Treatment-Resistant HypertensionTRIUMPHNCT02342808
Lifestyle Interventions in 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 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… 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
- Jun 2015to 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
Official title: Treating Resistant Hypertension Using Lifestyle Modification to Promote Health
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.
Read the detailed description
The term resistant hypertension (RH) is defined as clinic blood pressure (BP) that remains above goal (e.g., systolic blood pressure [SBP]>140 mm Hg and/or diastolic blood pressure [DBP]>90 mm Hg), despite adherence to a regimen of 3 or more antihypertensive medications of different classes, one of which is a diuretic.
With the growing prevalence of hypertension (HTN) in this country, RH is a major public health concern, affecting more than 7.5 million Americans. Patients with RH are 50% more likely to experience a CVD event, including stroke, kidney failure, myocardial infarction, and death, compared to patients with controlled BP. There is an urgent need for developing RH management strategies to lower BP as well as to reduce the high risk of CVD-related events. Lifestyle modifications, including exercise training and dietary modification, are of proven efficacy in lowering BP in unmedicated patients with HTN and are often recommended as the first step for treating high BP. The Dietary Approaches to Stop Hypertension (DASH) diet has been shown to lower BP in HTN patients who are not treated with drugs. Moreover, when the DASH diet is combined with exercise and caloric restriction, even greater, and quite marked, BP reductions can be achieved. However, the efficacy of these lifestyle modifications in HTN patients who are refractory to medical therapy is unknown. This application aims to build upon evidence supporting the value of lifestyle modifications in unmedicated patients with HTN by proposing a randomized clinical trial (RCT) that will evaluate whether an intensive, medically-supervised lifestyle intervention can successfully lower BP in medicated patients with RH.
- 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
Participants will meet with interventionists weekly for 16 weeks and receive instruction on the DASH diet with caloric and sodium restriction and will exercise three times per week at one of the designated CR facilities, under the supervision of medically trained staff, 3 times per week for 16 weeks.
Standard education and physician adviceBehavioural
Participants will receive routine medical care provided by the participants' primary care physician(s) supplemented by an educational session on hypertension management. Participants will receive a dietary consultation from the study nutritionist and an individualized exercise prescription from an exercise physiologist, but not participate in a structured program. Participants will be free to engage in diet and exercise for the 16-week intervention.
| 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.
Change in clinic systolic blood pressure
Measured: Baseline to immediate post-treatment (4 months)
Secondary outcomes (5)
Change in 24-hour ambulatory systolic blood pressure
Measured: Baseline to immediate post-treatment (4 months)
Weight
Measured: Immediate post-treatment (4 months)
Aerobic capacity (Measured via an exercise treadmill stress test with VO2 collection)
Measured via an exercise treadmill stress test with VO2 collection
Measured: Immediate post-treatment (4 months)
DASH Diet adherence (Measured via food diary recall)
Measured via food diary recall
Measured: Immediate post-treatment (4 months)
Change in Cardiovascular Disease (CVD) biomarker composite score
Biomarkers of interest include: left ventricular hypertrophy, arterial stiffness, baroreceptor reflex sensitivity, insulin resistance, lipid profiles, sympathetic nervous system (SNS) activity, and inflammatory markers
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 posted21 Jan 2015 (estimated)
- Study startJun 2015
- Primary completion8 May 2020
- Study completion14 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- James A. Blumenthal, PhD, Principal investigator, Duke UniversityAndrew Sherwood, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02342808
- Sponsor's protocol ID
- Pro00055703
- Other IDs
- 1R01HL122836-01A1
- Acronym
- TRIUMPH
- Status last verified
- Feb 2021
- First submitted
- 15 Jan 2015
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Blumenthal JA, Smith PJ, Mabe S, Hinderliter A, Craighead L, Watkins LL, Ingle K, Tyson CC, Lin PH, Kraus WE, Liao L, Sherwood A. Effects of Lifestyle Modification on Psychosocial Function in Patients With Resistant Hypertension: SECONDARY OUTCOMES FROM THE TRIUMPH RANDOMIZED CLINICAL TRIAL. J Cardiopulm Rehabil Prev. 2024 Jan 1;44(1):64-70. doi: 10.1097/HCR.0000000000000801. Epub 2023 May 24.
PubMed 37220236Blumenthal JA, Hinderliter AL, Smith PJ, Mabe S, Watkins LL, Craighead L, Ingle K, Tyson C, Lin PH, Kraus WE, Liao L, Sherwood A. Effects of Lifestyle Modification on Patients With Resistant Hypertension: Results of the TRIUMPH Randomized Clinical Trial. Circulation. 2021 Oct 12;144(15):1212-1226. doi: 10.1161/CIRCULATIONAHA.121.055329. Epub 2021 Sep 27.
PubMed 34565172Smith PJ, Mabe SM, Sherwood A, Doraiswamy PM, Welsh-Bohmer KA, Burke JR, Kraus WE, Lin PH, Browndyke JN, Babyak MA, Hinderliter AL, Blumenthal JA. Metabolic and Neurocognitive Changes Following Lifestyle Modification: Examination of Biomarkers from the ENLIGHTEN Randomized Clinical Trial. J Alzheimers Dis. 2020;77(4):1793-1803. doi: 10.3233/JAD-200374.
PubMed 32925039Blumenthal 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 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Resistant Hypertension Using Lifestyle Modification to Promote Health
- ClinicalTrials.gov ID
- NCT02342808
- Acronym / sponsor ID
- TRIUMPH / Pro00055703
- Conditions
- Treatment-Resistant Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jun 2015
- Primary completion
- 8 May 2020 (actual)
- Study completion
- 14 Dec 2020 (actual)
- First posted
- 21 Jan 2015 (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 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.
