Lifestyle Interventions in Treatment-Resistant Hypertension
Completed · Not applicable
Conditions studied: Treatment-Resistant Hypertension
In brief
This study will examine the effects of lifestyle intervention on fitness, dietary habits, and body weight in patients with resistant hypertension (RH). Patients will be randomized to either a 4-month adjunctive lifestyle intervention designed to lower BP that will be delivered in a center-based CR program (C-LIFE), or to standardized education and physician advice (SEPA) designed to promote the same healthy behaviors and reflecting the current highest possible standard of care for promoting a healthy lifestyle in RH.
Key facts
- Study ID
- NCT02342808
- Run by
- Duke University
- People needed
- 140
- Starts
- 2015-06-01
- Expected to finish
- 2020-12-14
- Last updated by the study team
- 2021-02-04
Who can join
Age: 35 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Documented resistant hypertension (RH). In the absence of a specific RH diagnosis, individuals being treated for two or more weeks with 3 antihypertensive medications of different classes, including a diuretic if tolerated, with clinic SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg, will be eligible. Individuals being treated with 4 or more antihypertensive medications, including a diuretic if tolerated, with SBP ≥ 120 or DBP ≥ 80 mm Hg will also be eligible.
- Adherent to prescribed medications
- Overweight (BMI ≥ 25 kg/m2)
- Sedentary
- Willing to be randomized to one of the 2 treatment groups and able to fully participate in intervention
- Informed consent
You may not qualify if…
- Secondary HTN, non-adherence to anti-HTN medications
- Severe CKD (eGFR <40 ml/min/1.73m2)
- Severe ischemic heart disease (CCS Class 3 or 4 angina or evidence of ischemia at <85% heart rate reserve on treadmill testing)
- Severe heart failure (NYHA association Class 3 or 4), high grade arrhythmias, severe valvular heart disease
- Severe asthma or chronic obstructive lung disease
- Diabetes requiring insulin
- Musculoskeletal or neurologic problems that would preclude participation in aerobic exercise training
- Major psychiatric disorder, a history of drug abuse, alcohol consumption >14 drinks/week
- Life-limiting comorbid medical condition such as cancer
- Prior gastric bypass surgery
- Currently pregnant
- Cognitively impaired
Where it is running
- Duke University Medical Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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