Dietary Counselling for Hypertension

2
Effectiveness
3
Safety
Jessica Wagner, Ottawa, Canada
Hypertension
Dietary Counselling - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Hypertension

Study Summary

This study is evaluating whether increasing potassium intake can reduce blood pressure in people with high blood pressure.

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Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether Dietary Counselling will improve 1 primary outcome and 3 secondary outcomes in patients with Hypertension. Measurement will happen over the course of 4 weeks.

4 weeks
Successful increase in potassium intake
Week 52
Gastrointestinal Events
Hyperkalemia Events
52 weeks
Persistence of increase in potassium intake at 52 weeks

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Potassium Citrate Supplement
Dietary Counselling

This trial requires 120 total participants across 2 different treatment groups

This trial involves 2 different treatments. Dietary Counselling is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Dietary Counselling
Behavioral
All enrolled patients will undergo a 1:1 counselling with a registered dietitian (with possible inclusion of family members, as appropriate). The dietitian will undertake an assessment of the comorbidities (e.g. diabetes), dietary intake, dietary habits (e.g. eating out, food preparation, socio-cultural aspects) and provide an individually tailored strategy to increase potassium in the diet. Secondly, on a weekly basis, the dietitian will contact the patient by telephone, or electronically (as preferred by the patient) to reinforce the advice and provide support/advice as necessary.
Potassium Citrate SupplementPatients who are not able to successfully increase their potassium intake at 4 weeks with dietary counselling will receive potassium citrate supplements. They will receive oral potassium supplementation in the form of 50 to 100 mmol of potassium citrate (as 25 to 50 ml of the liquid solution).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dietary Counselling
2016
Completed Phase 3
~330

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 weeks to 52 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 4 weeks to 52 weeks for reporting.

Closest Location

Jessica Wagner - Ottawa, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Male or female, aged 18 and greater (women of child bearing potential must use highly effective contraception (e.g. combined oral contraceptives, patch, vaginal ring, injectables, and implants; intrauterine device (IUD) or intrauterine system (IUS); vasectomy of male partner and tubal ligation)
24-Hour Urine K < 60 mmol/day
Provides signed and dated informed consent form
Diagnosis of hypertension (either on treatment; or not on treatment with an ambulatory blood pressure monitor (ABPM)- daytime systolic blood pressure (SBP) > 140 or diastolic blood pressure (DBP) > 90)

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get hypertension a year in the United States?

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About 45% of US adults have hypertension, and it is on the rise. Although hypertension is not the leading cause of death, it is a major risk factor for many other conditions, including stroke, heart attack, kidney disease, and some types of cancer. Hypertension management and reducing its complications and health care costs have been recognized as priorities by the US government and guidelines by professional organizations.

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What causes hypertension?

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Hypertension was more common in men than women. The prevalence of obesity was positively associated with hypertension. Most hypertension was diagnosed on screening by physicians or screening from the health clinic. Screening for hypertension should be done as part of the routine medical evaluation for young people, and hypertension screening should be recommended to prevent hypertensive cardiovascular diseases.

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Can hypertension be cured?

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Asymmetrical hypertensive pulse morphology may be associated with increased cerebrovascular risk. Given the lack of conclusive evidence, treatment of left ventricular dysfunction in hypertension remains a subject of clinical discussion.

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What are common treatments for hypertension?

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More than half of those with hypertension may be treated by a combination of three or fewer different therapies to achieve a goal BP measurement or to improve their quality of life.

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What are the signs of hypertension?

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The standard method for establishing the diagnosis of hypertension is through non-invasive blood pressure measurements. As hypertension progresses, many patients will present with the classical symptoms of hypertension and an increase in blood pressure, including headache, palpitations, dizziness, abnormal sensations, chest pain or discomfort, and shortness of breath. If the patient has a history of hypertension, the doctor is motivated to confirm the diagnosis. There are other non-invasive blood pressure measurement methods such as pulse oximetry.\n\nIf the patient has non-insistent hypertension and a normal ankle-brachial index (ABI) then further examination through other methods such as echocardiogram are recommended.

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What is hypertension?

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Hypertension is the most common cardiovascular disease and the leading risk factor for death. The majority of hypertension cases are secondary to hypertension complications, such as stroke and myocardial infarction. In order to prevent and control hypertension, it is needed to maintain a healthy weight, smoke less, and have fewer meals in the course of a day.

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What is the latest research for hypertension?

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There is a great deal of research on the association between hypertensive heart disease and hypertension and cardiac arrhythmias. The role of hypertension and hypertensive heart disease on outcomes in end-stage renal disease, the elderly, and the black patient is not clear and requires further study.

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What does dietary counselling usually treat?

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Patients are not able to manage their diabetes, HT or CKD by their own actions. Their dietary counsellors inform, advise, motivate and inform. Nutrition and diet counselling should be regarded as one of the core components of preventive medicine. Dietitians in primary care are able to intervene timely to prevent progression to atherosclerotic and renal diseases, but only when patients are motivated to behave in a healthy lifestyle as well as their dietary counsellors are able to inform and advise them.

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Is dietary counselling typically used in combination with any other treatments?

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A positive recommendation for dietetic advice is rarely given, regardless of the patient's lifestyle, medical condition or disease status. This may be because patients do not see themselves as needing dietary advice and this is not seen as part of the therapeutic process. A referral should always be made and patients should consult with their dietitian if they have a high blood pressure or Type 2 diabetes.

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How does dietary counselling work?

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Findings from a recent study shows that dietary counselling alone is effective in improving BP lowering and lipid lowering. The counselling sessions need, however, to be carried out in such a way that it will be clearly evident for patients that the advice was heeded and that positive behaviour change occurred and this, in combination with lifestyle modifications, seems to enhance the patient's self-management. Further research is needed on the long-term impact of this intervention on BP control and other medical symptoms.

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How serious can hypertension be?

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Physicians overestimate the urgency of ambulatory care and undertreat the seriousness of the disease. The need for more aggressive clinical management could potentially be decreased by greater awareness of the severity of the risks of untreated hypertension, and the likelihood of clinical or subclinical cardiac events with the use of antihypertensives for those with a low likelihood of immediate benefits.

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Is dietary counselling safe for people?

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Despite being a short and simple intervention, our results show that dietary counselling improved nutritional intake, dietary compliance improved and reduced unhealthy behaviours in patients with non-communicable disease. In spite of positive findings, there is a need to ascertain the role and place of dietary counselling in our health system in order to ascertain and ensure its more widespread usage.

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