HypertensionNCT01835249
Effect of Intense vs. Standard Hypertension Management on Nighttime Blood Pressure - an Ancillary Study to SPRINT
A study testing Intensive BP Arm and Standard BP arm in people with Hypertension, run by University of Minnesota at 10 sites in United States.
Trial summary
Hypertension is a major risk factor for cardiovascular and renal disease, and a leading cause of premature mortality worldwide. Early hypertension studies showed that treating elevated blood pressure (BP) reduces patients' risk of cardiovascular disease and all-cause mortality. Read more about this study
- Who is it for?
- Ages 55 months and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Intensive BP Arm and Standard BP arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 897 participants
- Where
- 10 sitesUnited States
- Study dates
- Jun 2013to Jul 2017
- 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 55 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- eligible and enrolled in SPRINT at the 27 month follow up visit
- able and willing to provide informed consent
Who cannot join
- arm circumference >50cm
- shift worker or work regularly at night
- history of breast cancer requiring mastectomy
- end-stage renal disease
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of Alabama Birmingham
Birmingham, Alabama, 35294
Carolinas Medical Center
Charlotte, North Carolina, 28203
Louis Stokes Cleveland VA Medical Center
Cleveland, Ohio, 44129
Houston VA
Houston, Texas, 77030
Mayo Clinic
Jacksonville, Florida, 32224
Memphis VA
Memphis, Tennessee, 38104
Vanderbilt University
Nashville, Tennessee, 37235
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Utah
Salt Lake City, Utah, 84112
Washington DC VA Medical Center
Washington D.C., District of Columbia, 20422
About this study
Official title: Effect of Intense vs. Standard Hypertension Management on Nighttime Blood Pressure
Hypertension is a major risk factor for cardiovascular and renal disease, and a leading cause of premature mortality worldwide. Early hypertension studies showed that treating elevated blood pressure (BP) reduces patients' risk of cardiovascular disease and all-cause mortality. In subsequent research, patients achieved greater improvement in cardiovascular outcomes when their treatment was aimed at a moderate systolic BP target (<150mmHg) than at higher targets. Although observational data suggest that even lower BP targets may be beneficial, this has not been seen in randomized trials; instead, "intense" treatment of hypertension (i.e., to a target systolic BP <120mmHg) was found to have no effect on participants' risk for renal disease, cardiovascular disease, or all-cause mortality.
One potential explanation for this apparent lack of benefit of intense BP targets is that the study protocols targeted reductions in clinic BP rather than ambulatory BP. Ambulatory BP monitoring (ABPM) allows for assessment of BP throughout the day and night. Of all the BP measurements, nighttime systolic BP appears to be the best predictor of cardiovascular disease and all-cause mortality. Because recent trials assessing intense BP targets did not include ambulatory BP measurements, the effect of intensive treatment on nighttime BP is largely unknown.
Read more
To address this important gap in knowledge, we will conduct ABPM in 600 participants as part of an ancillary study to the ongoing Systolic Blood Pressure Intervention Trial (SPRINT). The goal of the ancillary study is to evaluate the effect of intensive vs. standard clinic based BP targets on nighttime BP (primary outcome), as well as night/day BP ratio, timing of peak BP, 24hr BP, and BP variability (secondary outcomes). The SPRINT trial includes approximately 9250 participants at high risk for cardiovascular disease.
The investigators hypothesize that intense targeting of clinic systolic BP does not lower nighttime systolic BP compared to a standard target.
- Conditions
- Hypertension
- Being tested
- Intensive BP Arm, Standard BP arm
- Keywords
- Hypertension, Nighttime blood pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive BP ArmOther
Participants in the Intensive arm have a goal of SBP <120 mmHg.
