The aim of this trial is to investigate if modifications to exercise and diet can control blood pressure in patients with resistant hypertension. The main outcomes to be investigated are changes in systolic blood pressure (SBP – pressure when the heart is contracting), weight, fitness levels, and risk of cardiovascular disease (disease of the blood and heart vessels).
The details
Resistant hypertension is a condition where blood pressure is consistently high and usually requires treatment with three or more drugs. The risk of mortality and cardiovascular events, such as stroke, and heart attacks, are higher in patients with resistant hypertension. Intense drug treatment is not always effective or can cause unwanted side-effects.
Lifestyle changes are often recommended as a non-drug treatment for patients with hypertension. These include weight loss, increasing physical activity, and decreasing alcohol intake. The DASH diet (Dietary Approaches to Stop Hypertension) has also been developed to help lower blood pressure. This study will examine the effects of lifestyle intervention on fitness, dietary habits, and body weight in patients with resistant hypertension.
Who are they looking for?
This trial will recruit 150 patients with diagnosed resistant hypertension. Patients who have been taking 3 or more drugs and have an SBP greater than 140 mm HG or diastolic blood pressure (DBP – pressure when the heart is relaxed) greater than 90 mm Hg are eligible. Patients who have been taking 4 or more drugs and have an SBP greater than 130 mm HG or DBP greater than 85 mm Hg are also eligible. Patients must adhere to their prescribed medications and lead an inactive lifestyle.
Patients must not have secondary hypertension, asthma, lung disease, any life-threatening or -limiting illness (such as cancer), or severe heart disease. Patients must be able to take part in the fitness program assigned to them. Individuals with psychiatric disorders or a history of drug or alcohol abuse are not eligible. Participants must not be currently pregnant or have undergone prior gastric bypass surgery.
How will it work
Patients are randomly assigned to one of two groups. The first group will undergo a structured centre-based lifestyle intervention. This will consist of weekly visits to the centre for 16 weeks. They will receive instructions on the DASH diet for calorie and sodium intake. They will exercise 3 times per week under the supervision of trained staff.
The second group will receive standard education and advice. This includes encouragement to achieve ideal body weight and engage in regular exercise, but no special program will be delivered to enhance the participants' ability to comply with these recommendations.
Changes in blood pressure, weight, fitness, and risk of cardiovascular disease will be measured over a 4-months period.
