Treatment-Resistant HypertensionNCT03001427
Neurocognition, Lifestyle Modification, and Treatment Resistant Hypertension
A study testing Structured center-based lifestyle intervention and Standard education and physician advice in people with Treatment-Resistant Hypertension, run by Duke University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Treatment-Resistant Hypertension
- What is being tested?
- Structured center-based lifestyle intervention and Standard education and physician advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 14 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
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.
- Conditions
- Treatment-Resistant Hypertension
- Being tested
- Structured center-based lifestyle intervention, Standard education and physician advice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured center-based lifestyle interventionBehavioural
Standard education and physician adviceBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Structured center-based lifestyle intervention | Experimental | The Structured center-based Lifestyle Intervention (C-LIFE) will include individualized plans for the DASH diet, weight management, and aerobic exercise. Receives: Behavioral: Structured center-based lifestyle intervention |
| Standard education and physician advice | Experimental | The Medical Management with Standardized Education and Physician Advice (SEPA) will consist of encouragement to achieve an ideal body weight and engage in exercise as part of routine counseling in primary care, but no special program will be delivered to enhance the participants' ability to comply with these recommendations. Receives: Behavioral: Standard education and physician advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Executive Function composite
Trail Making Test Part B, Stroop Color-Word Section, Animal Naming, COWA, CVLT-II Discrimination Index
Measured: Baseline to immediate post-treatment (4 months)
Processing Speed composite
Trail Making Test Part A, Stroop Word Section, Stroop Color Section, Digit Symbol, Ruff 2\&7 Test
Measured: Baseline to immediate post-treatment (4 months)
Memory composite
CVLT-II Learning, CVLT-II Free Recall, RCFT Recall, Digit Spa
Measured: Baseline to immediate post-treatment (4 months)
Secondary outcomes (2)
Brachial Artery Flow-Mediated Dilation
Measured: Baseline to immediate post-treatment (4 months)
Prefrontal Cortex Tissue Oxygenation Index
Measured: Baseline to immediate post-treatment (4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2016 (estimated)
- Study startJan 2016
- Primary completion27 Feb 2020
- Study completion14 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Treatment-Resistant HypertensionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03001427
- Sponsor's protocol ID
- Pro00055703_1
- Status last verified
- Mar 2021
- First submitted
- 20 Dec 2016
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 26542509
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurocognition, Lifestyle Modification, and Treatment Resistant Hypertension
- ClinicalTrials.gov ID
- NCT03001427
- Acronym / sponsor ID
- Pro00055703_1
- Conditions
- Treatment-Resistant Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- 27 Feb 2020 (actual)
- Study completion
- 14 Dec 2020 (actual)
- First posted
- 23 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structured center-based lifestyle intervention | Experimental | Behavioral: Structured center-based lifestyle interventionThe Structured center-based Lifestyle Intervention (C-LIFE) will include individualized plans for the DASH diet, weight management, and aerobic exercise. |
| Standard education and physician advice | Experimental | Behavioral: Standard education and physician adviceThe Medical Management with Standardized Education and Physician Advice (SEPA) will consist of encouragement to achieve an ideal body weight and engage in exercise as part of routine counseling in primary care, but no special program will be delivered to enhance the participants' ability to comply with these recommendations. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured center-based lifestyle intervention | Behavioural | Structured center-based lifestyle intervention |
| Standard education and physician advice | Behavioural | Standard education and physician advice |
Primary outcome
Executive Function composite
Time frame: Baseline to immediate post-treatment (4 months)
Trail Making Test Part B, Stroop Color-Word Section, Animal Naming, COWA, CVLT-II Discrimination Index
Processing Speed composite
Time frame: Baseline to immediate post-treatment (4 months)
Trail Making Test Part A, Stroop Word Section, Stroop Color Section, Digit Symbol, Ruff 2\&7 Test
Memory composite
Time frame: Baseline to immediate post-treatment (4 months)
CVLT-II Learning, CVLT-II Free Recall, RCFT Recall, Digit Spa
2 secondary outcomes
Brachial Artery Flow-Mediated Dilation
Time frame: Baseline to immediate post-treatment (4 months)
Prefrontal Cortex Tissue Oxygenation Index
Time frame: Baseline to immediate post-treatment (4 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Background: PubMed 26542509Blumenthal 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured center-based lifestyle intervention and Standard education and physician advice in people with Treatment-Resistant Hypertension, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Executive Function composite (time frame: Baseline to immediate post-treatment (4 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03001427, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2021.