Standard BP armOther
Participants in the Standard BP arm have a goal of SBP <140 mmHg.
| Study group | Role | What they receive |
|---|---|---|
| Intensive BP Arm | Experimental | Participants randomized into the Intensive BP arm will have a goal of SBP <120mmHg. Drugs will be added and/or titrated at each visit (monthly) to achieve SBP <120 mmHg. At periodic "milepost" visits, addition of another drug will be "required" if not at goal. Receives: Other: Intensive BP Arm |
| Standard BP Arm | Active comparator | Participants randomized into the Standard arm will have a goal of SBP <140 mm Hg. Intensify therapy if SBP ≥160 mmHg @ 1 visit; ≥140 mmHg @ 2 consecutive visits; Down-titration if SBP <130 mmHg @ 1 visit; <135 mmHg @ 2 consecutive visits. Receives: Other: Standard BP arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nighttime systolic blood pressure
Ambulatory blood pressure monitoring will be performed within 3 weeks of the 27 month follow up visit. For the primary analysis, nighttime BP will be defined by narrow clock time (01:00 AM to 6:00 AM).
Measured: 27 month follow up visit
Secondary outcomes (4)
Night to day systolic BP ratio
Ambulatory blood pressure monitoring will be performed within 3 weeks of the 27 month follow up visit. The night to day systolic BP ratio will be calculated using narrow clock times.
Measured: 27 month follow up visit
Timing of peak BP
Ambulatory blood pressure monitoring will be performed within 3 weeks of the 27 month follow up visit. The timing of the peak BP will be calculated for each subject using cosinor rhythmometry analysis.
Measured: 27 month follow up visit
24hr average systolic BP
Ambulatory blood pressure monitoring will be performed within 3 weeks of the 27 month follow up visit. The average systolic BP will be calculated for each subject.
Measured: 27 month follow up visit
Blood pressure variability
Ambulatory blood pressure monitoring will be performed within 3 weeks of the 27 month follow up visit. Blood pressure variability will be defined by the standard deviation of the systolic blood pressure and by calculating the average real variability (ARV).
Measured: 27 month follow up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2017
- Study completionJul 2017
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 HypertensionStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 897 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Wake Forest University, Louis Stokes VA Medical Center, University of Pennsylvania, Carolinas Medical Center, Mayo Clinic, University of Utah, Vanderbilt University, University of Alabama at Birmingham, Michael E. DeBakey VA Medical Center, Memphis VA Medical Center, Washington D.C. Veterans Affairs Medical Center
- Responsible party
- Sponsor
- Investigators
- Paul E Drawz, MD, MHS, MS, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01835249
- Sponsor's protocol ID
- 1303M30341
- Other IDs
- 1303M30341
- Status last verified
- Jan 2019
- First submitted
- 16 Apr 2013
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Drawz PE, Pajewski NM, Bates JT, Bello NA, Cushman WC, Dwyer JP, Fine LJ, Goff DC Jr, Haley WE, Krousel-Wood M, McWilliams A, Rifkin DE, Slinin Y, Taylor A, Townsend R, Wall B, Wright JT, Rahman M. Effect of Intensive Versus Standard Clinic-Based Hypertension Management on Ambulatory Blood Pressure: Results From the SPRINT (Systolic Blood Pressure Intervention Trial) Ambulatory Blood Pressure Study. Hypertension. 2017 Jan;69(1):42-50. doi: 10.1161/HYPERTENSIONAHA.116.08076. Epub 2016 Nov 14.
PubMed 27849563
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intense vs. Standard Hypertension Management on Nighttime Blood Pressure
- ClinicalTrials.gov ID
- NCT01835249
- Acronym / sponsor ID
- 1303M30341
- Conditions
- Hypertension
- Keywords
- Hypertension, Nighttime blood pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 897 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Wake Forest University, Louis Stokes VA Medical Center, University of Pennsylvania, Carolinas Medical Center, Mayo Clinic, University of Utah, Vanderbilt University, University of Alabama at Birmingham, Michael E. DeBakey VA Medical Center, Memphis VA Medical Center, Washington D.C. Veterans Affairs Medical Center
- Study start
- Jun 2013
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 18 Apr 2013 (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.
Hypertension is a major risk factor for cardiovascular and renal disease, and a leading cause of premature mortality worldwide. Early hypertension studies showed that treating elevated blood pressure (BP) reduces patients' risk of cardiovascular disease and all-cause mortality. In subsequent research, patients achieved greater improvement in cardiovascular outcomes when their treatment was aimed at a moderate systolic BP target (<150mmHg) than at higher targets. Although observational data suggest that even lower BP targets may be beneficial, this has not been seen in randomized trials; instead, "intense" treatment of hypertension (i.e., to a target systolic BP <120mmHg) was found to have no effect on participants' risk for renal disease, cardiovascular disease, or all-cause mortality.
