10.1097/01.hjh.0000410246.59221.b1.

  PMID: 22157565 RESULT

• Minelli C, Borin LA, Trovo Mde C, Dos Reis GC. Hypertension Prevalence, Awareness and Blood Pressure Control in Matao, Brazil: A Pilot Study in Partnership With the Brazilian Family Health Strategy Program. J Clin Med Res. 2016 Jul;8(7):524-30. doi: 10.14740/jocmr2582w. Epub 2016 May 29.

  PMID: 27298661 RESULT

Related Links

• Family Health Strategy Program, extension

MeSH Terms

Conditions

Hypertension

Interventions

Captopril; Hydrochlorothiazide; Tablets; Atenolol; Losartan; Clonidine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Proline; Imino Acids; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Tetrazoles; Imidazolines

Study Officials

• Cesar Minelli, MD, PhD

  Hospital Carlos Fernando Malzoni

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cesar Minelli, MD, PhD

CONTACT

+55-16-999923396; cdminelli@yahoo.com.br

Lucileni A Borin

CONTACT

+55-16-33832527; lucileni.borin@hopitalmatao.com.br

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single group of hypertensive individuals will be submitted to same treatment.

Study Record Dates

• First Submitted: April 30, 2017
• First Posted: May 10, 2017
• Study Start: February 1, 2018
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2021
• Last Updated: November 21, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share