Detailed description
The term resistant hypertension (RH) is defined as clinic blood pressure (BP) that remains above goal (e.g., systolic blood pressure [SBP]>140 mm Hg and/or diastolic blood pressure [DBP]>90 mm Hg), despite adherence to a regimen of 3 or more antihypertensive medications of different classes, one of which is a diuretic.
With the growing prevalence of hypertension (HTN) in this country, RH is a major public health concern, affecting more than 7.5 million Americans. Patients with RH are 50% more likely to experience a CVD event, including stroke, kidney failure, myocardial infarction, and death, compared to patients with controlled BP. There is an urgent need for developing RH management strategies to lower BP as well as to reduce the high risk of CVD-related events. Lifestyle modifications, including exercise training and dietary modification, are of proven efficacy in lowering BP in unmedicated patients with HTN and are often recommended as the first step for treating high BP. The Dietary Approaches to Stop Hypertension (DASH) diet has been shown to lower BP in HTN patients who are not treated with drugs. Moreover, when the DASH diet is combined with exercise and caloric restriction, even greater, and quite marked, BP reductions can be achieved. However, the efficacy of these lifestyle modifications in HTN patients who are refractory to medical therapy is unknown. This application aims to build upon evidence supporting the value of lifestyle modifications in unmedicated patients with HTN by proposing a randomized clinical trial (RCT) that will evaluate whether an intensive, medically-supervised lifestyle intervention can successfully lower BP in medicated patients with RH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 interventionParticipants will meet with interventionists weekly for 16 weeks and receive instruction on the DASH diet with caloric and sodium restriction and will exercise three times per week at one of the designated CR facilities, under the supervision of medically trained staff, 3 times per week for 16 weeks. | Behavioural | Structured center-based lifestyle intervention |
| Standard education and physician adviceParticipants will receive routine medical care provided by the participants' primary care physician(s) supplemented by an educational session on hypertension management. Participants will receive a dietary consultation from the study nutritionist and an individualized exercise prescription from an exercise physiologist, but not participate in a structured program. Participants will be free to engage in diet and exercise for the 16-week intervention. | Behavioural | Standard education and physician advice |
Primary outcome
Change in clinic systolic blood pressure
Time frame: Baseline to immediate post-treatment (4 months)
5 secondary outcomes
Change in 24-hour ambulatory systolic blood pressure
Time frame: Baseline to immediate post-treatment (4 months)
Weight
Time frame: Immediate post-treatment (4 months)
Aerobic capacity (Measured via an exercise treadmill stress test with VO2 collection)
Time frame: Immediate post-treatment (4 months)
DASH Diet adherence (Measured via food diary recall)
Time frame: Immediate post-treatment (4 months)
Change in Cardiovascular Disease (CVD) biomarker composite score
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 4 Feb 2021.
- Derived from this study: PubMed 37220236Blumenthal JA, Smith PJ, Mabe S, Hinderliter A, Craighead L, Watkins LL, Ingle K, Tyson CC, Lin PH, Kraus WE, Liao L, Sherwood A. Effects of Lifestyle Modification on Psychosocial Function in Patients With Resistant Hypertension: SECONDARY OUTCOMES FROM THE TRIUMPH RANDOMIZED CLINICAL TRIAL. J Cardiopulm Rehabil Prev. 2024 Jan 1;44(1):64-70. doi: 10.1097/HCR.0000000000000801. Epub 2023 May 24.
- Derived from this study: PubMed 34565172Blumenthal JA, Hinderliter AL, Smith PJ, Mabe S, Watkins LL, Craighead L, Ingle K, Tyson C, Lin PH, Kraus WE, Liao L, Sherwood A. Effects of Lifestyle Modification on Patients With Resistant Hypertension: Results of the TRIUMPH Randomized Clinical Trial. Circulation. 2021 Oct 12;144(15):1212-1226. doi: 10.1161/CIRCULATIONAHA.121.055329. Epub 2021 Sep 27.
- Derived from this study: PubMed 32925039Smith PJ, Mabe SM, Sherwood A, Doraiswamy PM, Welsh-Bohmer KA, Burke JR, Kraus WE, Lin PH, Browndyke JN, Babyak MA, Hinderliter AL, Blumenthal JA. Metabolic and Neurocognitive Changes Following Lifestyle Modification: Examination of Biomarkers from the ENLIGHTEN Randomized Clinical Trial. J Alzheimers Dis. 2020;77(4):1793-1803. doi: 10.3233/JAD-200374.
- Derived from this study: 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.
Related trials for Treatment-Resistant Hypertension
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
RecruitingPhase 2
Study of TX000045 in Participants With Pulmonary Hypertension Due to Interstitial Lung Disease
Hypertension, Pulmonary, Lung Diseases, Interstitial
Enrolling by invitationObservational study
Heart Rate Variability and Medication Adherence in Resistant Hypertension
Resistant Hypertension, Medication Adherence
RecruitingPhase 4
Antihypertensive Mechanisms of Minocycline in Resistant Hypertension
Hypertension, Resistant to Conventional Therapy
Not yet recruiting
The RESPLASH Study
Resistant Hypertension
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.
James A. Blumenthal, PhD principal investigator
Duke University
Andrew Sherwood, PhD principal investigator
Duke University
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 4 Feb 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?
Change in clinic systolic blood pressure (time frame: Baseline to immediate post-treatment (4 months)). 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 NCT02342808, which also lists 4 linked publications.
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 4 Feb 2021.