Neurocognition, Lifestyle Modification, and Treatment Resistant Hypertension

Treatment-Resistant Hypertension Clinical Trial

Official title:

Neurocognition, Lifestyle Modification, and Treatment Resistant Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03001427
• Other study ID #: Pro00055703_1
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: December 14, 2020

Study information

• Verified date: March 2021
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This application proposes to extend an ongoing NHLBI clinical trial (NCT02342808) examining the efficacy of a lifestyle intervention combining the Dietary Approaches to Stop Hypertension (DASH) diet with caloric restriction and aerobic exercise to lower and control BP in individuals with RH. In the parent trial, participants with RH will be randomized to either: (1) a 4-month adjunctive lifestyle intervention designed to lower BP through exercise and diet (C-LIFE), or; (2) a standardized education and physician advice (SEPA) control condition.

The current protocol will collect additional assessments of neurocognition (executive function, processing speed, and memory), endothelial function (brachial artery flow-mediated dilation), and cerebrovascular reserve (a measure of prefrontal cortex tissue oxygenation) in 120 participants at baseline, following completion of the 4-month intervention, and again after one year, in order to examine neurocognitive improvements and their potential mediators.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: December 14, 2020
• Est. primary completion date: February 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Hypertension
• Treatment-Resistant Hypertension

Intervention

Behavioral:
• Structured center-based lifestyle intervention

• Standard education and physician advice

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Blumenthal JA, Sherwood A, Smith PJ, Mabe S, Watkins L, Lin PH, Craighead LW, Babyak M, Tyson C, Young K, Ashworth M, Kraus W, Liao L, Hinderliter A. Lifestyle modification for resistant hypertension: The TRIUMPH randomized clinical trial. Am Heart J. 2015 Nov;170(5):986-994.e5. doi: 10.1016/j.ahj.2015.08.006. Epub 2015 Aug 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Executive Function composite	Trail Making Test Part B, Stroop Color-Word Section, Animal Naming, COWA, CVLT-II Discrimination Index	Baseline to follow-up (1 year)
Other	Processing Speed composite	Trail Making Test Part A, Stroop Word Section, Stroop Color Section, Digit Symbol, Ruff 2&7 Test	Baseline to follow-up (1 year)
Other	Memory composite	CVLT-II Learning, CVLT-II Free Recall, RCFT Recall, Digit Spa	Baseline to follow-up (1 year)
Primary	Executive Function composite	Trail Making Test Part B, Stroop Color-Word Section, Animal Naming, COWA, CVLT-II Discrimination Index	Baseline to immediate post-treatment (4 months)
Primary	Processing Speed composite	Trail Making Test Part A, Stroop Word Section, Stroop Color Section, Digit Symbol, Ruff 2&7 Test	Baseline to immediate post-treatment (4 months)
Primary	Memory composite	CVLT-II Learning, CVLT-II Free Recall, RCFT Recall, Digit Spa	Baseline to immediate post-treatment (4 months)
Secondary	Brachial Artery Flow-Mediated Dilation		Baseline to immediate post-treatment (4 months)
Secondary	Prefrontal Cortex Tissue Oxygenation Index		Baseline to immediate post-treatment (4 months)