One potential explanation for this apparent lack of benefit of intense BP targets is that the study protocols targeted reductions in clinic BP rather than ambulatory BP. Ambulatory BP monitoring (ABPM) allows for assessment of BP throughout the day and night. Of all the BP measurements, nighttime systolic BP appears to be the best predictor of cardiovascular disease and all-cause mortality. Because recent trials assessing intense BP targets did not include ambulatory BP measurements, the effect of intensive treatment on nighttime BP is largely unknown.
To address this important gap in knowledge, we will conduct ABPM in 600 participants as part of an ancillary study to the ongoing Systolic Blood Pressure Intervention Trial (SPRINT). The goal of the ancillary study is to evaluate the effect of intensive vs. standard clinic based BP targets on nighttime BP (primary outcome), as well as night/day BP ratio, timing of peak BP, 24hr BP, and BP variability (secondary outcomes). The SPRINT trial includes approximately 9250 participants at high risk for cardiovascular disease.
The investigators hypothesize that intense targeting of clinic systolic BP does not lower nighttime systolic BP compared to a standard target.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive BP Arm | Experimental | Other: Intensive BP ArmParticipants randomized into the Intensive BP arm will have a goal of SBP <120mmHg. Drugs will be added and/or titrated at each visit (monthly) to achieve SBP <120 mmHg. At periodic "milepost" visits, addition of another drug will be "required" if not at goal. |
| Standard BP Arm | Active comparator | Other: Standard BP armParticipants randomized into the Standard arm will have a goal of SBP <140 mm Hg. Intensify therapy if SBP ≥160 mmHg @ 1 visit; ≥140 mmHg @ 2 consecutive visits; Down-titration if SBP <130 mmHg @ 1 visit; <135 mmHg @ 2 consecutive visits. |
Who may qualify
- Ages
- 55 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- eligible and enrolled in SPRINT at the 27 month follow up visit
- able and willing to provide informed consent
Key exclusion criteria (4 listed)
- arm circumference >50cm
- shift worker or work regularly at night
- history of breast cancer requiring mastectomy
- end-stage renal 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 |
|---|---|---|
| Intensive BP ArmParticipants in the Intensive arm have a goal of SBP <120 mmHg. | Other | Intensive BP Arm |
| Standard BP armParticipants in the Standard BP arm have a goal of SBP <140 mmHg. | Other | Standard BP Arm |
Primary outcome
Nighttime systolic blood pressure
Time frame: 27 month follow up visit
Ambulatory blood pressure monitoring will be performed within 3 weeks of the 27 month follow up visit. For the primary analysis, nighttime BP will be defined by narrow clock time (01:00 AM to 6:00 AM).
4 secondary outcomes
Night to day systolic BP ratio
Time frame: 27 month follow up visit
Timing of peak BP
Time frame: 27 month follow up visit
24hr average systolic BP
Time frame: 27 month follow up visit
Blood pressure variability
Time frame: 27 month follow up visit
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 25 Jan 2019.
- Results publication: PubMed 27849563Drawz PE, Pajewski NM, Bates JT, Bello NA, Cushman WC, Dwyer JP, Fine LJ, Goff DC Jr, Haley WE, Krousel-Wood M, McWilliams A, Rifkin DE, Slinin Y, Taylor A, Townsend R, Wall B, Wright JT, Rahman M. Effect of Intensive Versus Standard Clinic-Based Hypertension Management on Ambulatory Blood Pressure: Results From the SPRINT (Systolic Blood Pressure Intervention Trial) Ambulatory Blood Pressure Study. Hypertension. 2017 Jan;69(1):42-50. doi: 10.1161/HYPERTENSIONAHA.116.08076. Epub 2016 Nov 14.
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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.
Paul E Drawz, MD, MHS, MS principal investigator
University of Minnesota
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive BP Arm and Standard BP arm in people with Hypertension, run by University of Minnesota at 10 sites 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 2 inclusion and 4 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 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
Nighttime systolic blood pressure (time frame: 27 month follow up visit). 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 NCT01835249, 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 25 Jan 2019.