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Matão Controlling Hypertension (MatCH Study): Rationale and Design (MatCH)

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ClinicalTrials.gov Identifier: NCT03147092
Recruitment Status : Not yet recruiting
First Posted : May 10, 2017
Last Update Posted : November 21, 2017
Sponsor:
Information provided by (Responsible Party):
Centro Neurológico de Pesquisa e Reabiitação, Brazil

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.


Condition or disease Intervention/treatment Phase
Hypertension Blood Pressure Drug: Captopril 25Mg, Hydrochlorothiazide 25Mg Oral Tablet, Drug: Atenolol Drug: Losartan potassium 50mg Drug: Clonidine Early Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15000 participants
Intervention Model: Single Group Assignment
Intervention Model Description: A single group of hypertensive individuals will be submitted to same treatment.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Matão Controlling Hypertension (MatCH Study): Rationale and Design. Project to Reduce Incidence of Arterial Hypertension in City of Matão, Brazil.
Estimated Study Start Date : February 1, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hypertension group
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,
Treatment of hypertensive subjects

Drug: Atenolol
Treatment of hypertensive subjects

Drug: Losartan potassium 50mg
Treatment of hypertensive subjects

Drug: Clonidine
Treatment of hypertensive subjects




Primary Outcome Measures :
  1. Number of hypertensive subjects with BP controlled during follow-up [ Time Frame: Through study completion, an average of 2 years ]
    Controlled BP will be defined as systolic blood pressure ≤ 139 mmHg and diastolic blood pressure ≤ 89 mmHg.


Secondary Outcome Measures :
  1. Correlation of BP control with demographics [ Time Frame: Through study completion, an average of 3 years ]
    Age, gender, years of education.

  2. Correlation of BP control with risk factors [ Time Frame: Through study completion, an average of 3 years ]
    Previous history of hypertension, diabetes mellitus, dyslipidemia, alcohol abuse, smoking, and physical activity

  3. Correlation of BP end organ disease [ Time Frame: Through study completion, an average of 3 years. ]
    previous history of stroke, coronary artery disease, chronic kidney disease, peripheral artery disease.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03147092


Contacts
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Contact: Cesar Minelli, MD, PhD +55-16-999923396 cdminelli@yahoo.com.br
Contact: Lucileni A Borin +55-16-33832527 lucileni.borin@hopitalmatao.com.br

Sponsors and Collaborators
Centro Neurológico de Pesquisa e Reabiitação, Brazil
Investigators
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Principal Investigator: Cesar Minelli, MD, PhD Hospital Carlos Fernando Malzoni

Additional Information:
Publications of Results:

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Responsible Party: Centro Neurológico de Pesquisa e Reabiitação, Brazil
ClinicalTrials.gov Identifier: NCT03147092     History of Changes
Other Study ID Numbers: CMinelli
First Posted: May 10, 2017    Key Record Dates
Last Update Posted: November 21, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atenolol
Hypertension
Vascular Diseases
Cardiovascular Diseases
Losartan
Hydrochlorothiazide
Clonidine
Captopril
Captopril, hydrochlorothiazide drug combination
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Adrenergic beta-1 Receptor Antagonists